cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration

This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years at Screening.
* Male or female:

  * Male: A male patient must agree to use contraception as defined in this protocol during the treatment period and for at least 4 weeks after the last dose of study treatment.
  * Female: A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

    1. Not a woman of childbearing potential (WOCBP), OR
    2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Willingness and ability to undertake all scheduled visits and assessments.
* Newly diagnosed choroidal neovascularization (CNV) lesion secondary to wet AMD

Exclusion Criteria:

Patients are not eligible for the study if any of the following criteria apply:

* Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.
* Study eye requiring immediate treatment.
* Any prior treatment with VEGF agent or any investigational products to treat AMD in either eye.
* Uncontrolled ocular hypertension or glaucoma in the SE (defined as intraocular pressure \[IOP\] ≥ 30 mmHg, despite treatment with anti-glaucomatous medication).
* Ocular disorders in the SE (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on VA) at the time of screening that may confound interpretation of study results and compromise VA.
* Any concurrent intraocular condition in the SE (e.g. glaucoma, cataract, or diabetic retinopathy) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.
* Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half lives from randomization, whichever is longer.
* Any type of advanced, severe, or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
* Stroke or myocardial infarction within 6 months prior to randomization.
* Known hypersensitivity to the IMP (aflibercept or any component of the aflibercept formulation) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation.
HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol

To determine whether high-flow nasal cannula oxygen can reduce the incidence of hypoxia during the procedure of sedated hysteroscopy.


Eligibility Criteria:
Inclusion Criteria:

1. 20 years old ≤ age ≤ 50 years old, female.
2. Undergoing hysteroscopy sedated with propofol for diagnosis or treatment.
3. Informed consent
4. BMI≤28kg/m2.
5. ASA physical status Ⅰ\~ Ⅱ.

Exclusion Criteria:

1. Epistaxis, nasal congestion and nasal mucosal damage.
2. Confirmed brain disease (cranial trauma, tumor, stroke, cognitive dysfunction etc.).
3. Confirmed severe heart disease (heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.).
4. Confirmed severe lung diseases (upper respiratory tract infection, asthma, bronchitis, COPD, bullae, pulmonary embolism, pulmonary edema, lung cancer, etc.).
5. Pregnant women.
6. Acute and chronic hepatitis or liver cirrhosis with severe abnormal liver function.
7. Acute and chronic nephritis with severe abnormal renal function or renal failure.
8. Needing oxygen inhalation for underlying diseases.
9. Emergency surgery.
10. Combined with multiple trauma.
11. Allergic to soybean
Identification and Preservation of Arm Lymphatics

Controversy in axillary reverse mapping in axillary lymph node dissection (ALND) possibly results from incomplete recognition of the arm lymphatic system (ALS) and its compromise to oncological safety. The iDEntification and Preservation of ARm lymphaTics (DEPART) technique facilitates complete identification of ALS; therefore, its use may decrease the occurrence of arm lymphedema. This study aimed to examine the arm lymphedema rate, locoregional recurrence, and feasibility to perform DEPART in ALND.

In the study group, indocyanine green and methylene blue (MB) were utilized to identify arm sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive. Arm lymphedema, local recurrence, regional recurrence, and distant metastasis were recorded at different follow-up examinations.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older with T1-3 invasive breast cancer;
* Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast;
* Patients who underwent mastectomy with a positive sentinel lymph node (SLN);
* Patients who underwent breast-conserving surgery containing more than two positive SLNs.

Exclusion Criteria:

* Neoadjuvant chemotherapy;
* Previous history of breast cancer.
Comparison of Virtual Reality and Podcast in Improving Patient Experience During Colposcopy

This study wants to see if two things-virtual reality (VR) and podcasts-can help women feel better during a medical test called colposcopy. The study looks at stress, anxiety, pain, and heartbeat. It also checks if women are happy with the test and how long the test takes.

There are three groups: one uses VR, one listens to a podcast, and one gets no extra help.

The study will include 75 women in Turkey. All women are 25 to 65 years old and need to have a colposcopy.

Some women cannot join the study-for example, if they are pregnant, cannot see or hear well, or take strong medicine for pain or stress.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for colposcopy procedure due to suspicion of cervical squamous intraepithelial lesions.
* Individuals who agree to sign the informed consent form and are willing to participate after being informed about the procedure.
* Individuals who are deemed suitable for the colposcopy procedure and whose health status does not constitute an obstacle to perform this procedure (no visual or hearing impairment).
* Volunteers who speak Turkish at a level to understand the methods and questionnaires used in the study.

