cyrilzakka/clinical-trials huggingface dataset:
Absorption and Systematic Pharmacokinetics of IDP-121 Lotion in Subjects With Acne Vulgaris

Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant metabolites after topical dermal application of IDP-121 lotion.

Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant metabolites after topical dermal application of IDP-121 lotion in subjects with moderate to severe acne vulgaris under maximal use conditions.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, between the ages of 9 and \<17 years (16 years 11 months inclusive).
* Written and oral informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or legal guardian must sign the informed consent.
* Subject must have a score of 3 (moderate) to 4 (severe) on the Evaluator's Global Severity Assessment at the screening and baseline visit in the facial area.
* Subjects with facial acne inflammatory lesions count no less than 20 but no more than 40.
* Subjects with facial acne non-inflammatory lesions count no less than 20 but no more than 100.

Key Exclusion Criteria:

* Use of investigational drug or device within 30 days of enrollment or participation in research study or concurrent study with this study.
* Any dermatological conditions on the face that could interfere with clinical evaluations acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinical significant rosacea, gram negative folliculitis.
* Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
* Subjects with facial beard or mustache that could interfere with any study assessments.
Effectiveness of an Integrated Care Program on Asthma Control and Inhaled Corticosteroids Adherence

The investigators propose to implement and evaluate an integrated care program for enhancing the care of patients with asthma in a region of Quebec province, Canada. The investigators will implement our intervention in a family medicine group practice setting and plan to deliver it to 150 experimental group subjects. The investigators will simultaneously study 300 control subjects who are receiving usual care in other regions of the province of Quebec. Our hypothesis is that the program will improve the quality of life of patients with asthma exposed to the program, asthma control, inhaled corticosteroid adherence, knowledge of asthma, and a number of variables that relate to the conceptual model selected as a framework for this study (the PRECEDE-PROCEED model of Green and Kreuter).


Eligibility Criteria:
Inclusion Criteria:

Individuals aged 12 to 45 years, for whom the pharmacists had dispensed at least one anti-asthma drug in the previous six months were screened and randomly contacted by phone. Those who reported an asthma diagnosis and who were using a short-acting beta-2-agonist (SABA) \>3 times a week (except before exercise) or a corticosteroid (inhaled or oral), irrespective of frequency were included.

Exclusion Criteria:

Pregnancy, no prior asthma diagnosis, participation in an ongoing respiratory study, or another respiratory illness.
Utilization of Target Ranges to Treat Parkinson's Disease With the PKG

The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological examination).

This is a randomized controlled trial (RCT) to evaluate treating uncontrolled patients with Parkinson's Disease (PwP) to a target range as suggested by expert review papers. The study aims to evaluate clinical patient outcomes, quality of life measures and health care utilization of those patients specifically treated to a target range when using the PKG data in the clinical management of Parkinson's disease (PD) in routine clinical care (treatment group) compared to those managed with medical history and clinical evaluation alone (control group) performed by a neurologist experienced in PD management. Both groups will be recommended to undergo medication changes until they reach a "controlled state" that is determined by either the clinician using standard of care (SOC) (PKG- Group) or using PKG based targets and SOC assessments (PKG+ Group).

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to sign a written informed consent for study participation
* Presumed to have Levodopa responsive idiopathic Parkinson's Disease
* Age inclusive at the time of consent per PKG Indications for Use (46-83 years old)
* Has not been previously managed with the PKG

Exclusion Criteria:

* Contraindication to increasing levodopa (e.g. orthostatic hypotension, hallucinations/psychosis or any other medical condition in the last year that would preclude increasing levodopa or other appropriate Parkinson's Disease medications)
* MoCA score \<23 at screening visit
* Diagnosis of Essential Tremor
* Wheelchair bound or bedridden
* Currently utilizing or planning in the next 6 months advanced PD therapies (DBS, infusion, etc.)
* In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints (e.g., subject unable to complete PKG watch wear instructions per Patient Instruction Manual)
Study of Photodynamic Therapy (PDT) in Patients With Central Serous Chorioretinopathy (CSC)

The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC.


Eligibility Criteria:
Inclusion Criteria:

* patients with CSC
* patients signed the ICF
* patients with course of CSC less than 6 months
* patients did not undertake any treatment for CSC

Exclusion Criteria:

* patients with porphyria
* patients allergic to verteporfin
* pregnant or nursing women
* poor patients compliance
* sever liver dysfunction
* dioptric media opacities which make it difficult to exam fundus
Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors

RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This laboratory study is studying cerebrospinal fluid proteins and angiogenesis proteins in young patients with newly diagnosed central nervous system tumors.

