cyrilzakka/clinical-trials huggingface dataset:
Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms

The study objective is to evaluate the safety and effectiveness of the MicroVention FRED System when used in the treatment of wide-necked intracranial aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Subject whose age is ≥ 18 years;
* Subject has a single target aneurysm located in the following zones:
* Zone 1 - Petrous through cavernous of the ICA
* Zone 2 - Ophthalmic segment of the ICA
* Zone 3-Posterior Circulation, basilar artery (not including the basilar bifurcation), vertebral artery
* Subjects with a single target intracranial aneurysm located along the internal carotid artery, or the vertebral or basilar artery for whom existing endovascular options (coiling, stent-assisted-coiling) could be ineffective or because aneurysm is predisposed to recurrence due to having any of the following characteristics:
* Aneurysms with a neck \> 4mm, dome to neck ratio ≤2 or no discernible neck
* Fusiform aneurysms of any size requiring treatment;
* The parent artery must have a diameter of 2.5 - 5.0mm distal/proximal to the target intracranial aneurysm (IA);
* Subject fulfills study requirements, and the subject or his/her legally authorized representative provides a signed informed consent form;
* Negative pregnancy test in a female subject who has had menses in the last 24 months;
* Subject is willing to return for the 1-month and 6-month follow-up evaluations

Exclusion Criteria:

* Subject who is pregnant or breastfeeding; Subject who suffers from a subarachnoid hemorrhage in the last 60 days;
* Subject who suffers from any intracranial hemorrhage in the last 30 days;
* Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region;
* Subject with stenosis of the parent artery (\>50%) proximal to the target aneurysm;
* Subject with known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents;
* Subject with contraindications or severe allergies to anticoagulants or antiplatelet medications (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor);
* Subject with known hypersensitivity to metal, such as nickel-titanium and metal jewelry
* Subject with documented contrast allergy, or other condition, that prohibits imaging.
* Evidence of active bacterial infection at the time of treatment;
* Subject who has had a previous intracranial stenting procedure associated with the target aneurysm;
* Subject with life-threatening diseases.
Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support

The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Onset or exacerbation of pneumonia at least 72 hours after admission to an acute care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility
* Diagnosis of hospital-acquired pneumonia requiring mechanical ventilatory support
* Patient or Patient's legal guardian must sign written informed consent for study participation, pretreatment, and Day 7 bronchoscopy

Exclusion Criteria:

* Patients with hospital-acquired pneumonia caused by pathogens resistant to MERREM
* Patients with allergies to cephalosporins, penicillins and carbapenems
* Patients taking anticonvulsant therapy for a known seizure disorder
* Patients with lung cancer
* Patients with cystic fibrosis, acquired immune deficiency syndrome (AIDS), neutropenia, active tuberculosis, or patients taking immunosuppressive therapy in preparation for or following an organ transplant.
* Patients who are pregnant or breast feeding
* Patients who are unlikely to survive
* Patients with certain infections in another area requiring treatment with additional antibiotics
* Patients with other underlying conditions that would make it difficult to interpret response to study drug.
* Patients who have been part of another clinical study 30 days before entry into this study.
* Patients with hypotension (systolic BP \< 85mmHg) or acidosis (arterial pH \<7.25 or serum bicarbonate \<15 mg/dl) despite attempts at fluid resuscitation
* Patients with profound hypoxia
Translation, Cultural Adaptation, Reliability, and Validity of the Turkish Version of the Cervical Radiculopathy Impact Scale

The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Cervical Radiculopathy Impact Scale (CRIS).

