cyrilzakka/clinical-trials huggingface dataset:
Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose

The aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.

PCV is generally recognized as a subtype of wet AMD characterized by the presence of aneurysmal orange-red polypoidal lesions with or without branching vascular network (BVN) in the choroidal vasculature as observed on indocyanine angiography (ICGA), representing 13% to 54.7% of newly diagnosed patients with neovascular AMD. Fifty percent of PCV had persistent leakage or recurrent bleeding with poor visual outcome, if left untreated.

And in the EVEREST study has shown that synergistic effects of anti-VEGF and vPDT combination: vPDT strongly regress polyp and anti-VEGF control to up-regulation of VEGF induced by vPDT compared to ranibizumab monotherapy in newly diagnosed PCV patients. Additionally, combination offers an opportunity for individualized treatment with potentially fewer treatments and less costs.

Therefore, the aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.

Eligibility Criteria:
Inclusion Criteria:

1. Age equal to or older than 50 years
2. Insufficient responder to ranibizumab Tx
3. ICGA-confirmed PCV
4. BCVA letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts
5. Ability to provide written informed consent and comply with study assessments for the full duration of the study

Exclusion Criteria:

1. Prior treatment with other anti-VEGF treatments in the study eye.
2. Prior treatment with other anti-VEGF treatments within 3 months prior to Visit 1 in the non-study eye.
3. Prior treatment with verteporfin within 6 months prior to Visit 1 in the study eye.
4. Prior treatment with verteporfin within 7 days prior to Visit 1 in the non-study eye.
5. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
6. Previous submacular surgery in the study eye
7. A history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia
8. Experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma
9. Previous participation in a clinical trial involving anti-angiogenic drugs
10. Intraocular surgery: 2 months before Visit 1 in the study eye.
11. Previous participation in any studies of investigational drugs
12. Administration of periocular, intravitreal, or systemic corticosteroid in the previous 3 months.
Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis

Primary Objective:

To assess the efficacy of the new hard boiled Ambroxol lozenges 20 mg for the relief of sore throat pain in patients with acute pharyngitis.

Secondary Objective:

To assess the safety of the new hard boiled Ambroxol lozenges 20 mg in patients with acute pharyngitis.

Duration per participant is up to 4 days.

Eligibility Criteria:
Inclusion criteria:

* Adult male or female patients complaining of sore throat due to acute pharyngitis with an onset no more than 72 hours prior to Visit 1.
* Patients with a score of 6 or greater on a 0-10-point pain intensity numerical rating scale.
* Signed written informed consent.

Exclusion criteria:

Patients suffering from pharyngitis of bacterial origin.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold

The German-Austrian ABSORB Register shall provide an analysis of acute and long-term safety as well as therapy outcomes of the ABSORB (trade mark) bioresorbable vascular scaffold system in patients suffering from coronary artery disease.

The register collects prospective data regarding the quality of care of this therapy concept including specifically the following objectives:

* Documentation of all consecutive patients having been treated with the ABSORB biore-sorbable vascular scaffold system under clinical real-world conditions
* Documentation of indications, procedural results, and short and long-term outcomes
* Documentation of the technical performance of ABSORB implant procedures
* Collection of safety data, in particular documentation of hospital mortality, major non-fatal complications (especially myocardial infarction, Re-PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting), stroke, thrombosis)
* Documentation of long-term patient safety marked by mortality and major non-fatal complications (especially myocardial infarction, Re-PCI or CABG, stroke, thrombosis) at 30 days, 6 months, 2 years and 5 years
* Gathering of health economics data (capture of direct costs, especially with view to change of medication and outpatient/inpatient hospital services, and indirect costs) pre and post ABSORB implant
* Gathering data on the quality of life pre and post ABSORB implant to document individual QoL dimensions as well as QALY (quality adjusted life year) data

Eligibility Criteria:
Inclusion Criteria:

* ABSORB implant scheduled
* Age 18+
* Patients giving consent to keep scheduled follow-ups
* Signed informed consent

Exclusion Criteria:

* None
Surveillance of Humira in Korean JIA Patients

Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, underlying diseases and complications especially in regard to purified protein derivative (PPD) skin test, and chest X-ray. At routine visits for Humira Injection administration, which will occur according to usual medical practice, concomitant medication information and adverse events information will be collected for up to 70 days after the last administration of Humira.


