cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic Blepharitis

The purpose of this study is to evaluate the clinical efficacy and safety of Tobradex ST compared to AzaSite in the treatment of moderate to severe chronic blepharitis.


Eligibility Criteria:
Inclusion Criteria:

* Have diagnosis of moderate to severe chronic blepharitis defined by a minimum score of at least "1" for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye
* Have a minimum global score (the total signs and symptoms score) of 5 in the same eye qualifying.

Exclusion Criteria:

* Have known sensitivity or poor tolerance to the test article (tobramycin, dexamethasone, azithromycin) or its components or any therapy associated with the trial
* Have a history of ocular surgical intervention within six (6) weeks prior to Visit 1 or during the study
* Have any ocular infections (bacterial, viral or fungal) - active ocular inflammation (i.e. follicular conjunctivitis, iritis) or preauricular lymphadenopathy, other than blepharitis
* Have worn contact lenses in the 72 hours prior to visit 1 and for the duration of the study
* Are currently taking any medication known to cause ocular drying that has not been on a stable dose for at least 30 days
* Have used any topical ocular or systemic antibiotics within 7 days of enrollment. Stable (greater than 1 month prior to enrollment) use of topical antibiotics on the face (except around the eyes) for dermatologic conditions is allowed. Dose must continue unchanged for duration of study
* Have used any topical ocular - aerosolized/nebulized - or systemic corticosteroid agents within 14 days of enrollment. Stable (greater than 1 month prior to enrollment) use of inhaled (using mouthpiece) and nasal corticosteroids and topical dermal steroids (except around the eyelids) are allowed. Dose must continue unchanged for the duration of the study.
Do Vacutainers With Animal Characters Reduce Fear and Anxiety?

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using vacutainers of three different animal characters.

In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to compare the effects of vacutainers of three different animal characters on fear, anxiety, and pain in children during bloodletting.

The study is a prospective, randomized and controlled trial.Children aged 4 to 7 years who required blood draw were divided into three groups; two groups: experimental and control groups. Animal characters (butterfly, peacock and rabbit) chosen by children in the experimental group was attached to the vacutainer, and then their blood was drawn. The data were obtained by face-to-face interviews with the child, parent and observer before and after the procedure. Children's pain and fear/anxiety levels were evaluated using the Children's Fear Scale and theWong-Baker FACES Pain Scale, respectively.

The study population consisted of children aged 4 to 7 years who presented to the children's blood draw room of the hospital.

Sample of the study consisted of a total of 1800 children who met the sample selection criteria and were selected via randomization method.

Data were collected using the Interview and Observation Form, Children's Fear Scale, and Wong-Baker FACES Pain Rating Scale.

Eligibility Criteria:
Inclusion Criteria:

* The child was selected by simple randomization.
* The child was between 4-7 years old.
* The child and parent were informed and their written consent was obtained prior to the procedure.
* The bloodletting procedure was performed by the same nurse.
* The child was given standard information before the bloodletting procedure.
* The needle used for the bloodletting procedure was of the same thickness.
* The child could evaluate the pain and fear scales.

Exclusion Criteria:

* The child was excluded from the study if they had the following criteria;
* The child had infection, skin integrity disturbance, and rash in the area where the procedure would be performed.
* The child had nerve damage in the previously treated area.
* The child's health status was critical and unstable.
* The child had developmental retardation that prevents them from responding to pain and fear scales.
* The child had taken any analgesic in the last 6 hours before the bloodletting procedure.
* The child did not want to participate.
* The child did not meet the selection criteria for the experimental and control groups.
Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema

To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.

Uveitis, an intraocular inflammatory disease, is the cause of about 10 percent of visual impairment in the United States. Uveitis may lead to many sight-threatening conditions, including cataract, vitreal opacities, glaucoma, and, most commonly, cystoid macular edema. Reduction of swelling or edema within the retina depends on the movement of fluid from the retina through the choroid. A number of studies indicate that this process requires active transport of fluid ions by the retinal pigment epithelium and may involve the carbonic anhydrase system. Current treatment of uveitis-associated cystoid macular edema requires the use of immunosuppressive or anti-inflammatory agents. However, many patients are either resistant or intolerant to this therapy. Recent reports suggested that acetazolamide, a carbonic anhydrase inhibitor that is used to lower intraocular pressure in some glaucoma patients, might be safe and effective in reducing uveitis-associated cystoid macular edema.

Because the course of ocular inflammatory disease can be variable, a double-masked, randomized, crossover trial was designed to test the efficacy of acetazolamide compared with a placebo for the treatment of uveitis-associated cystoid macular edema. Randomized adult patients received either oral acetazolamide sodium 500 mg or a matched placebo every 12 hours for the first 4 weeks of the study. Children 8 years of age or older received a lesser dose based on body weight. Following a 4-week period, during which no medication was given, patients then received a 4-week course of the opposite medication. Primary end points included reduction in cystoid macular edema (graded on fluorescein angiography) and improvement in visual acuity (measured on standardized Early Treatment Diabetic Retinopathy Study \[ETDRS\] charts). Laser acuity was also assessed as a secondary outcome variable. Adverse effects of the acetazolamide therapy were monitored by clinical and laboratory examinations.

