cyrilzakka/clinical-trials huggingface dataset:
Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients

To report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (CXL) to assess preoperative factors that may influence ectasia progression

Purpose: To report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (CXL) to assess preoperative factors that may influence ectasia progression.

Methods: Thirthyfive eyes of 22 consecutive pediatric patients (mean age 14.3±2.5 years) with keratoconus are evaluated in this retrospective study. Subgroup A and B are made up in function of progression in maximum K (Kmax,) defined as steepening of 1.0 diopter or more recorded three year after CXL. Corrected distance visual acuity (CDVA), spherical equivalent, topographic cone location, Kmax, posterior elevation of the thinnest point and thinnest point are evaluated. A paired Student t test is used to compare preoperative and 12, 24, and 36 month postoperative da-ta. A P value \<0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

clinical diagnosis of Keratoconus age \< 18 years at the treatment iontophoretic corneal cross linking performed at least 3 years before

Exclusion Criteria:

age \> 18 years at the treatment

I
Ipilimumab Administered to Stage IIIC Stage IV Melanoma After Reg. T Cell Depletion With Denileukin Diftitox

This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.

This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥18 years of age;
2. Patients with histological confirmed melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2;
4. Life expectancy ≥3 months;
5. Treatment with Denileukin Diftitox within 42 days prior to first dose of Ipilimumab;
6. At least 1 site of radiographically measurable disease by immune-related response criteria (irRC);
7. Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:

   * Absolute neutrophil count (ANC) ≥1.0 x 109/L;
   * Platelet count ≥100 x 109/L;
   * Hemoglobin ≥8 g/dL;
   * Serum creatinine ≤3 x upper limit of normal (ULN)
   * Total serum bilirubin ≤2 x ULN;
   * Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤2x ULN, and ≤3 x ULN if liver metastases are present.
8. Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician;
9. Pre-menopausal females and females \<2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year;
10. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.

Exclusion Criteria:

1. Prior treatment with Ipilimumab;
2. Known hypersensitivity to Ipilimumab or any of its components;
3. Steroids within one week prior to initiation of Ipilimumab.
4. Pre-existing autoimmune colitis.
5. Patients with an allograft requiring immunosuppression;
6. Known positive human immunodeficiency virus (HIV)
7. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
8. Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study.
Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)

In this study the effect of the switch to rosuvastatin from another statin (fluvastatin, pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without evident CHD and LDL-C ≥ 3.2 mmol/l. This was done in a large observational study (TARGET) representing daily practice. Primary end points analysis was the percentage of patients reaching the target of LDL-C \< 3.2 mmol/l. Secondary outcomes were the changes of LDL-C, HDL-C, TC, Triglycerides (TG) and TC/HDL-C-ratio from baseline.


Eligibility Criteria:
Inclusion Criteria:

* High-risk patients with and without evident CHD who had LDL-C \> 3.2 mmol/l and were treated at that moment with HMG-CoA-reductase inhibitor apart from rosuvastatin.
* Patients were aged \>18 years and \<70 years (men) and \< 75 years (women).

Exclusion Criteria:

* Treatment with atorvastatin 40 or 80 mg or simvastatin 80 mg
* Patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases) and/or contra-indications for treatment with rosuvastatin
Surveillance of Regional Nodal Basins in Patients With Primary High Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck

In this prospective cohort study, investigators will conduct ultrasound surveillance of the nodal basins of patients with head and neck cutaneous squamous cell carcinoma (cSCC) whose tumors are considered high risk and staged by the Brigham and Women's Hospital (BWH) tumor staging system. The study will enroll patients with tumors staged T2a and who are also immunosuppressed (from solid organ transplant, hematologic malignancy or autoimmune disease), T2b (sentinel lymph node negative), and T3 (sentinel lymph node negative). After two years of surveillance, outcomes regarding local recurrence, nodal metastasis, disease specific death, and overall survival will be compared with historical controls with the overall hypothesis that ultrasound surveillance will detect subclinical disease earlier and help improve outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All cSCC must be on the head or neck
* All cSCC must be primary tumors.
* BWH stage T2a tumors in patients who are on chronic immunosuppression (organ transplant, hematologic malignancy, autoimmune disease)
* All BWH T2b or T3 tumors with a negative CT of the nodal basin AND a negative SLNB

Exclusion Criteria:

* Recurrent tumors
* Patients who are BWH T2b/T3 who have a positive CT of the nodal basin or positive lymph node biopsy
Evaluating the Impact of the McMaster Optimal Aging Portal on Physical Mobility Outcomes

The McMaster Optimal Aging Portal (the Portal) was launched in 2014 to increase public access to trustworthy health information. The Portal helps readers to access evidence-based resources; identify trustworthy messages; and understand scientific findings. Now the investigators want to know whether using the Portal changes what people know and do to stay healthy and mobile.