Cervical radicular syndrome is a common health problem that causes pain in the arm and / or hand and is accompanied by motor and / or sensory defects. These symptoms often have an intensity that prevents normal function. For individuals with cervical radicular syndrome, there is a lack of a patient-reported outcome measurement tool to measure the impact of the disorder. The Cervical Radiculopathy Impact Scale (CRIS), which focuses on the symptoms and functionality of the arm and neck, was developed to improve the quality of studies on cervical radicular syndrome. CRIS is a newly developed self-report questionnaire that covers the measurement of symptoms and limitations in individuals with cervical radiculopathy due to pain, tingling sensation, and loss of sensation in the arm with neck discomfort. The CRIS consists of 21 items divided into three subscales: (i) symptoms, (ii) energy and postures, and (iii) actions and activities. Each item contains a likert type answer and takes a value between 1 and 5. The study is planned with 105 individuals with hip disease. After questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in CRIS, EQ-5D Health-Related Quality of Life Questionnaire, Neck Disability Index, Quick Disabilities of the Arm Shoulder and Hand, Brief Illness Perception Questionnaire, Short Form-36 and Visual Analog Scale. Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with radiculopathy symptoms and diagnosis.

Exclusion Criteria:

* Having another neck disorder other than radiculopathy,
* History of cervical spine surgery,
* Corticosteroid injection to cervical spine in the past 3 months,
* Having neurological and cognitive disorders.
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis

The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF who lost adequate response to and/or are intolerant to ruxolitinib. Inadequate response definitions will follow Ministry of Food and Drug Safety-approved label and reimbursement criteria of the Health Insurance Review \& Assessment Service.


Eligibility Criteria:
Inclusion Criteria:

* Participants 19 years of age or older
* Participants who will receive fedratinib according to the approved label
* For the first 2 years after marketing authorization, all participants who have received or are receiving fedratinib will also be registered
* Participants who signed the informed consent form

Exclusion Criteria:

* Participants who have been prescribed fedratinib for an indication not approved in Korea
* Participants who have been prescribed fedratinib at a dose not approved in Korea
* Participants for whom fedratinib is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety
Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis

The purpose of this study is to understand better if indoor daylight Photo Dynamic Therapy (PDT) can provide effective lesion clearing versus conventional red lamp light therapy.

Subjects who enroll into this research study, their participation in this study will last up to 6 months. They will be asked to return to the clinic 3-4 times.

Subjects will be randomized into one of two study arms:

Arm 1 - Indoor Daylight PDT Therapy Arm 2 - FDA Approved Standard Light Therapy Treatment

Eligibility Criteria:
Inclusion Criteria:

* All patients with actinic keratosis appearing at the Dermatology Clinic for PDT treatment.
* Age ≥ 18 years older.

Exclusion Criteria:

* Pregnant women or women who are breast-feeding.
* Any patients with a condition that makes them not suitable for clinical PDT.
Clinical Assessment and Psychosocial Impact of Psoriasis

The purpose of this study is to explore the impact of plaque psoriasis on the different dimensions of patient life including psychological disorders, different types of addictions, and their consequences on health-related quality of life and socioeconomic parameters at baseline (cross-sectional part) and during the initial years of the psoriasis disease (longitudinal part).

This is a prospective, non-interventional, observational, multicenter study to document the prevalence of alexithymia in adult men and women, 18 years of age and older, who have had the onset of the first symptoms of plaque psoriasis less than 10 years before study entry, are naïve or experienced to topical treatment, and are eligible for phototherapy or systemic treatment. Only data available from routine clinical practice will be collected and all treatment decisions will be made at the discretion of the treating physician. Additionally, where local regulations permit, participating physicians will be asked to obtain Patient-Reported Outcome (PRO) data from patients participating in this observational study. A target of 800 adult patients will participate in this study at approximately 80 sites. The enrollment period of this study is expected to continue for approximately 9 months. Each patient will receive treatment as per standard clinical practice and will be followed up for 12 months. Therefore, the total duration of this observational study is expected to be approximately 21 months. Overall psoriasis disease severity as assessed by the physician will be documented at baseline (cross-sectional) and in the observational (longitudinal) phase of the study. Several outcomes related to psychosocial comorbidities (eg, alexithymia, anxiety, depression), addiction, and work and activity impairment as measured by PRO questionnaires and scales will also be collected. Information on psoriasis treatment(s) (topical, phototherapy, systemic \[non-biologic, biologic\]), mental health drugs (including those used for sleep), and concomitant medications given for comorbid medical conditions will also be collected. The data for this study will be analyzed and reported separately for the cross-sectional data (baseline) and for the longitudinal data (from baseline to Month 12).

