cyrilzakka/clinical-trials huggingface dataset:
Treatment of Coronary In-Stent Restenosis

The purpose of this study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus.

In-stent restenosis after coronary angioplasty is currently one of the main limitations of this method, leading to a recurrence of exertional angina pectoris or manifesting as acute coronary syndrome. Histopathologic substrate of in-stent restenosis is neointimal hyperplasia.

Repeated plain balloon angioplasty or using cutting balloon catheters in the treatment of in-stent restenosis does not achieve satisfactory results. Brachytherapy, used in the past, it has also abandoned. The current treatment of in-stent restenosis is the use of drug eluting stents. Local drug released from these stents prevents new neointimal hyperplasia.This treatment carries the risk of late thrombosis (due to delayed neoendotelization) the stent struts and requires rigorous long-term dual antiplatelet therapy with the risk of bleeding complications. The drug-coated balloon catheters provide short-term penetration of the active substance into the vascular wall, leading to the inhibition of hyperproliferation vascular smooth muscle cells, but due to short-term effect they do not affect negatively stent struts neoendotelization. Comparable effects of in-stent restenosis therapy using paclitaxel releasing balloons was demonstrated in comparison with paclitaxel releasing stents, however, the development of drug eluting stents meanwhile progressed. The aim of our study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus. Primary endpoint of our study is late lumen loss, because it represents accurate angiographic parameter predicting the need for repeat revascularisation and thus the clinical benefit for the patient.

The 3rd observational, non-randomised arm compares the treatment with seal-wing paclitaxel-eluting balloon with two randomised arms (PEB vs. EES).

3-year long term clinical follow-up of iopromide-coated PEB and EES arms was performed. All clinical MACE (CV death, AMI and TVR) were recorded.

Subanalysis of seal-wing PEB arm comparrng the treatment of BMS and DES-ISR was added.

Eligibility Criteria:
Inclusion Criteria:

* history of percutaneous coronary intervention with stent placement
* verified coronary in-stent restenosis suitable for percutaneous re-intervention
* signed informed consent

Exclusion Criteria:

* contraindication to long term dual antiplatelet therapy
* increased risk of bleeding
* known generalized malignancy
* pregnancy
Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)

The investigators are investigating whether home-based tDCS over the course of four weeks can improve ADHD symptom severity and improve dysexecutive functioning (cognitive control). Further, the investigators are investigating whether there is a dose-dependent response to tDCS.

This mechanistic clinical trial will be the first of its kind to assess the clinical and cognitive efficacy of tDCS, and its relationship to physiological target engagement. It will also provide critical knowledge about tDCS dosing in a therapeutic context (i.e. 30 days of daily tDCS). Last, it will assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD. An additional goal of the proposed study is to assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female outpatients 18-65 years of age
2. A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

Exclusion Criteria:

1. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
2. Active substance dependence (except for tobacco).
3. Pregnant or nursing females.
4. Inability to participate in testing procedures.
5. Premorbid neurological conditions (including neurovascular and neurodegenerative diseases such as traumatic brain injury, stroke, Parkinson's, AD and other dementias) and severe psychiatric disorders (bipolar disorder, schizophrenia).
DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with open angle glaucoma or ocular hypertension
* Provided signed, written informed consent
* 20 years of age and older
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.
Trends in the Epidemiology and Treatment of Atopic Dermatitis in the United Kingdom (UK)

Atopic dermatitis, commonly called eczema, is one of the most frequently occurring skin conditions. It is estimated to affect around one fifth of children in developed countries and is also becoming increasingly common in less developed countries. Exact estimates of how common eczema is, vary considerably and there has not been an in-depth analysis of the number of people with eczema in the UK. It is also unclear which groups of people are most affected and which treatment options are being used.

Most people with eczema are managed by their general practitioner (GP) with only a few people requiring specialist care. GP records therefore provide an excellent opportunity to explore how common eczema is and which treatments are being used currently. This study aims to provide accurate estimates of the number of people with current eczema (prevalence), number developing new onset eczema (incidence), and the pattern of common comorbidities in people with eczema. It also aims describe current treatment patterns by age groups and other factors. It also will look back over the last decade to identify how the number of people with eczema and treatments changing over time. The study will also explore patterns in the people most commonly affected and in the treatments used.

Objective

This study aims to calculate current and accurate prevalence and incidence estimates for atopic dermatitis (AD) by age group and sociodemographic factors. It also aims to describe the burden of comorbidity in AD with a focus on atopic and mental health conditions. The study also aims to describe the health care resource utilisation of this cohort in terms of prescription use, primary care appointments, and specialist referrals.

Method This study will define AD cases using a previously validated algorithm for case identification use clinical codes form primary care in the UK (Read codes). The study will analyse the population prevalence and incidence of AD using this definition over a 10-year period (2008-2018). Within this population the prevalence of autoimmune conditions (rheumatoid arthritis, inflammatory bowel disease, coeliac disease, type 1 diabetes, and multiple sclerosis) will be reported and compared with a cohort of individuals without a diagnosis of AD, matched by age and sex at GP practice level. In the same cohort, the annual use of topical and oral medications used for the treatment of AD, primary care appointments, and specialist referrals, overall and stratified by sociodemographic factors will also be reported.