OBJECTIVES:

Primary

* Investigate the feasibility of centrally collecting and processing high-quality cerebrospinal fluid (CSF) samples from pediatric patients with newly diagnosed central nervous system tumors for proteomic studies.
* Identify protein markers that might indicate the presence of a brain tumor using CSF samples collected from these patients.

OUTLINE: This is a multicenter study.

Patients undergo cerebrospinal fluid (CSF) collection from any or all of the following 5 sites: lumbar, cervical, ommaya, intra-operative (ventricular, cisternal), and/or external ventricular drain. CSF is obtained within 8 weeks of diagnosis but prior to (or concurrent with) the initiation of any post-operative therapy (excluding corticosteroids).

CSF samples are examined for proteomic biomarkers by 2D gel electrophoresis, low-mass fingerprinting, and stable isotope labeling.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed CNS tumors of any of the following histologies:

  * Diffuse pontine gliomas\*
  * Focal/infiltrative tumors, including any of the following:

    * High- and low-grade gliomas
    * Gangliogliomas
    * Ependymomas
    * Oligodendrogliomas
    * Craniopharyngioma
    * Dysembryoplastic neuroepithelial tumors
    * Other low-grade neoplasms
  * Optic pathway gliomas\*
  * Seeding tumors, including any of the following:

    * Germ cell tumors (germinomas and nongerminomas)
    * Embryonal tumors, including any of the following:

      * Medulloblastoma
      * Pineoblastoma
      * Supratentorial primitive neuroectodermal tumors
      * Atypical teratoid/rhabdoid tumor
      * Other embryonal tumors NOTE: \*Histological requirement waived
* Newly diagnosed disease
* Cerebrospinal fluid (CSF) obtained as part of CSF diversion, initial diagnosis/staging, or administration of intrathecal chemotherapy (at the initiation of postoperative therapy)

PATIENT CHARACTERISTICS:

* Less than 22 years of age

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy or chemotherapy
* Prior corticosteroids allowed
Cervical Laminectomy With or Without Lateral Mass Fixation in Cervical Spondylotic Myelopathy

The cervical spine consists of seven cervical vertebrae joined by intervertebral disks and a complex network of ligaments. The cervical spine has a normal lordotic curve, and it is much more mobile than the thoracic or lumbar regions of the spine, which makes it more liable to both degenerative and traumatic disorders .

Degenerative cervical myelopathy (DCM) is the most common form of spinal cord dysfunction in adults. The incidence and prevalence of myelopathy due to degeneration of the spine are estimated at a minimum of 41 and 605 per million in North America and Incidence of cervical spondylotic myelopathy-related hospitalizations has been estimated at 4.04/100,000 person-years.

Degenerative cervical myelopathy (DCM), earlier referred to as cervical spondylotic myelopathy, Patients report neurological symptoms such as pain and numbness in limbs, poor coordination, imbalance, and bladder dysfunction.

Surgical management for patients with multilevel cervical myelopathy aims to decompress the spinal cord and restore the normal sagittal alignment using either an anterior approach or a posterior approach. Multilevel anterior surgery is associated with complications such as increased surgical trauma and increased incidence of pseudarthrosis, graft dislodgement, and implant failure as the number of level increases.The posterior approach is optimal for multilevel stenosis using consecutive laminectomies However, although the effectiveness of cervical laminectomy was documented repeatedly, there were still concerns over postoperative kyphotic deformity, cervical instability, and late deterioration Cervical laminectomy and fusion may be performed to avoid the potential complications of instability and kyphosis associated with cervical laminectomy alone. For the latter, dissection and removal of the posterior elements disrupts the normal biomechanics of the cervical spine, leading to post laminectomy deformity and instability Our study aim to evaluate the multilevel cervical laminectomy alone, and multilevel cervical laminectomy with lateral mass fixation in patients with cervical spondylotic myelopathy regarding the Clinical and radiological outcome for short term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Signs and symptoms of spondylotic myelopathy at two or more level cervical canal stenosis after full filling clinical and radiological criteria

Exclusion Criteria:

* History of previous cervical intervention like (anterior cervical approach and laminoplasty ).
* History of cervical trauma.
* History of other neurological disorders such as( Multiple sclerosis , stroke,AML,....ETC).
* patient with insuffient data.
* Uncontrolled DM, hypertension and thyroid disorders.
* Osterpenic or osteoporotic patients
Psychometric Properties of Adapted Turkish Version of ISYQOL Questionnaire in Patients With AIS

The ISYQOL questionnaire was translated into Turkish and was assessed the psychometric properties of the Turkish version of the ISYQOL in terms of test-retest reliability, internal consistency, and construct validity in this research.