Eligibility Criteria:
Inclusion Criteria:

* Patients from 2 years of age who were diagnosed with polyarticular juvenile idiopathic arthritis (JIA) or patients from 6 years of age who were diagnosed with enthesitis-related arthritis (ERA).
* Polyarticular juvenile idiopathic arthritis (JIA) patients for whom the response to previous disease-modifying anti rheumatic drug therapy has been inadequate
* Patients who give written authorization form to use their personal and health data from legal parents or representative.
* Physician will refer to the product market authorization (label) for inclusion criteria.

Exclusion Criteria:

* Patients with known hypersensitivity to Humira or any of its excipients.
* Patients who is participating on other clinical trials.
* Physician will refer to the product market authorization (label) for exclusion criteria.
Accessory Joint and Neural Mobilizations in Shoulder After Breast Cancer Surgery. Randomized Clinical Trial.

The potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. Global kinesitherapy has been shown to be effective at increasing shoulder range of motion restriction. However, literature does not consider specific manual therapy techniques, which means peripheral nerves and articular capsule have not been taken into account. These two tissues are potentially damaged structures during surgery and they are main responsible for shoulder range of motion restriction The main objective of this study is to pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the articular capsule and nerve dysfunctions involvement in shoulder motion restriction.

Background: The potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. Design: Prospective randomized and double-blind pilot trial. Objective: To pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the joint capsule and nerve involvement in shoulder motion restriction. Participants: 18 women who were undergoing unilateral breast cancer surgery and axillary lymph node dissection. Setting: Women´s Health Research Group at Physical Therapy Department of University of Alcala, Madrid, Spain. Intervention: accessory joint mobilization versus neural mobilization. Follow-up: Six-month follow-up. Key outcomes: Range of motion, sensitive disorder, pain and upper limb functionality.

Eligibility Criteria:
Inclusion Criteria:

* unilateral breast cancer diagnosis
* breast cancer with axillary lymph node dissection
* be willing to sign the informed consent form

Exclusion Criteria:

* bilateral breast cancer diagnosis
* loco-regional recurrence
* systemic disease
* had not undergone the axillary lymph node dissection approach
* to present any contraindication for Physical Therapy.
A Study of Imaging in Demyelinating Diseases

This purpose of this study is research the usefulness of MRI with PET/CT imaging for measuring brain inflammation and its relation to Multiple Sclerosis (MS).


Eligibility Criteria:
Inclusion Criteria:

* Meet the requirements for one of the case or control groups.
* MS patients undergoing neurologic evaluation procedures as part of Understanding Sex Differences in Multiple Sclerosis Spectrum of Demyelinating Disorders (IRB# 19-002807) Study or the Mayo Clinic Neurology Multiple Sclerosis Clinic.
* Control participants without inflammatory-demyelinating diseases of the central nervous system
* Capacity to sign consent.

Exclusion Criteria:

* Participants unable to lie down without moving for 20 minutes.
* Women who are pregnant or cannot stop breast feeding for 24 hours.
* For all patients and controls, any acute glucocorticoid (e.g., IV methylprednisolone or PO prednisolone) use within 2 weeks is an exclusion to limit medication interaction but preserve possible chronic systemic inflammation interaction with microglia activation metrics. Chronic disease modifying treatments in MS are allowed as these medications are not known to impact microglia activation.
* Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc., since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.
Lung Cancer Surgery in Sarcopenia Patients With Old Age

The presence of sarcopenia before lung resection surgery might be an important factor of short-term and long-term prognosis in lung cancer patients. Through this study, investigators plan to demonstrate evidence whether sarcopenia is a useful clinical biomarker for risk stratification in elderly patients undergoing lung cancer surgery.