Eligibility Criteria:
Inclusion Criteria:

* All paediatric and adult patients registered with an Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) contributing GP practice during the study period (2008-2018) and with at least one year of follow-up.

Exclusion Criteria:

* The presence of psoriasis, photodermatitis, or ichthyosis
Effects of Sulforaphane on Normal Prostate Tissue

The investigators proposed to identify the biological effects of a high-sulforaphane broccoli sprout extract in normal prostate tissue.

The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract every other day will inhibit growth of prostate cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 40-75 years
* Low or intermediate grade prostate cancer (as defined by Gleason sum less than or equal to 7) and clinical stage T1 or T2
* Serum Prostate specific antigen less than 20 ng/ml
* Have elected radical prostatectomy, Brachytherapy or active surveillance as their primary treatment

Exclusion Criteria:

* No current physician diagnosed disease (including but not limited to): kidney disease requiring dialysis, cognitive deficits, substance abuse
* BMI \< 18.5 kg/m2 or \> 40 kg/m2
* Use of any hormonal treatments, including but not limited to testosterone
* Any previous cancer diagnosis or treatment within the previous five years, excluding non-melanoma skin cancer
* Inability or unwillingness to eat a diet that is free of Brassica vegetables for the duration of the study
* Use of any dietary supplements other than a multivitamin (including herbal preparations)
* Allergy to cruciferous vegetables or any of the specific fillers used in the placebo
* Usual consumption of \> 5 servings per week of Brassica vegetables
Personalized rTMS for Resistant Depression

The investigators hypothesize that personalizing the rTMS targets using functional MRI will increase its efficacy. The most dysfunctional regions or the most dysfunctional network will be stimulated homogeneously. Individualized rTMS will be compared to traditional rTMS procedure and to trans-cranial direct current stimulation (tDCS) in a randomized cross-over trial.

In this pilot study the primary outcome measure will be the correction of the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary outcome measurements.


Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 65 Y
* Affiliated to the health insurance
* Having signed an informed consent
* Suffering from major depression according to the DSM5
* Unresponsive or incomplete remission after at least one trial of antidepressant (\> 6 weeks at efficient dose or side effects)
* Treatment stable for \> 6 weeks

Exclusion Criteria:

* Contraindication for MRI, rTMS or tDCS: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tDCS electrode placement.
* Pregnancy
* Severe and non-stabilized somatic pathology
* Patients deprived of liberty or hospitalized without their consent
Crohn's Disease - Inflammation and Microbial Proteolytic Activity

This study postulates that altered microbiota associated with areas of mucosal inflammation in CD, can be characterized by an increased proteolytic profile. This is clinically important as it may be possible to modulate the proteolytic activity of the CD-associated bacteria by using other bacteria that produce protease inhibitors, such as serpins.

Crohn's disease (CD), characterized by discontinuous intestinal injury and inflammation, has been associated with changes in the luminal microbiota and impaired barrier function. Previously, the investigators have shown that in patients with CD, the mucosa-associated microbiota is altered. Additionally, it has been shown that in patients with active CD, areas of intestinal injury are associated with impaired barrier function, but the mechanisms remain unclear. Increased host proteolytic activity has been reported in both CD and ulcerative colitis (UC). The microbiota is an important source of proteases with potential inflammatory and barrier disrupting capacity. Indeed, preliminary data indicate that in UC patients the gut microbiota contributes to proteolytic imbalance. It is unknown whether this is also the case in CD. Specifically, this study postulates that the altered microbiota associated with areas of mucosal inflammation in CD, is characterized by an increased proteolytic profile. This is clinically important as it may be possible to modulate the proteolytic activity of the CD-associated bacteria by using other bacteria that produce protease inhibitors such as serpins.

In this prospective observational study, patients booked for routine white light colonoscopy under the care of the Division of Gastroenterology, Hamilton Health Sciences at the McMaster University Medical Centre and Juravinski Hospital Endoscopy Units will be invited to participate. Patients previously diagnosed with Crohn's disease who have a clinical indication for undergoing a standard white light colonoscopy, as determined by the gastroenterologist, will be invited to participate; biopsy samples and mucosal brushings will be taken from inflamed and non-inflamed areas in the ileum or colon.

Eligibility Criteria:
Inclusion Criteria:

* Be aged between 18 - 70 years old
* Have a confirmed diagnosis of Crohn's disease
* Have a clinical indication for standard, white light colonoscopy to assess disease activity and extent

Exclusion Criteria:

* Inability to provide written informed consent
* Presence of serious life-threatening co-morbidities
* Evidence of toxic megacolon, jaundice, cirrhosis, renal dysfunction, acute GI bleeding
* History of difficult colonoscopy, strictures or extensive diverticulosis
* Antibiotics in the last month
* Probiotics in the last week
Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer \[SCLC\])
* Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria
* Eastern Cooperative Oncology Group performance status of ≤1 at study entry
* Accessible for treatment and follow-up

Exclusion Criteria:

* Brain metastases
* Malignant pleural effusion
* Autoimmune disease
* Motor neuropathy of autoimmune origin
* SCLC-related paraneoplastic syndromes
* Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)
* Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.