HRQOL is considered one of the most relevant outcomes of both conservative and surgical treatment of scoliosis, for this reason, several questionnaires (e.g. SRS-24 and SRS-22) have been developed. SRS-22 has been reported as the most commonly used scale to measure HRQOL in patient with scoliosis in many countries. However, current literature showed that SRS-22 has poor measurement properties, it does not satisfy fundamental measure requirements, i.e. additivity, generalizability and unidimensionality. According to Rasch analysis study SRS-24 and SRS-22 presents high ceiling effects in conservative care, for the reason that was developed for surgical candidates. The Italian Spine Youth Quality of Life (ISYQOL) questionnaire originally in Italian, is the first HRQOL questionnaire developed according to the Rasch analysis. It was developed in a conservative treatment setting for all type of spinal deformities, including also patients with surgical curves. The ISYQOL has recently been translated into English, however, its adaptation to the Turkish language is necessary for use in the Turkish population. The psychometric properties of any scale may be affected by translation into another language, that's why it is important for the scale to be evaluated psychometrically. Therefore, the purpose of this study was to translate the ISYQOL questionnaire to Turkish and to assess the psychometric properties of the Turkish version of the ISYQOL in terms of test-retest reliability, internal consistency and construct validity when used on patients with idiopathic scoliosis. Adolescent girls with idiopathic scoliosis who applied to Formed Scoliosis Treatment and Brace Center between September 2018 to 2020 are inviting in this stud by mailing

Eligibility Criteria:
Inclusion Criteria:

* who has diagnosed with AIS
* aged 10 to 18 years
* curvature between 10 ° to 45 ° ,
* native Turkish speaker adolescents who accepted to participate in the study and approved by their parents.

Exclusion Criteria:

* non-idiopathic scoliosis
* history of spinal surgery,
* spinal trauma, tumor, infection
Effect of Online Information Cards Education on Women's Perception of Family Planning Behaviors in the Postpartum Period

It is emphasized that the contraception knowledge of women in Turkey is insufficient and the rate of use of modern family planning methods should be increased. In this study, it is aimed to evaluate the effect of family planning education given via online information canrds on women's perception of disability, attitudes and behaviors in the postpartum period. The study is planned to be conducted in a randomized controlled experimental type using the Solomon four-group design. In the study, it is planned to make up a total of 150 women determined by using the G\*Power program. The research will be carried out online with the women followed in Ankara Etlik City Hospital-Gynecology Hospital Obstetrics Clinics.

The data of the research will be collected with Introductory Information Form, Family Planning Method Usage History Form, Perception of Obstacles in Using Contraceptive Methods Scale and Family Planning Attitude Scale. The data will be analyzed using the SPSS 25.0 program. In the evaluation of the data; descriptive statistics, independent sample t-test, paired samples t-test, anova will be used.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in Turkey Ankara Etlik City Hospital-Gynecology Hospital Obstetrics Clinics on the dates of the research
* Having had a cesarean or normal birth
* Being sexually active
* Being a woman aged 18 or over who has given birth
* Volunteering to participate in research
* Having the ability to read and understand Turkish
* Having a smart phone and internet access to access online information cards

Exclusion Criteria:

* Women with tubal ligation after cesarean section
* Women whose partner has had a vasectomy
* Women who received an Intrauterine Device at the time of delivery
Vistakon Investigational Multi-purpose Contact Lens Care Solution.

This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.


Eligibility Criteria:
Inclusion Criteria:

* must be an adapted contact lens wearer
* best corrected distance visual acuity must be 20/25 or better in each eye
* must be wearing their habitual lenses on a daily wear basis
* must be willing to refrain from swimming during the study

Exclusion Criteria:

* any systemic diseases that may interfere with contact lens wear
* any clinically significant ocular disease
* any ocular infection
* use of certain medications
* any grade 2 or greater slit lamp findings
* any know sensitivity to marketed contact lens care solutions
* currently pregnant or lactating
* monovision corrected
Prescribing Opioid Pain Relievers in the Emergency Department: Understanding and Optimizing the Encounter

The investigators overall study objective is to improve patients knowledge and safe use of opioid pain relievers upon discharge from the Emergency Department.

