cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome

This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared with placebo in dry eye syndrome.

Eligible subjects are randomly assigned to receive 3% DA-6034, 5% DA-6034 or Placebo. This study is conducted for 6 weeks(Run-in Period 2 weeks + Treatment Period 4 weeks).

Eligibility Criteria:
Inclusion Criteria:

1. Age≥20
2. Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months
3. Fluorescein corneal staining score ≥ 4 and Schirmer test I ≤ 7mm in same eye
4. Corrected vision ≥ 0.2 in both eye
5. Have given a written, informed consent

Exclusion Criteria:

1. Ocular disorder that may confound interpretation of study results
2. Current treatment for glaucoma or IOP over 25mmHg
3. Ocular surgery history within 1 year
4. Other malignancy history or uncontrolled severe disease within 5 years
5. Use of systemic immunosuppressive therapies within 3 months
6. Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks
7. Received any other investigational drugs within 4 weeks
8. Subjects who are willing to wear contact lenses during study participation
9. Pregnant or lactating women
An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris

This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve hours for two weeks, in pediatric patients 9 to less than 12 years of age with acne vulgaris. Adrenal suppression effects and systemic safety are an important safety concern. The current study is designed to investigate these potential concerns under maximal use conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patient must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide written informed consent for the patient.
* Patient has moderate to severe facial acne vulgaris as determined by the Investigator and obvious acne on the trunk (i.e., shoulders, upper chest, and/or back).
* Females of childbearing potential must be using highly effective birth control methods with a negative urine pregnancy test (UPT) at study start.
* Patient must be in general good health with normal renal function and no clinically relevant abnormalities present at study start.
* Patient and parent/guardian are able to communicate with the staff and are willing to comply with study instructions, reside at and/or return to the clinic for required visits.

Exclusion Criteria:

* Patient is pregnant, lactating, or is planning to become pregnant during the study.
* Patient has a Body Mass Index (BMI) for age percentile \> 95%.
* Patient has any skin or medical condition, including facial hair that could interfere with the evaluation of the test article or requires the use of interfering topical or systemic therapy.
* Patient has received an investigational drug or been treated with an investigational device within 30 days prior to study start.
* Patient is currently enrolled in an investigational drug or device study.
* Patient has any condition which, in the investigator's opinion, would make it unsafe for the patient to participate in this research study.
* Patient has known allergy or sensitivity to CB-03-01 or any of its ingredients
* Patient has participated in a previous CB-03-01 study.
Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)

The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Primary Insomnia
* Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights
* Patient is willing to avoid alcohol on PSG visits
* Patient will avoid napping during the course of the study
* Patient's bedtime is between 9pm and 1am

Exclusion Criteria:

* History of substance abuse, bipolar disorder or psychotic disorder
* Difficulty sleeping due to other medical condition
* History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome
* History of neoplastic malignancy within the last 5 years
* Positive alcohol breath test during the screening visits
Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis

The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.

POPULATION 2 (surgical sample of arterialized venous segment from removal of previous AVF): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to reoperation for correction of complication and/or new AVF by proximalization, as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.

The following study will enroll two cohorts of patients: 75 patients from Population 1 and 75 patients from Population 2, according to the inclusion criteria. Since this is an exploratory study, this number is considered sufficient to observe and compare tissue markers associated with early AVF stenosis.

Patients will be treated according to clinical practice in accordance with the physician's judgment.

The study includes: the recruitment of patients from the two study populations, the obtaining of the surgical specimen from both populations and its sending to the Pathology Department, as part of the normal care pathway, the execution of three tissue samples at the Pathology Department: (i) a sample frozen in liquid nitrogen and stored in an ultrafreezer at -80°C for RT-PCR analysis; (ii) a sample placed in PBS for cell culture; (iii) the remainder of the sample fixed in formalin, embedded in paraffin and processed according to the normal care pathway and histological diagnosis. 2 µm slices will be cut from the paraffin block for histological staining and histochemical and IIC investigations; execution of cell culture investigations and execution of RT-PCR investigations.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years;
* Patients candidates for first AVF for hemodialysis or correction of AVF complication, as part of the normal care pathway;
* Obtaining informed consent signed by the patient

Exclusion Criteria:
Immediate Implant Placement With Platlet Rich Fibrin as Space Filling Material Versus the Use of Deprotienized Bovine Bone (Tutogen) in Maxillary Premolars.