  * Grade 2 peripheral neuropathy (motor or sensory)
* Known HIV or hepatitis B or C infection
* Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
* Inadequate hematologic function defined by an absolute neutrophil count \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or hemoglobin level \<9 g/dL.
* Inadequate hepatic function defined by a total bilirubin level \>2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present.
* Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN
* Inadequate creatinine clearance defined as less than 50 mL/min.
Artificial Intelligence for Improved Echocardiography

The purpose of this study is to assess the effect of artificial intelligence algorithms on image quality in echocardiography.

The study population will be recruited from appointed patients at the Clinic of Cardiology, St. Olavs Hospital. After being informed about the study, all patients giving informed consent and meeting the eligibility requirements will undergo their standard clinical echocardiographic exam performed by a sonographer at the clinic. Two additional examinations will then be performed by a different sonographer and an expert cardiologist, respectively.

In one of the study arms the sonographer randomized to perform the second exam will use the AI algorithm (intervention).

Eligibility Criteria:
Inclusion Criteria:

* Capacity to consent

Exclusion Criteria:

* Indication for echocardiographic contrast agents
Why in PACU After Prostastectomy 2016

This study aims to describe the postoperative functions of patients after undergoing open or robotic prostastectomy. Primary endpoints will focus on complications in the post-anaesthesia care unit (PACU) which prevent dischard from PACU to the general ward. This include Aldrete scores and other complications that can be registrered descriptively. Furthermore, the study seeks to compare what influence open versus robotic prostastectomy have on peri- og postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Histology diagnosis of prostate cancer
* Surgery intended for removal or staging of prostate cancer: open prostatectomy, robotic prostastectomy, open staging surgery, laparoscopic staging surgery.

Exclusion Criteria:

* Patients with prostate cancer that do not have surgery.
* Surgery regarding only removal of distant mestatases origined from prostate cancer.
Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus

Based on the evidence summarized in the introduction, the clinician hypothesize that the detection of the presence and expression of HPV-DNA, certain miRNAs, and a certain mutational profile in the tissues and biological fluids of these patients, may have important prognostic and diagnostic value not only in HPV-related OPSCCs but also in HPV+ occult T. Accordingly, this study aims to aim to better characterize their potential as biomarkers and to detect the possibility of their their use to implement the sensitivity and specificity of radiological methodologies (PET-CT and MRI), already in use in clinical practice, for monitoring disease progression in this specific subgroup. Finally, by using the collected material to generate organoids and Patient Derived Xenograft (PDX), the study also aims to identify possible new molecular drugs, which could solve the problem of resistance to radiochemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node metastases laterocervical cytologically positive for squamous cell carcinoma treated with TORS or RT or RT/CT
* Age \> 18 years
* ECOG performance status \<_ 2
* Ability to follow study procedures and complete questionnaires
* Signature of informed consent

Exclusion Criteria:

* Presence of distant metastases at the time of diagnosis
* Previous cancer of the head and neck district
* Second tumor in therapy or follow-up for less than 5 years
Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced NSCLC Patients

Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.

This a multicenter prospective cohort study. This study will be proposed to newly diagnosed advanced NSCLC patients. For included patients, archived paraffin embedded tumor tissue will be used for sequencing ; and blood sample will be collected for research purpose (plasma DNA collection and sequencing).

Both tissue and liquid biopsy samples will follow usual processes and will be sent to the Molecular Pathology laboratory of the Investigation center.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged ≥ 18 years at time of proposal study,
2. Histologically confirmed non-small cell lung carcinoma,
3. No previous treatment for NSCLC,
4. Indication to EGFR status determination following HAS recommendation,
5. Voluntary signed and dated written informed consent prior to any study specific procedure
6. Patients with a social security in compliance with the French Law.

Exclusion Criteria:

1. Treatment for advanced NSCLC started before liquid biopsy sampling.
2. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study

The purpose of this pilot clinical trial is to evaluate the feasibility of the use of low-level laser for head and neck cancer survivors with lymphedema.

Primary aim:

To determine the feasibility of the use of LLLT for HNC survivors with lymphedema, specifically to 1) obtain recruitment estimates and determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety; and 4) evaluate patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Completion of either postoperative radiation or chemoradiation therapy
* No evidence of cancer
* Having head and neck external lymphedema
* Either completion of lymphedema therapy or not in active lymphedema therapy
* Ability to speak and read English
* Able to provide informed consent

Exclusion Criteria:

Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of LLLT: pregnancy; photosensitivity; chronic inflammatory diseases; venous thrombosis; history of severe trauma; medication that affects body fluid and electrolyte balance; use of high doses of non-steroidal anti-inflammatory drugs; or pre-existing skin rash, ulceration, open wound in the treatment area; and allergic and other systemic skin diseases.