Recent studies indicate that emergency department (ED) discharge processes - including written and spoken communications - are inadequate, and patients often leave without the knowledge necessary to properly care for themselves. In the context of opioid pain relievers, this lack of knowledge is potentially dangerous, as patients may not possess the requisite knowledge for safe use of their medication or an awareness of the dangers of medication misuse.

The aim of this study was to evaluate the impact of an opioid information sheet and spoken counseling on patient knowledge about opioids and safe use behaviors. The investigators conducted a randomized controlled pilot test of a dual-modality educational intervention (written information sheet and spoken counseling about opioids) to assess if the intervention can increase patient knowledge about opioid pain relievers. These activities were intended to guide future modification of educational interventions and the future development of best practices for emergency physician spoken counseling about opioid pain relievers.

Eligibility Criteria:
Inclusion Criteria:

* prescribed an opioid pain reliever
* English Speaking

Exclusion Criteria:

* Non-English Speaking
* Clinically unstable, psychologically impaired or intoxicated as judged by the research staff member.
* Chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days.
* admitted to hospital
* unable to complete follow up phone interview in 4 - 7 days.
Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

Determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus on diet and exercise therapy

Exclusion Criteria:

* Patients with type 1 diabetes mellitus
Collection of Circulating Tumor Cells From the Peripheral Blood of Metastatic Breast Cancer Patients

To address the challenges of isolating and analyzing rare cells, this study aims to validate the instrumentation, the test protocols, and the analysis of patient's outcome to show the instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In order to facilitate the validation process, investigators will only focus on metastatic patients for whom CTCs supposedly present at higher abundance. Investigators propose to enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from these patients before they start any new line of therapy as determined by their doctors. The specific aims are to isolate, enumerate and analyze the number and/or molecular information of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging, and molecular profiling techniques. Investigators will use this study to optimize diagnostic instrumentation, test blood processing protocols and CTC analysis algorithm. During this study investigators will collect patients' clinical information related to cancer, as well as the patients' survival status to validate the system's prognosis ability.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Progressive and measurable metastatic breast cancer.
3. Commencement of new anti-cancer chemotherapy or palliative care.
4. ECOG performance status equal or less than grade 2.

Exclusion Criteria:

1. Subject has received any investigational agent, not explicitly approved by MiCareo, within last one year.
2. Subject being identified with any blood borne infectious disease.
3. Subject has received anticancer chemotherapy within last one month. (not including hormone therapy, or target therapy)
4. Pregnancy.
Down Syndrome Autonomic Nervous System Induction Bradycardia

Children with Down syndrome (DS) often experience dangerously low heart rates on induction of anesthesia for routine procedures and this occurs at 10 times the rate of non-DS patients. Given that the cardiac output of children is heart rate dependent, bradycardia is especially perilous in this population.

Historically, individuals with DS were not expected to survive beyond childhood; consequently, correction of congenital anomalies, e.g. cardiac defects, was not frequently offered. Fortunately, today individuals with DS live into adulthood and surgical correction of anomalies is universally offered. Thus, increasing numbers of children with DS are exposed to anesthesia and at risk for this hemodynamic catastrophe. It is medically unacceptable and an autonomic nervous system mechanism will be sought.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are overtly healthy as determined by medical evaluation including lack of diagnosis of Down Syndrome and children with Down Syndrome

Exclusion Criteria:

1. Contraindication to adhesive placement, eg, epidermolysis bullosa
2. Patient or parent refusal
3. Opioids
4. Heart rate altering therapy such as beta blockers
5. During the study period, participants will abstain from ingesting caffeine- or xanthine-containing products (eg, coffee, tea, cola drinks, and chocolate) for \[6 hours\] before the start of the anesthetic.
6. Participants will be assumed not to be using tobacco or alcohol during the study period due to their young age.
A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2 dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of ABBV-221 in participants with advanced solid tumors likely to exhibit elevated levels of Epidermal Growth Factor Receptor (EGFR).


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2.
* Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme).
* Has an archived, diagnostic tumor tissue available for analysis.
* Has adequate hematologic, renal, cardiac and hepatic function.
* Expanded Safety Cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.

Exclusion Criteria:

* Previously received an EGFR-directed monoclonal antibody within the past 4 weeks.
* Has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as \> Grade 1 on Common Terminology Criteria for Adverse Events.
* History of major immunologic reaction to any IgG containing agent.
* Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.