Sarcopenia is a syndrome characterized by a decrease in the amount and function of skeletal muscle, and is known to have a prevalence of about 6-10% in 65 years of age or older and about 20-25% in 70 years of age or older. Recently, many studies have been conducted on the clinical importance of sarcopenia, and it has been reported that sarcopenia is significantly associated with a decline in quality of life and physical activity in the elderly population, as well as harmful clinical outcomes in postoperative patients and poor long-term outcomes in various solid cancer patients. Due to the promising result of lung cancer screening trial, lung cancer has been included in national cancer screening in South Korea since last year. As a result, more people are being diagnosed with lung cancer early. Furthermore, the number of patients having surgical resection for lung cancer is steadily growing, and as life expectancy rises, even older patients are increasingly considering surgical treatment. It's critical to appropriately assess risk in older individuals before and after surgery, and sarcopenia is considered a significant fartor for major surgery. According to studies on the association between sarcopenia and the postoperative clinical outcome of lung cancer surgery, sarcopenia evaluated by computed tomography has demonstrated to be associated with a poor surgical outcome and long-term prognosis. However, according to two recognized guidelines for sarcopenia (European Working Group on Sarcopenia in Elder People, and Asian Working Group for Sarcopenia), sarcopenia is supposed to comprehensively evaluate muscle mass, muscle strength, and physical activity. Regarding muscle mass, it is recommended to measure through dual energy-ray absoptiometery or bioelectrial impedance analysis. However, so far, there are no studies that have conducted an accurate evaluation of sarcopenia in elderly lung cancer patients and analyzed the relationship between them and the clinical outcome after lung cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients planning to perform curative surgery for confirmed lung cancer and pulmonary nodules suspected for lung cancer
* Patients or legal representatives who could understand and write written consent prior to the initiation of the clinical trial and are able to comply with the requirements for the clinical trial

Exclusion Criteria:

* Patients with treatment history for lung cancer or other solid cancer within 5 years (except patients with adenocarcinoma in situ for lung cancer)
* Patients who need simultaneous surgery with lung caner surgery for other accompanying diseases
* Patients who are not eligible to participate in the study judged by the researcher
Study on Prevalence and Impact of Brain Metastases on Survival in Lung Cancer by Line of Treatment

This study will use real-world data to assess prevalence of brain metastases in metastatic non-small cell lung cancer (mNSCLC) patients and its impact on associated clinical outcomes.

This retrospective cohort database study will generate real-world evidence describing prevalence of brain metastases at metastatic diagnosis and by line of therapy, patient characteristics, treatment patterns, and clinical outcomes in metastatic non-small cell lung cancer (mNSCLC) patients

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of mNSCLC in study period (01/01/2015-06/30/2023) including newly diagnosed at metastatic stage or progression from advanced stage NSCLC
2. Age 18+ years at the time of diagnosis of mNSCLC

   Additional inclusion criteria for 1st Line of Therapy cohort:
3. Treated with systemic anti-cancer therapy in 1L setting

   Additional inclusion criteria for 2nd Line of Therapy and 3rd Line of Therapy cohorts:
4. Treated with systemic anti-cancer therapy in 2L setting treated with systemic anti-cancer therapy in 3L setting

Exclusion Criteria:

1. Evidence of other primary malignancy in the 365-day baseline period immediately prior to the first mNSCLC diagnosis in the study period
2. Evidence of stereotactic radiosurgery (SRS), stereotactic radiation therapy (SRT), or whole brain radiotherapy (WBRT) in the baseline period
New Pre-Surgical Scoring System for Uterine Septum

Comparing surgical outcomes of Hysteroscopic metroplasty for uterine septum when using the standard ESGE or ASRM classifications vs the novel scoring system dubbed Shawki Septum Scoring System.

Outcomes based primarily on completion of the septal correction (no residual parts) and avoiding complications, the most significant of which are uterine perforation.


Eligibility Criteria:
Inclusion Criteria:

* Uterine Septum diagnosed by 3D ultrasound

Exclusion Criteria:

-
Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.

The overall clinical development strategy of this project is to conduct this Phase I dose escalation study entitled "A Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients with Recent Intracerebral Hemorrhage". This study will be performed under this current IND application and will be limited to the proposed 12 subjects (3 IV and 1 IT dose groups).

In this application the investigators are proposing to evaluate safety and feasibility of allogeneic, bone marrow (BM) derived mesenchymal stem cells (MSC) to induce neuroregeneration, improve neurological function and alleviate inflammation.

Eligibility Criteria:
* Age range: 18 years or older
* Gender: Male or female
* Acute spontaneous supratentorial ICH documented by head CT with ICH Score between 2 - 4 inclusive
* Stable ICH hematoma volume 60mL or less as measured by ABC2 method by 24-72hrs
* Ability to be enrolled within 72 hours of onset of stroke symptoms
* Ability to provide written personal or surrogate consent. Only subjects who have signed the ICF will be enrolled into the study. The ICF will include elements required by Mayo IRB and FDA in US 21CFR50.
* Subject must have adequate renal function; creatinine \<1.5g/dl.
* Subject must be available for all specified assessments at the study site through the completion of the study.
* Subject must provide written ICF and authorization for use of and disclosure of PHI.
Predisposing Factors for the Incidence of Adrenal Crisis

Within this clinical study patients with chronic adrenal insufficiency will be investigated by clinical and biochemical examination as well as questionnaire to identify predisposing factors for adrenal crisis.