20 subjects suffering from non restorable maxillary premolar teeth will be randomly devided into two groups. the selected teeth will be extracted and immeiate implants will be placed in all subjects. the first group will recieve deprotienized bovine bone (tutogen) to fill the buccal space between the implant and the bone, the second group will recieve platlet rich fibrin to fill the buccal space between the implant and the bone


Eligibility Criteria:
Inclusion Criteria:

* non restorable maxillary premolars non smoker free from any systemic disease or medication that could impair normal bone healing

Exclusion Criteria:

* any systemic disease that could affect bone healing patient with lesion related to the surgical site
Impact of Abdominal Incompetence on Urinary Incontinence After Prostatectomy (PROSTABDO)

the aim of this study is assess deep abdominal wall (ultrasonography of transversus abdominis muscle) before prostatectomy, and look at one year post surgery if patient with several incontinence are the same who have dysfunction (abdominal incompetence) before the surgery.


Eligibility Criteria:
Inclusion Criteria:

* male with prostate cancer going to have a robotic-assisted laparoscopic radical prostatectomy

Exclusion Criteria:

* neurological patology with bladder impact (SCI, parkinson disease, multiple sclerosis....)
* urinary incontinence before surgery
* surgery for abdominal wallhernia
Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique

The HIV infection not fully controlled, despite being under antiretroviral treatment, could make virus resistance against the antiretroviral treatments, making hardest the well control of HIV infection. The purpose of this research study is to confirm or deny if a not fully good controlled HIV infection could develop virus resistance against antiretroviral drugs that can difficult the good control of the HIV infection.

This research study consists of a single visit, in which you will be taken an additional vial of blood to analyze the presence or absence of mutations in your virus to HIV drugs. In addition, other HIV infection routine information will be recorded:

* Demographic data
* HIV infection history data
* Virological failure information
* Laboratory parameters Resistance tests techniques: Genotyping resistance test will be performed from plasma samples in those patients with viral load over 200 copies/ml, using ultracentrifugation if needed (Inzaule, Seth C et al. J Antimicrob Chemother, 2018). Briefly, RNA will be extracted and HIV-1 pol gene will be amplified, followed by a nested-PCR. Amplification products will be purified, quantified and finally diluted and prepared for sequencing following Illumina DNA Sample Preparation Kit protocol (Illumina, San Diego, CA). Samples will finally be pooled and sequenced in a MiSeq System (Illumina). MiSeq sequences will be downloaded from Basespace (Illumina) and analysed using PASeq (IrsiCaixa,Barcelona,ES), v1.4.18 (https://www.paseq.org). The questionnaire about clinical and demographic characteristics will be performed during the study visit

Eligibility Criteria:
Inclusion Criteria:

* Patients able to understand and sign the informed consent form.
* Documented HIV-1 infection.
* Under the first line TLD for at least 6 months.
* At least 3 months follow-up with CV \&amp;amp;gt;200c/ml.

Exclusion Criteria:

* Patients \&amp;amp;lt;18 years of age.
* Under the first line regime other than TLD.
* Patients with active neoplastic processes.
* Patients with active opportunistic diseases.
* Patients unable to give informed consent.
Prevalence of Musculoskeletal Disorders of Upper Limb in Type 1 Diabetes Patients

Osteopenia and osteoporosis, particularly related to insulinopenia, are common in type 1 diabetes and increase the risk of fractures. Musculoskeletal disorders of the upper limb are a common complication of type 1 diabetes. However, there is no official recommendation for screening for musculoskeletal disorders in France.