Eligibility Criteria:
Inclusion Criteria:

Have onset of first symptoms of plaque psoriasis less than 10 years before baseline; Be either naïve or experienced to topical treatment; Be eligible for phototherapy or systemic treatment, as determined by the participating physician at the patient's baseline visit.

Exclusion Criteria:

Has a history of or current treatment with a systemic agent (including biologic agents); Has non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular); Has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or first data collection time point.
A Study Of PF-04449913 Administered Alone In Select Solid Tumors

This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of advanced/metastatic solid tumor
* Adequate Bone Marrow Function
* Adequate Renal Function
* Adequate Liver Function

Exclusion Criteria:

* Patients with known symptomatic brain metastases requiring steroids
* Current active treatment on another clinical trial
* Major surgery or radiation therapy within 4-weeks of starting study treatment
Telecare in Rural Senior Centers

The objective of this project is to assess the feasibility of telehealth stations at community centers as a mechanism to increase healthcare access for older adults living in rural communities.


Eligibility Criteria:
Inclusion Criteria:

* Age of 21 years or older
* Independently capable to complete electronic survey form
* Cognitive capable to verbalize consent for semi-structured interview

Exclusion Criteria

- Unable to complete an electronic survey form
Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients

This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation.


Eligibility Criteria:
Key Inclusion Criteria:

* Male patients, and female patients of non-childbearing potential, age ≥ 18 to ≤ 75 years (at the time of the screening visit), and in general good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
* Patients with at least five clinically typical, visible or palpable non-hyperkeratotic AK lesions within a contiguous area of 25 cm2, or within 2 areas for a maximum total of 25cm2, on the face (at least 2 cm from the periocular areas, lips, nares and ears) and/or balding scalp
* Presence of at least one additional visible or palpable non hyperkeratotic AK lesion outside of the selected area amenable to the collection of a skin biopsy, and located at least at 2 cm from the limits of the area to receive treatment
* Male patients had to agree to use adequate contraception for the duration of the study.

Key Exclusion Criteria:

* Known hypersensitivity to any constituents of the study drugs (including local anesthetics if consenting to biopsies) or known allergies to imiquimod or to drugs of similar chemical classes or history of serious allergic reaction.
* Presence of atopic dermatitis, eczema, psoriasis, rosacea or other possible confounding skin conditions on face or balding scalp even outside of the treatment area.
* Invasive tumors within the treatment area, e.g., merkel cell carcinoma, melanoma, squamous cell carcinoma (SCC), basal cell carcinoma, the latter being accepted if completely surgically removed.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
* History of hypertrophic scarring.
* Concurrent disease that suppresses the immune system.
A Pilot Study of a 14-day Modified Sequential Therapy for Helicobacter Pylori Infection

The purpose of this study is to assess efficacy of a new 14-day sequential therapy for the rescue treatment of refractory Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates. The researchers also want to testify whether a double-dose rabeprazole has equal efficacy to double-dose esomeprazole to provide sufficient acid inhibition.