This project will help us to:

1. Understand how middle aged and older adults (age 40+) use the Portal to obtain information about maintaining and improving mobility
2. Evaluate whether use of the Portal results in a change in knowledge about maintaining and improving mobility, or change in lifestyle behaviours that may help maintain or improve mobility with age.

Physically active lifestyles are important for health aging, but most Canadians do not meet published physical activity guidelines. This may be in part due to lack of access to evidence-based information on mobility and aging, and knowledge of strategies to maintain or improve mobility with age. The McMaster Optimal Aging Portal (the Portal) was launched in 2014 to increase public access to trustworthy health information. Now the investigators want to know if easy-to-understand evidence-based messages change what people know and do to stay healthy and mobile.

Sequential, explanatory mixed-methods design consisting of a two-armed randomized controlled trial and a qualitative process study to explore quantitative findings in depth.

Consent forms and a baseline survey will be sent to all interested participants. Following baseline data collection, participants will be stratified by previous Portal use, and randomized to the Knowledge Translation (KT) intervention or control group. During the 12-week KT intervention, intervention group participants will have access to the Portal and will receive mobility- focused weekly email alerts including blog posts and evidence summaries relevant to mobility and be invited to follow a Twitter and Facebook feed; a unique hashtag will be created to identify and collate relevant mobility information. Control group participants will be able to access the Portal in a 'self-serve' fashion, but will not receive targeted KT strategies.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking

Exclusion Criteria:

* None
Effects of Exercise and Virtual Reality on Depression

This study is evaluating the effects of riding on a cycle ergometer while experiencing virtual reality to determine its effect on mood.

Adults (males and females) above the age of 18 yrs will be recruited to determine if they have symptoms of depression based on a questionnaire (Center for Epidemiologic Studies - Depression Scale (CES-D). They will then complete a Beck Inventory before and after the exercise. Participants will be divided into groups either having symptoms of depression or not. They will be randomized to ride on a cycle ergometer with or without using Virtual Reality (VR) that will allow them to view neighborhoods or parks during the exercise. The ergometer will be set at resistance raising the heart rate to 65% of their age-predicted heart rate maximum. They will ride for 20 min and then complete the Beck Inventory to determine any changes in their depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Males and females over the age of 18 years
* With or without symptoms of depression
* Physically inactive or sedentary (less than 30 minutes per day)
* Normal vision and no color blindness
* No physical disorders such as walking with assistance

Exclusion Criteria:

* Below the age of 18 years or over 65 years,
* Women who are pregnant
* Individuals who have been diagnosed with mental disorders
* Individuals with leg injuries
* Individuals with cardiac problems
* Individuals with a history of asthma
* Individuals with a body mass index over 30.
Genetic Diagnosis in Congenital Cataracts

The prediction of genetic risk in congenital cataract patients has great clinical significance. In this trial, the investigators aim to screen the causative variants from 115 unrelated bilateral congenital cataract patients enrolled consecutively, describe novel and recurrent variants, analyze the factors affecting genetic diagnostic yield, and explore potential phenotype-genotype correlation.

Determining whether the disease is hereditary and the precise genetic cause of congenital cataract has great clinical significance in guiding genetic counseling and improving clinical care pathway. Varying among studies, genetic causes account for 8.3-85% of congenital cataracts because of the difference in ethnic background, genetic screening techniques used, the percentage of patients with bilateral cataracts, with a family history, and with syndromic disease.

A phenotype-genotype correlation may be used to predict the causative genes, and the involvement of other tissues and organs based on the appearance of the lens. In addition, it can be used to improve our understanding of lens biology. A phenotype-genotype correlation is difficult to establish because of the genotypic and phenotypic heterogeneity of congenital cataracts.