Exclusion Criteria:

* Those with claustrophobia, epilepsy, or any other neurological or psychological disorder that may cause discomfort when using the VR headset.
* Individuals with hearing loss that affects their ability to hear podcast content.
* Individuals with vision loss that affects their ability to see VR content.
* Individuals who have previously experienced discomfort while using VR or are unable to adapt to VR
* Individuals who are not suitable for the colposcopy procedure or have a serious health condition that may affect the procedure
* Individuals who are pregnant.
* Individuals with language barriers who may have difficulty understanding the study procedures or distractions.
* Individuals with regular use of sedative or pain medication that may affect stress or pain management during the study.
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* A male or female between 18 and 40 years of age, inclusive, at the time of first vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects as established by medical history, clinical examination and laboratory assessment before entering into the study.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:

  * has practiced adequate contraception for 30 days prior to vaccination, and
  * has a negative pregnancy test at Screening, and
  * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
* Any clinically significant acute or chronic, local or systemic infection, proven or suspected to be caused by Staphylococcus aureus and requiring antibiotic treatment, within the 6 months preceding the first vaccination.
* Previous administration of any investigational Staphylococcus aureus vaccine/antibodies.
* History of; or current bleeding or coagulation disorder.
* Known or suspected reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* History of; or current autoimmune or other immune-mediated disease.
* Administration or planned administration, of any vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines up to 1 month after the last vaccine dose.
* Administration of immunoglobulins and/or any blood products within the last 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* Any clinically relevant abnormal haematological or biochemical or urine laboratory values at screening.
* Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
* Acute disease and/or fever at study entry.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* History of; or current alcoholism and/or drug abuse.
* Any other condition that the principal investigator judges may interfere with study findings.
Open Surgery for Necrotizing Pancreatitis

Retrospective analysis of the cases of traditional open surgery for acute necrotizing pancreatitis, with evaluation of indications for surgery, intraoperative findings, mortality rate and risk factors of mortality.

All cases of laparotomy/lumbotomy will be retrospectively analysed, with evaluation of mortality, complications, in-hospital stay, indications for surgery, findings during operation, combination with minimally invasive procedures (radiological drainage, necrosectomy). Assessment of risk factors, like erosive bleeding, intraperitoneal perforation of collection, gut resection, splenectomy, relaparotomy will be done.

Eligibility Criteria:
Inclusion Criteria:

* laparotomy or lumbotomy performed for acute necrotizing pancreatitis from January, 2008 to December, 2017

Exclusion Criteria:

* N/A
Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin

The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin 25 mg and metformin


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type II diabetes mellitus aged 19 years or older
* Subjects with 7.0%≤HbA1c≤10.5% at screening visit
* Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit

Exclusion Criteria:

* Subjects with type 1 diabetes mellitus or secondary diabetes
* Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit
* Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin)
* Body mass index greater than 40 kg/m2 at the screening visit
* Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment
Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods

The investigators will compare myocard vitality diagnostics using 2D-Strain echography and MRI.

Each patient with typical angina pectoris symptoms will get echocardiographic examination during the inclusion phase. If motion disorder of regional left ventricular myocardial wall is detected, patient will get coronary angiography (not study related, caused of typical angina pectoris symptoms and high probability of CHD). If coronary stenosis related to motion disorder is available, patient will be randomized in two groups during coronary angiography.

* First Group: Patient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of this echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI (Percutaneous Coronary Intervention) will be performed.
* Second Group: Coronary angiography by patient will be canceled. Patients will get viability assessment using MRI(Magnetic resonance imaging) within the next 7 days. When vitality will be established with MRI, patient will get PCI (Percutaneous Coronary Intervention).

In addition, as part of a feasibility analysis, the possibility of a consolidation of data of coronary angiography with the ultrasound images will be researched by first group of patients. The aim is to simplify the visualization of the intraprocedural vitality detection. For this purpose, a position sensor based on electromagnetic fields (EMT) will be used during coronary angiography.

Eligibility Criteria:
Inclusion Criteria:

* Typical angina pectoris symptoms
* Echocardiographic determination of regional motion disfunction of left ventricular wall
* Establishment of needly treatment of stenosis related to motion disorder based on coronar angiography.
* Feasibility of MRI-Examination.
* Patients which are legally competent and which are mentally able to understand the study staff
* Patients give their written consent

Exclusion Criteria:

* Allergy against contrast agent
* Patients with limited renal function(GFR \< 60 ml/min)
* Acute or instable angina pectoris
Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency).

The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.

Bronchiectasis is an airway disease with many etiologies characterized pathologically by the abnormal permanent dilatation of bronchi, caused mainly by the perpetuation of inflammatory processes induced by frequent episodes of bacterial infections, with consequent change in the ciliated epithelial lining and compromising the effectiveness of mucociliary clearance that can favor the hypersecretive state found in these patients.

In addition to drug therapy or surgical treatment, patients with bronchiectasis also have physiotherapy, which is an important part in treatment. The patients present impaired mucus transport, and can enjoy the benefits provided by respiratory therapy, which features intended to increase the removal of airway secretions and thus reduce the obstruction to improve ventilation and oxygenation.

One of the instruments commonly used in respiratory therapy is the Flutter ® VRP1 (VarioRaw SA, Switzerland), which is a simple equipment, small, similar to a pipe that combines two techniques: positive expiratory pressure (PEP) and high-frequency oscillations.