Patients with chronic adrenal insufficiency (AI) are at risk of suffering from life-threatening adrenal crisis (AC), despite established hormone replacement therapies and patient education. Recent retrospective analyses observed different risk factors for AC, e.g. primary AI and comorbidities. Furthermore, patients that already experienced an AC seem to have an increased risk to develop further AC. The aim of the study is to evaluate potential risk factors/predisposing factors for AC in patients with chronic primary and secondary AI (PAI/SAI). Patients with chronic AI are assessed by clinical and biochemical examination and questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor. AI patients with a high frequency of AC will be compared to matched controls (age, sex and cause of AI) with no AC or a low frequency of AC in the past.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patient´s written informed consent
* Ability to comply with the protocol procedures
* Patients with chronic primary or secondary adrenal insufficiency under established stable replacement therapy (disease duration at least 2 years)

Exclusion Criteria:

* Age \<18 years
* Pregnancy or breast feeding
* Intake of CYP3A4-inducting-drugs
The Effects of 5G Radiation on Skin

The current 5G waves used on the daily life are ranging from 410 MHz to 7125 MHz and are called FR1. The next deployed 5G waves will be FR2, from 24.45 GHz to 52.6 GHz. Our project targets the 27.5 GHz frequency, as it will be used in both Europe and the USA. Recent studies have shown that these 5G FR2 waves enter the skin but do not penetrate deeper in the body, which is why our project focuses on the skin.

Our aim is to understand the effects of 5G waves on skin by performing a clinical trial. In this study, participants (healthy volunteers, patients with dermatoporosis, or whose skin is prone to developing cancer or who suffer from atopic dermatitis) will be exposed to carefully chosen 5G parameters and skin will be analyzed by state-of-the-art single cell RNA analysis (an unbiased and very sensitive technique ideal for studying cell behavior changes). This project will also decipher the differences between women and men, in response to 5G FR2 waves.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be recruited in accordance with European and Swiss standards for the following groups: Healtyh volunteers or Dermatoporosis defined as a chronic skin fragility syndrome orGorlin Goltz Syndrome defined as OMIM 10940014, or Familial Cylindromatosis or SB Syndrome defined as OMIM 132700/60504114, or XPV defined as OMIM 27875014 or Atopic dermatitis defined as a chronic inflammatory skin disease characterised by eczematous skin lesions and intense pruritus
* Able to give informed consent as documented by signature,
* Adults, from 18 to 80 yo, according to groups

Exclusion Criteria:

* Recent intense exposure to sun (defined as causing a sunburn, within the last 7 days)
* Pregnant (excluded with a pregnancy test) or lactating women,
* Patients taking anti-coagulants
* Clinically significant concomitant diseases (cutaneous exam by the specialist),
* Active enrolment in another clinical trial,
* Participants incapable of judgment or participants under tutelage.
POWERPLAY: Promoting Men's Health at Work

With funding from the Candian Cancer Society, the Men's Healthy Eating Active Living (MHEAL) project began the development, evaluation, and optimization of a program called POWERPLAY to promote men's health at work.

The MHEAL project began November 2013 and a program (called "POWERPLAY") was developed to support men's active living and healthy eating based on a systematic review of the literature and consultations with groups of men. From 2014-2017 six male-dominated worksites in northern BC offered POWERPLAY and participated in this study. Using a quasi-experimental pre-post design as well as interviews with worksite leads, the program was demonstrated to be an effective, feasible, and acceptable approach to the promotion of modifiable behaviours known to reduce the risk of cancer among working men in northern settings, and several manuscripts were published. Furthermore, the POWERPLAY program was optimized based on feedback received to include friendly competitions, weekly motivational messages, men-friendly language/images, and pedometers, and a manual for employers and website were developed (http://www.powerplayatwork.com/). A new module to support mental well-being was created in 2017 based on a systematic review of the literature for men's mental wellness programs, consultations with men working in northern workplaces, and interviews with workplace representatives. A module to support smoking cessation module was created in 2018.

Eligibility Criteria:
Inclusion Criteria:

Men employed in participating workplaces, full-time or part-time, in any position within the organization

Exclusion Criteria:

Although females were not discouraged from participating in the POWERPLAY program, they were not included in the evaluation.