In this trail, the investigators aim to screen the causative variants from 115 unrelated bilateral congenital cataract patients enrolled consecutively, describe novel and recurrent variants, analyze the factors affecting genetic diagnostic yield, and explore potential phenotype-genotype correlation. Facial and anterior eye segment photographs, pre- and post-operative ocular parameters, and medical and family histories were recorded. Bioinformatics analysis was performed using whole-exome sequencing data. Statistical and correlation analyses were performed using the basic characteristics, deep phenotype, and genotype data.

Eligibility Criteria:
Inclusion Criteria:

1. The participant with bilateral congenital cataract;
2. Have signed a consent form. .

Exclusion Criteria:

1. The participant not identified with congenital cataract; 2. The participant with unilateral congenital cataract.

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Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface

The purpose of this open, multicenter phase II trial is to confirm the tolerance and evaluate the efficacy of the SclerFIX product, an allograft of umbilical cord lining membrane, in reinforcement of scleral thinning in patients who underwent eye tumor exeresis.

As scleral graft is forbidden in France, it cannot be used to reinforce the sclera. This study investigational product, SclerFIX, was developed to substitute scleral grafts.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 80 years.
* Patients with risk of perforation or deep loss of substance during surgical removal of a tumor of the ocular surface.
* Patient with loss of substance \< 3cm2.
* Patient able to understand, sign and date the informed consent form.
* Patient who is a member or a beneficiary of a national health insurance plan.

Exclusion Criteria:

* Pregnant or breastfeeding woman or woman of childbearing age without effective contraception.
* Patients with uncontrolled infectious risk.
* Patient with an autoimmune disease.
* Person deprived of liberty by a judicial or administrative decision.
* Person under forced psychiatric care.
* Person admitted to a health or social institution for purposes other than the research.
* Adult subjected to a legal protection measure or unable to express his / her consent.
Optimizing Music-Based Interventions for Stroke

This study will enroll stroke patients and healthy participants. Participants will complete baseline measures followed by a music playing task during fMRI and simultaneous measurement of motor response using electromyography (EMG) and accelerometry and affective response using electrodermal activity (EDA) and self-reports. The music task consists of tapping an MRI-compatible MIDI drum with either: (1) improvisation or maintaining the beat and (2) live or recorded piano accompaniment. The primary objectives are to identify the motor, affective, and neural outcomes of improvisation and live accompaniment in music playing tasks.


Eligibility Criteria:
Inclusion Criteria:

For participants with stroke, to be eligible to participate in this study, an individual must meet all the following criteria:

* hemiparesis resulting from a stroke (ischemic or hemorrhagic) at least 6 months before the enrollment into the study
* age from 18 to 89 years
* ability to move the wrist flexor and extensor muscles without help from the healthy side, scoring above 3 on the Medical Research Council (MRC) Scale for Muscle Strength, reflecting active movement against gravity
* no more than mild resistance to passive movement in the wrist extensor muscle - as demonstrated by a score \<2 on the Ashworth Scale (Brashear et al.., 2002)
* a modified Rankin Scale (mRS) \< 3 indicating moderate to mild disability and the ability to ambulate independently (Bonita \& Beaglehole, 1988)
* ability to comprehend language and provide informed consent
* consenting to participate and willingness to complete MRI testing procedures

For neurologically normal control (NC) participants, to be eligible to participate in this study, an individual must meet all the following criteria:

* be matched for age, gender, and socioeconomic status (education level) to a previously enrolled participant with stroke
* age from 18 to 89 years
* no history of neurological injury
* ability to comprehend language and provide informed consent
* consenting to participate and willingness to complete MRI testing procedures

Exclusion Criteria:

* history of neurological injury other than stroke
* moderate to severe depression symptoms indicated by a score \>10 on the Patient Health Questionnaire - 9 (PHQ-9; Koenke et al., 2001; Williams et al., 2005)
* visual impairment unable to be corrected with glasses/contact lenses sufficient to allow reading comprehension
* actively performing or practicing a musical instrument more than 2 hours/week
* musical anhedonia indicated by a score \< 65 on the Barcelona Music Reward Questionnaire (BMRQ; Mas-Herrero et al., 2013)
* amusia as measured by the Montreal Battery of the Evaluation of Amusia (MBEA; Peretz et al., 2003)
* not being compatible with MRI testing, including having implanted devices, previous exposure to metallic fragments, large tattoos, claustrophobia, and pregnancy
Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis

For patients with unresectable colorectal cancer liver metastases, preclinical studies have shown that after the resistance of cetuximab, the treatment sensitivity can be restored by stopping cetuximab for a period of time. This is called the cetuximab re-challenge. And the circulating tumor DNA (ctDNA) test is reported a biomarker for the efficacy of cetuximab rechallenge. However, there is still no randomized controlled trial for verification. This study aims at patients after the first-line treatment of cetuximab has progressed. After the second-line non-cetuximab treatment has progressed, the effects of re-application of combined with cetuximab and chemotherapy alone are compared to verify the re-challenge effect.

Patients with colorectal cancer liver metastases were RAS wild type, received first-line cetuximab plus chemotherapy. After first-line progression, second-line non-cetuximab treatment were used. After second-line progression, ctDNA is test, and patients with RAS wild-type are enrolled in the study to compare cetuximab plus chemotherapy vs. chemotherapy alone as third-line treatment. Treatment will continue until disease progression or unacceptable toxic effects. The primary endpoint is the disease control rate，which will be assessed by local multidisciplinary team with the use of contrast-enhanced CT or MRI after 4 cycles and then every other 4 cycles up to 12 cycles.

Eligibility Criteria:
Inclusion Criteria:

1. Primary tumour was histologically confirmed colorectal adenocarcinoma;
2. Clinical or radiological evidence of non-resectable liver metastases;
3. With at least one measurable tumor;
4. Received first-line cetuximab (RAS gene wild type) treatment and progressed
5. Received second-line non-cetuximab treatment and progressed
6. Received circulating tumor DNA test and has RAS gene wild type status;
7. Performance status (ECOG) 0\~1
8. A life expectancy of ≥ 3 months
9. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
10. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (ALT)) ≤ 5 x ULN(within 1 week prior to randomization);
11. Written informed consent for participation in the trial.

Exclusion Criteria:

1. Patients with known hypersensitivity reactions to any of the components of the study treatments.
2. Acute or sub-acute intestinal occlusion
3. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
4. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix Known drug abuse/ alcohol abuse
5. Legal incapacity or limited legal capacity
6. Pre-existing peripheral neuropathy.
Assessment of Response to Neo-adjuvant Chemotherapy for Patients With a Locally Advanced Breast Cancer With 3D Elastography (Shear Wave),

Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy in patients with locally advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Infiltrating Breast Cancer untreated and/or locally advanced (stages I (T1c), IIa IIb, IIIa, IIIb, IIIc of UICC classification), whatever histological type.
* Neo-adjuvant chemotherapy decided.(Anthracyclines, taxanes and, for tumors overexpressing human epidermal growth factor receptor 2 (HER2) protein, targeted recombinant humanized monoclonal antibodies)
* Index tumor whose dimensions are between 10 to 50 mm. Multifocality, and/or multicentricity and/or bilaterality accepted (maximum 2 tumors by breast et tumors well differentiated from each other).
* Patients aged at least 18 years old at diagnosis
* Full results conventional breast exams available and no reason to achieve MRI breast exam
* Patient explanation given and consent information signed

Exclusion Criteria:

* Pregnant or during lactation
* Personal history of ipsilateral breast cancer (ipsilateral recurrence or second cancer in the same breast).
* Patient carrier of cosmetic breast implants
* Person deprived of liberty or under guardianship
* Contraindication for receiving neo-adjuvant chemotherapy for any medical reason
* Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.
Should Colon or Non-colon Originated Lesions be Distinguished?

This prospective study was designed to compare the difference of effects of conventional treatment, medicine intervention, endoscopic therapy, and surgery between colon originated and non-colon originated ALGID in critical patients, in order to alert doctors to differ the treatment of the two ALGID and provide basis for treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients in our ICU aged 18-75 years.
2. Patients with a confirmed diagnosis of ALGID.

Exclusion Criteria:

1. mechanical intestinal obstruction (including tumor, stercoral obstruction etc.)
2. gastrointestinal hemorrhage within 72 hours.
3. history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or radiation enteritis.
4. pregnancy.
5. contraindications of neostigmine administration.