Half of the world's population is infected with Helicobacter pylori. Strong evidence supports that H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly emerging antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted. Traditional sequential therapy failed to achieve an ideal eradication rates (over\>95%) as a third line treatment in the region with high antibiotic resistance. This study aims to evaluate the efficacy of 14-day modified sequential therapy in the patients with two or more treatment failure, and whether the adverse effects of this new modified sequential therapy are tolerable. Then, this study will also compare the performance of a double-dose esomeprazole with double-dose rabeprazole containing therapy to optimize therapeutic regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 with persistent H. pylori infection.
* Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

Exclusion Criteria:

* Patients unable or unwilling to receive gastroscopy.
* Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
* History of allergy to any of the drugs used in the study.
* Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
* Currently pregnant or lactating.
* Severe neurologic or psychiatric disorders.
* Alcohol abuse or drug addiction.
* Patients with compliance lower than 90% in any previous treatment are not included.
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Use of G-CSF Supplemented IVF Medium in Patients Undergoing IVF

The purpose of this study is to determine whether in Assisted Reproductive Technologies the use of culture medium supplemented with G-CSF, a growth factor working on stem cells, may improve the embryo implantation and pregnancy rate in infertile patients undergoing IVF cycles.

In Assisted Reproductive Technologies the rate of pregnancy for cycle and the implantation rate remain low nevertheless the improvement in the last years. In particular also in relatively young reproductive age women nevertheless the good embryos produced and transferred pregnancy rate and implantation rate remain low. Recently, it has been showed that culture medium supplemented with G-CSF, may improve the embryo outcomes in IVF. In this trial the investigators will test the potential benefits of this culture medium on embryos of patients undergoing IVF. 180 infertile women undergoing IVF no more than 37 years old will be selected. These patients will be assigned to two arms, one experimental and one other of control by a computer generated sequence. After the oocyte retrieval and fertilization by ICSI procedure, the fertilised oocyte (2PN)will cultured with the G-CSF supplemented culture medium or in normal culture in micro drop of 30microliters under oil until the day of transfer (day five or blastocyst sage embryos). A maximum of two embryos will be transferred. The pregnancy rate, implantation rate and number of blastocyst developped will be the outcomes considered

Eligibility Criteria:
Inclusion Criteria:

* infertility
* healthy condition,
* good ovarian reserve (AMH levels more than 1microg/ml)

Exclusion Criteria:

* chromosomal defects in the couple,
* metabolic diseases (diabetes, etc),
* other genetic diseases (thalassemia, cystic fibrosis, etc.)
CD19/CD20 Dual-CAR-T in B-cell Lymphoma Patients

This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell lymphoma.

This Phase I study is designed as a pilot trial evaluating the safety and efficacy of CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B cell lymphoma. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD20 Dual-CAR-T cells. Safety and efficacy of CD19/CD20 Dual-CAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19/CD20 Dual-CAR-T cells therapy in patients with refractory and relapsed B-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed and refractory B-cell lymphoma with:

   Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed after autologous or allogeneic hematopoietic stem cell transplantation (ASCT);
2. Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
3. Double positive expression of CD19 / CD20 in B cells;
4. Ages 1 to 80 years, including boundary values;
5. ECOG score 0-3 points;
6. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside;
7. Patients who voluntarily sign informed consent and are willing to comply with treatment plans.

Exclusion Criteria:

1. patients with organ failure:

   * Heart: NYHA heart function grade IV;
   * Liver: Grade C that achieves Child-Turcotte liver function grading;
   * Kidney: kidney failure and uremia;
   * Lung: symptoms of respiratory failure;
   * Brain: a person with a disability;
2. Active infections that are difficult to control;
3. Human immunodeficiency virus (HIV) positive;
4. Liver and kidney function: total bilirubin \> 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 5 × ULN, serum creatinine clearance rate 60mL / min;
5. GVHD ≥ 2 or anti-GVHD treatment;
6. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
7. pregnant or lactating women;
8. The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
9. Patients who participate in other clinical studies at the same time;
10. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis

Patients diagnosed with Behcet's disease will be randomized to administeration of hydroxychloroquine. Assessment will be done for the patients at baseline and every one month in the first three months and then quarterly for one year.


Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with Behcet's disease on any DMARDs

Exclusion Criteria:

* Patients with critical conditions
* Patients with hypersensitivity or adverse drug reactions to hydroxychloroquine.