A total of 40 patients were recruited for the study. Patients were seen at the beginning of the study for baseline measurements and at 4, 8, and 12 weeks after enrollment into the study.

Eligibility Criteria:
Males and females 8 years of age or older and weighing at least 35 kg (77 lb) were eligible for the study. Patients had to have a best corrected visual acuity of 20/40 or worse in at least one eye with cystoid macular edema demonstrable on fluorescein angiography.

Patients were allowed to receive systemic therapy for their uveitis. Exclusion criteria included current use of acetazolamide as part of a therapeutic regimen; a history of hypersensitivity reactions to acetazolamide, sulfonamides, or angiography dye; unclear ocular media that would obscure fluorescein angiography; macular subretinal neovascularization or a macular hole; or inability to take acetazolamide for medical reasons.
A Study of GDC-0941 in Participants With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered once daily (QD) and twice daily (BID) in the treatment of advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically documented, incurable, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen, and who are not candidates for regimens known to provide clinical benefit
* Evaluable or measurable disease per RECIST
* Life expectancy of greater than or equal to (\>/=) 12 weeks
* Documented willingness to use an effective means of contraception (for both men and women) while participating in the study

Exclusion Criteria:

* Leptomeningeal disease as the only manifestation of the current malignancy
* History of Type 1 or 2 diabetes mellitus requiring regular medication
* Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for \>/=3 months
* Active congestive heart failure or ventricular arrhythmia requiring medication
* Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
* Active infection requiring intravenous (IV) antibiotics
* Requirement for any daily supplemental oxygen
* Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal (LLN), or hypercalcemia above the upper limit of normal (ULN) for the institution despite adequate electrolyte supplementation or management
* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
* Known human immunodeficiency virus (HIV) infection
* Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk from treatment complications
* Significant traumatic injury within 3 weeks before Day 1
* Major surgical procedure within 4 weeks prior to initiation of study treatment
* Treatment with chemotherapy, hormonal therapy (except gonadotropin releasing hormone \[GnRH\] agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment
* Palliative radiation to bony metastases within 2 weeks prior to initiation of study treatment
* Need for chronic corticosteroid therapy for greater than (\>) 7 days
HRQOL in Prostate Cancer Patients Treated With Radiotherapy

The study primarily aims at evaluating health-related quality of life after radiotherapy for prostate cancer, using modern hypofractionated radiotherapy schedules. Study design is a prospective observational cohort study. All patients give written informed consent and fill out online validated questionnaires before, during, and after radiotherapy (yearly) up to 5 years post-treatment.

Rationale: Patient-Reported Outcomes (PROs), such as health-related quality of life (HRQL), have achieved an important role in the evaluation of benefits and harms after cancer treatment, including radiotherapy for prostate cancer (PCa). In the past year, clinical radiotherapy protocols at the Erasmus MC have been changed for external beam radiotherapy (EBRT) as well as for brachytherapy (BT). In order to evaluate the current, changed, clinical practice, we will conduct a prospective cohort study, with the main purpose to assess HRQL for the current treatment options at the Erasmus MC.

Objective: To establish HRQL (start treatment - 5 years after treatment) in a prospective cohort of ≈600 patients with localized PCa treated with radiotherapy within in the period ≈ 1/3/2019 - 1/12/2023.

Main objective: to establish changes in HRQL levels (with respect to baseline) up to 5 year post-treatment, within each radiotherapy modality for prostate cancer patients, i.e. EBRT 60 Gy in 20 fractions, EBRT 42.7 Gy in 7 fractions, CyberKnife (stereotactic EBRT) 38 Gy in 4 fractions, BT 27 Gy in 2 fractions, postoperative EBRT (PORT) 72 Gy in 36 fractions, EBRT for LN+: 70 Gy (prostate)/52 Gy (lymph nodes) in 28 fractions.

Study design: Prospective observational cohort study. Study population: Patients with prostate cancer T1c-T4 referred for radiotherapy at the Erasmus MC as a primary treatment with curative intent or as first line adjuvant treatment after a prostatectomy.

Intervention: All interventions are according to applicable standard clinical procedures \& protocols for localized prostate cancer of the Radiotherapy department.

Main study parameters/endpoints: HRQL scores of the EPIC (urinary domain, bowel domain), and the IIEF-5 (sexual function) score.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no additional risks or benefits for patients that participate in the study. The additional burden is to fill out questionnaires at regular intervals.

Eligibility Criteria:
Inclusion Criteria:

* Clinically T1c-T4, N0 (or N+ in case of EBRT-LN+), M0 prostate cancer patient referred for radiotherapy.
* Willing and capable to fill out Dutch questionnaires on health-related items at a computer (online questionnaires).
* Signed written Informed Consent.