Some previous studies have shown beneficial effects after use of this device in patients with bronchiectasis. However, it is unclear whether the mechanism of action is related to the combination of PEP and the techniques of high frequency oscillation, or just one of those components.

Eligibility Criteria:
Inclusion Criteria:

* Non Cystic Fibrosis Bronchiectasis
* Amount of secretion sufficient for analysis
* Capable of fulfilling the experimental protocol

Exclusion Criteria:

* Acute pulmonary disease
* Presence of any respiratory infection in the last four weeks
Feasibility Evaluation of a Dance Fitness Program

The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD).

The proposed project is a pilot two-arm randomized controlled trial (RCT), with specific aims to evaluate the feasibility and acceptability of implementing an RCT of OULA (named after Missoula, MT) for the treatment of postpartum depression, and to explore between-subject changes in postpartum depression and postpartum anxiety following 8-weeks of OULA or waitlist control.

Eligibility Criteria:
Inclusion Criteria:

* Ages 20-39 years
* Have an infant 0-12 months old
* Self-report clearance from provider to engage in physical activity following birth
* Structured Clinical Interview for Diagnostic Statistical Manual-5-Research Version (SCID-5-RV) diagnosis of major depressive episode (MDE) with onset during pregnancy or 12 months following childbirth
* Edinburgh Postnatal Depression Scale (EPDS) score of 10 or above
* English speaking
* OULA-naïve
* If on first-line treatment for depression; antidepressant dose must be stable for 6 weeks; psychotherapy duration of treatment must be at least 4 weeks

Exclusion Criteria:

* Unable to be physically active
* Current pregnancy
* SCID-5-RV diagnosis of bipolar disorder, schizophrenia, or current substance use disorder
* Active suicidal attempt or plan identified on the SCID-5-RV
* Suicide attempt in the past 6 months
* Concurrent participation in another group dance fitness format
* No access to Internet via computer, tablet, or smart phone
Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

The current study aims to test a brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. In this open trial pilot feasibility study, 20 pregnant women in their first trimester will be invited to participate in the study if they endorse elevated PTSD symptoms. Oxytocin and cortisol will be measured at baseline, one month post-intervention, three months post-intervention, and post-delivery to inform the relationship between these hormones, PTSD symptoms, and peripartum/postpartum outcomes. In addition to receiving the psychoeducation + skills intervention during their first trimester, women will be offered a "booster session" intervention following delivery to enhance utilization of skills during a critical period for maternal mental and physical health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old
* Fluent in English

Exclusion Criteria:

* Active and severe domestic violence
* Evidence of a significant mental illness or current substance use disorder that would impede the completion of the intervention
* Suicidal individuals deemed at immediate danger or risk (i.e., requiring immediate hospitalization or treatment)
* Women who smoke
* Women who have a metabolic or endocrine disorder.
Efficacy of Eltrombopag to Improve Thrombocytopenia of MYH9-related Disease

The term MYH9-related disease (MYH9RD) includes four genetic disorders: May-Hegglin anomaly, Sebastian syndrome, Fechtner syndrome, and Epstein syndrome. All these disorders derive from mutation of a unique gene, named MYH9, and they have been recognized as different clinical presentations of a single illness that was named MYH9RD. All patients affected by MYH9RD present since birth with thrombocytopenia, which can result in a variable degree of bleeding diathesis; some of them subsequently develop additional clinical manifestations, such as renal damage, sensorineural hearing loss, and/or presenile cataracts. Eltrombopag is an oral thrombopoietin receptor agonist that stimulates proliferation and differentiation of megakaryocytes, the bone marrow cells that produce blood platelets. This drug is effective in increasing platelet count in healthy volunteers, as well as in patients affected by some acquired thrombocytopenias, such as idiopathic thrombocytopenic purpura and HCV related thrombocytopenia. The purpose of this study is to determine if eltrombopag, administered orally at the dose of 50 or 75 mg/daily for up to 6 weeks, is effective in increasing platelet count of patients affected by MYH9RD. Further aims of this study are to test if eltrombopag is effective in reducing bleeding tendency of MYH9RD patients; to evaluate safety and tolerability of eltrombopag in patients with MYH9RD; to evaluate in vitro function of platelets produced during therapy in patients responding to this drug.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 years or more
* Confirmed diagnosis of MYH9-related disease
* Average platelet count for the previous year less than 50x10e9/L
* Written informed consent

Exclusion Criteria:

* Diseases known to involve the risk of thromboembolic events (e.g. atrial fibrillation)
* History of thrombosis within 1 year
* Use of drugs that affect platelet function (including but not limited to, aspirin, clopidogrel or NSAIDS) or anti-coagulants
* Females who are pregnant or nursing (a negative pregnancy test in required before enrollment of fertile women)
* Formal refusal of any recommendation of a safe contraception
* Alcohol or drug addiction
* Altered renal function as defined by creatinine of 20 mg/L or more
* Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioral problems. HCV positivity and liver diseases will not be considered an exclusion criterion since a phase II study showed that eltrombopag was effective and safe in this patient population.