The aim of the study is to describe prevalence of musculoskeletal disorders of upper limb in type 1 diabetes patients.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* aged of 18 and more
* with type 1 diabetes
* agreeing to participate in the study

Exclusion Criteria:

* none
Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations

intraoperative opioid administration versus intraoperative pterygopalatine ganglion block based opioid free anesthesia to compare outcomes such as postoperative administration of opioid rates of nausea and vomiting, Post Anesthesia Care Unit (PACU) length of stay

Group A ;( opioid based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.

Group B ;( opioid free pterygopalatine ganglion block based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.

For each patient, intraoperative hemodynamics, additional intraoperative analgesia required, the length of PACU stay, administration of postoperative opioids, administration of postoperative non-opioid analgesics, postoperative (visual analogue score) VAS score, will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 13 years old.
* Elective tonsillectomy or adenotonsillectomy surgery

Exclusion Criteria:

* Allergies to xylocaine.
* Developmental delays.
* Significant cognitive impairment.
* American Society of Anesthesiologists (ASA) Class 3 and 4.
* Patients who underwent any additional concurrent procedures such as lingual tonsillectomy.
Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice

A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns of Samsca in routine medical practice.

A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca when used in a real-life setting.

Drug Utilisation Survey The drug utilisation analysis will describe the number of prescriptions, their distribution between different medical specialties, and indication for use as compared to the SmPC, patient age and patient gender distributions on a prescription level. In addition, the indication for use will be further categorised as

* SIADH
* Non-SIADH hyponatraemia
* Non-Hyponatraemia

Post-Authorisation Safety Study

Sodium levels at baseline and rate of sodium correction under therapy will be analysed. Safety findings will be described. The number of all non-serious and serious adverse events and the relative frequencies will be analysed in consideration of the risk categories below:

* Renal safety
* Aquaresis-related adverse effects
* Serum sodium correction rate
* Glucose homeostasis
* Cardiovascular safety and hemodynamics
* Respiratory system
* Drug metabolism and drug interactions
* Drug exposure during pregnancy
* Paediatric safety

Subgroup analyses will be performed for all safety findings by indication subgroups (SIADH and other indications), subgroups according to SIADH-underlying diseases, age groups, hepatically impaired patients and renally impaired patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are treated with Samsca

Exclusion Criteria:

* Patients who have not signed the data consent form
The Effects of Post-hospitalization Telehealth Care in the Patients Who Admitted Via Emergency Department

The investigators will perform and evaluate a post-hospitalization telecare system for compensating the discontinuity from the hospitalist care system.

At present, Taiwan's population has become an aging society since recent decade. Those older than 65 years had achieved 10.4% in 2008. Meanwhile, the proportion of hosts with underlying comorbid illness or immunocomprised status is increasing worldwide. In the trend of aging population, telehealth care will be important to extend the care system in post-hospitalization home care. In the past, thelehealth care has shown a good executive performance in the patients with congestive heart failure and post-operation follow-up. However, in dealing the patients with acute illness needing hospitalization, the telehealth system has not implemented yet. In regard to National health insurance (NHI) of Taiwan, hospitalization costs a lot in overall budget. Reduction of re-hospitalization in those with/without co-morbidity is a important issue for Taiwan NHI. Therefore, we plan to conduct the telehealth care system in post-hospitalization course in those admitted from emergency department. We observe the re-hospitalization rate and analyze the risk factors. In addition, we hypothesize the telehealth care will decrease the rate of re-hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Discharged alive from our hospitalist-care ward to home care
* Match diagnosis of general medicine

Exclusion Criteria:

* Younger than 18 years
* Discharged to care facility other than home
* Died in hospital
* Communication deficits
* No telephone at home
* Patient or family refused
Brain-derived Neurotrophic Factor (BDNF) Single Nucleotide Gene Polymorphism and Nerve Growth Factor as Risk Factors That Increase Severity of Allergic Rhinitis

Allergic diseases such as asthma, allergic rhinitis (AR) and atopic dermatitis affect more than 25% of the world population and are the leading cause of illness in children. The complex interplay between genetic, environmental and immunological risk factors results in the manifestation of allergic diseases . The pathological presentation of allergic disease involves the activation of both the innate and adaptive immune systems, resulting in a multifaceted response in specific target tissues such as the airways . This response results in the recruitment of inflammatory cells to target tissues and the production of specific IgE antibodies, cytokines and other inflammatory mediators \[11\], \[12\]. It is well established that allergic inflammation triggers neuronal dysfunction, which activates specific inflammatory mechanisms, potentially leading to structural changes in the diseased tissue . Neurotrophins are a family of structurally related proteins initially discovered to be involved in regulating neuronal development and now known to govern both peripheral and central nerve growth.

BDNF is a secretory protein belonging to the neurotrophin family and is involved in a range of neural processes during human development \[19\], \[20\]. In the early stages of development BDNF is essential for neurogenesis, survival and maturation of neuronal pathways. In the adult, alongside neurotransmitters, hormones and other neurotrophins, BDNF maintains synaptic plasticity, dendritic growth and the consolidation of long-term memory. The biological effect of BDNF is mediated via its binding to the trkB receptor. The activation of these receptors on eosinophils may be important in regulating the inflammatory cascade leading to allergic disease \[15\], \[24\]. Neurotrophin mediated activation of bronchial eosinophils might therefore play a role in the regulation of eosinophilic inflammation in allergic asthma .

The BDNF gene is located on chromosome 11p13 and is alternatively spliced resulting in several different transcripts \[26\]. Genetic polymorphisms in BDNF have been associated with allergic phenotypes such atopic dermatitis \[27\] and asthma \[28\], \[29\], \[30\], \[31\] in different populations. The functional polymorphism rs6265 (Val66Met) has been shown to regulate intracellular trafficking and affect the secretion of BDNF \[32\]. Nerve growth factor (NGF), a neurotrophin that is expressed in the glandular, nasal epithelium, and peripheral nerves in the nasal mucosa, has been shown to induce biochemical and structural changes in nerves that can lead to hyper-responsiveness \[33\], \[34\], \[35\] The biological effects of neurotrophins are mediated by binding either to the high-affinity tyrosine kinase (trk) receptors or to the low-affinity receptors known as pan-neurotrophin receptor p-75.


Eligibility Criteria:
Inclusion Criteria:

* The chronic AR patients on anti-allergic .

Exclusion Criteria:

* The chronic AR patients on anti-allergic therapy will be excluded.
Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles

Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects will be monitored for a period of 90 days post treatment.

Study results will be assessed with the following:

* Lemperle Scale
* Investigator GAIS Scale
* Subject Satisfaction Scale

Eligibility Criteria:
Inclusion Criteria:

* Males and females 40-70 years of age
* Fitzpatrick Skin Type I to IV as judged by the Investigator
* Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
* Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits.

Exclusion Criteria:

* Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
* History of keloid formation or hypertrophic scarring
* History of trauma or surgery to the treatment areas in the past 6 months
* Scar present in the areas to be treated
* Silicone injections in the areas to be treated
* Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)
* Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
* Active, chronic, or recurrent infection
* History of compromised immune system or currently being treated with immunosuppressive agents
* History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
* Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
* Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
* History or presence of any clinically significant bleeding disorder
* Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study
* Treatment with an investigational device or agent within 30 days before treatment or during the study period
Improving Lung Cancer Screening Adherence by Overcoming Barriers for Vulnerable Populations

This study investigates multi-level barriers to lung cancer screening uptake and adherence to lung cancer screening. Identifying cost- and convenience-related barriers to lung cancer screening may help researchers develop targeted strategies to facilitate screening adherence specifically among vulnerable populations.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred to the Jefferson LCSP and eligible for lung cancer screening by our standard criteria (United States Preventive Services Task Force, Center for Medicaid and Medicare Services, and/or National Comprehensive Cancer Network group II guidelines) will be eligible for inclusion in the study
* Additionally, individuals must provide a signed and dated informed consent form to participate in the survey portion of this study

Exclusion Criteria:

* Non-English-speaking individuals
* Individuals who lack consent capacity