Exclusion Criteria:

* Previously radiation treatment in the pelvic region, for any reason.
* Diagnosed with other tumor in the past 12 months or known with tumor progression of another tumor.
* Postoperative radiotherapy with dose levels \< 72 Gy.
Lipid Rich Necrotic Core Lesion Detected by Cardiac Magnetic Resonance Imaging (CMR)

The purpose of this study is to evaluate whether some features of plaques in coronary arteries predispose the heart muscle to injuries during angioplasty in patients with a narrowing in at least one of the arteries that may need a stent placed during a heart catheterization. Participants undergo a cardiovascular magnetic resonance imaging (MRI) study before the heart catheterization to look for scarring in the heart muscle. During the heart catheterization, participants undergo an intravascular ultrasound (IVUS) exam to look at the make-up of the plaques before the stent placement and the investigators will measure the pressures in the arteries to look at how severe the blockage is. Within 30 days after the heart catheterization, participants will have a second MRI done to look for any new scar in the heart muscle.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 90 years
* Patients with known obstrucive coronary arterial disease for PCI in a native coronary artery
* Ability and willingness to consent and Authorization for use of personal health information (PHI)
* Ability and willingness to the required follow up procedures

Exclusion Criteria:

* An acute myocardial infarction in the vascular territory of interest.
* History of percutaneous coronary intervention in the major epicardial vessel of interest
* Lesion characteristics that preclude IVUS
* The presence of delayed enhancement in the territory of the study vessel on baseline CMR
* Patients with current history of cardiomyopathy which is known to cause enhancement on CMR study
* Patients who are considered hemodynamically unstable based on clinical assessment by the physician
* Patients with Class IV congestive heart failure at time of enrollment
* Patients with poorly controlled hypertension with SBP \>/= 210mmhg and/or DBP \>/=140 hypertension unable to be treated, at time of enrollment
* GFR\</=30 pre-procedure per institutional standards
* Patients with any known co-morbid conditions that is limiting their life expectancy to \< 1year
* A known contraindication to Adenosine, including but not limited to:
* Moderate to severe hyperactive airway disease such as asthma and severe COPD
* Second or third degree AV block
* Known sinus node disease, such as sick sinus syndrome or symptomatic bradycardia
* Known hypersensitivity to Adenosine
* A known contraindication to MRI
* Electronically, magnetically, and mechanically activated implants
* Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, and cardiac pacemakers
* Metallic splinters/fragments in sensitive tissues including the eye, brain, spinal cord etc...
* Ferromagnetic haemostatic clips in the central nervous system
* A known contraindication to Gadolinium
* Patients with history of allergic reactions to gadolinium based contrast
* Patients with glomerular filtration rate (GFR) \</= 30ml/min
* Inability or unwillingness to consent and Authorization for use of PHI
* Patients who are unwilling or unable to follow up
* Known pregnancy
Serratus Anterior Plane Block and Transthoracic Plane Block in Pectus Surgery

The most important problem in the postoperative period in patients scheduled for pectus deformity correction surgery is pain. Due to the catastrophic neurological complications of thoracic epidural analgesia, the tendency towards plane blocks has been increasing in recent years. Serratus Plane Block (SAP Block), performed under ultrasound guidance, is used to treat pain in thoracic surgery. However, whether it has an effect on sternum pain is still controversial and there are not enough studies. Transversus thoracic plane block (TTP Block) provides effective analgesia in sternotomies. For this reason, we aimed to show that the TTP block added to the SAP block will provide more effective analgesia in order to provide adequate analgesia for the pressure and pain sensation of the bars placed on the sternum in pectus surgery.

The most important problem in the postoperative period in patients scheduled for pectus deformity correction surgery is pain. It is very important for patients to start active breathing exercises and mobilize early. Complications develop less frequently in patients who actively breathe and mobilize early. The tolerability of the surgery by the patient and the absence of pain in the postoperative period ensure early discharge . Due to the catastrophic neurological complications of thoracic epidural analgesia, the tendency towards plane blocks has been increasing in recent years. Serratus Plane Block (SAP Block), performed under ultrasound guidance, is used to treat pain in thoracic surgery. However, whether it has an effect on sternum pain is still controversial and there are not enough studies. Transversus thoracic plane block (TTP Block) provides effective analgesia in sternotomies. For this reason, we aimed to show that the TTP block added to the SAP block will provide more effective analgesia in order to provide adequate analgesia for the pressure and pain sensation of the bars placed on the sternum in pectus surgery.

Eligibility Criteria:
Inclusion Criteria:

Patients who will undergo surgery due to pectus deformity All patients over the age of 15 who will be operated on due to pectus deformity

Exclusion Criteria:

* Known allergy to local anesthetics,
* Uncooperative patient,
* The patient who refuses to participate in the study,
* Patients under 18 years of age.
A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female at least 18 years of age
* Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
* Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) \>=3 out of 68 and swollen joint count (SJC) \>=3 out of 66
* Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
* Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
* Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO
* Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry

Exclusion Criteria:

* Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
* Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
* Subject has an active infection or a history of recent serious infections
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
* Subject had acute anterior uveitis within 6 weeks of Baseline
* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
* Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
* Presence of active suicidal ideation, or moderately severe major depression or severe major depression
* Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening