cyrilzakka/clinical-trials huggingface dataset:
Study of Fruquintinib in Patients With Metastatic Colorectal Cancer

Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced Colorectal Cancer (CRC) in Phase Ib study.

This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after metastatic CRC second line or above standard chemotherapy.

This is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial to compare the efficacy and safety of Fruquintinib plus Best Supportive Care (BSC) versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy.

After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1.

Primary Efficacy Endpoint:

Progression free survival (PFS) (According to RECIST Version 1.1).

Secondary Efficacy Endpoints:

Objective Response Rate (ORR), Disease Control Rate (DCR), Overall Survival (OS).

Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI common terminology criteria for adverse events (CTC AE) Version 4.0.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 and ≤ 75 years of age , with ≥ 40 Kg
* Histological or cytological confirmed metastatic colorectal cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Failed 2 or more lines of chemotherapy
* Adequate hepatic, renal, heart, and hematologic functions
* At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
* Signed and dated informed consent.
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure

Exclusion Criteria:

* Pregnant or lactating women
* Any factors that influence the usage of oral administration
* Central nervous system (CNS) metastasis
* One of the following conditions: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
* Abuse of alcohol or drugs
* Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR inhibition
* Disability of serious uncontrolled intercurrence infection
* Proteinuria ≥ 2+ (1.0g/24hr)
* Evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
* History of artery/venous thromboembolic events in 12 months, such as cerebral vascular accident (including transient ischemic attack) etc.
* History of acute myocardial infarction, acute coronary syndrome or coronary artery bypass graft (CABG) in 6 months
* Bone fracture or wounds that was not cured for a long time
* Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy
Early Effects of Intensive Lipid Lowering Treatment With Ezetimibe/ Simvastatin (Vytorin®) Assessed by Virtual Histology-Intravascular Ultrasound (VH-IVUS) and Optical Coherence Tomography (OCT) on Plaque Characteristics in Patients With Acute Coronary Syndrome

Objective: To evaluate the early effects of intensive lipid lowering treatments with ezetimibe/simvastatin (Vytorin®) for each component of coronary plaques.

Study Design

* Prospective, randomized, single-center study of each 80 subjects enrolled
* Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled.
* Eligible subjects will be randomized 1:1 to A) Ezetimibe/Simvastatin (n=80) vs. B) Pravastatin (n=80), and each group of patients will be randomized further in a ratio of 1:1 to a) ZES (n=40) vs. b) EES (n=40), according to the type of stent used.
* All subjects will undergo VH-IVUS at initial procedure.
* Follow-up VH-IVUS will be performed at 3 months after index procedure. OCT at initial procedure and 3-months will be performed in available cases.


Eligibility Criteria:
Inclusion Criteria:

General inclusion criteria

1. Acute coronary syndrome including unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction
2. Age of 20 years or older
3. Patients with signed informed consent

Angiographic inclusion criteria

1. De novo lesion without significant plaque (angiographic lumen diameter stenosis \< 50%)
2. Reference vessel diameter ?\> 3.0 mm by operator assessment
3. Segment length of 10-20 mm
4. Distance from the PCI site \> 5.0mm (either proximal or distal)
5. Available for serial high quality IVUS studies of the entire segment.

Exclusion Criteria:

1. Failed PCI
2. Recommended coronary artery bypass grafting (CABG)
3. Cardiogenic Shock
4. Administration of lipid lowering agents before enrollment
5. Significant hepatic dysfunction (3 times normal reference values)
6. Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl)
7. Significant leukopenia, thrombocytopenia, anemia, or known bleeding diathesis
8. Pregnant women or women with potential childbearing
9. Saphenous vein graft
Combination of Chemoradiation Therapy and Epitope Peptide Vaccine Therapy in Treating Patients With Esophageal Cancer

The purpose of this study is to evaluate the safety and immune response of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

Up-regulated ling cancer 10 (URLC10), TTK protein kinase (TTK) and K homology domain containing protein over expressed in cancer (KOC1) were identified as new targets of tumor associated antigens using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. Furthermore, anti-angiogenic therapy is now considered to be one of promising approaches for treating cancer. Vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) are essential targets for tumor angiogenesis. Epitope peptides for these targets are able to induce cytotoxic T lymphocytes (CTL) restricted to HLA-A \*2402 in vivo. On the other hand, chemotherapy (CDDP, 5-FU) plus radiation therapy has been to be a standard treatment for unresectable advanced esophageal cancer. In this clinical trial, we evaluate the safety and immune responses of different doses of multiple peptides (URLC10, TTK, KOC1, VEGFR1, and VEGFR 2) emulsified with Montanide ISA 51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have unresectable, locally advanced, recurrent or metastatic disease of esophageal cancer.
2. measurable disease by CT scan
3. ECOG performance status of 0 to 2
4. Expected survival of at lease 3months
5. Patients must be HLA-A2402
6. Laboratory values as follow:

   * WBC \> 2000/mm3,
   * Platelet count \> 75000/mm3,
   * Total bilirubin \< 1.5 x the institutional normal upper limits,
   * Creatinine \< 1.5 x the institutional normal upper limits,
   * AST. ALT. ALP \< 2.5 x the institutional normal upper limits
7. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Active or uncontrolled infection
4. Prior chemotherapy,radiation therapy or immunotherapy within 4 weeks
5. Concurrent treatment with steroid or immunosuppressing agent
6. Patient with peptic ulcer disease
7. Active or uncontrolled other malignancy
8. Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ
9. Disease to the central nervous system
10. Decision of unsuitableness by principal investigator or physician-in-charge
iCOMtrain, Development and Evaluation of a Combined Training of Technical and Non-Technical Skills During the Management of Simulated Incidents in Intensive Care

The normal, the anticipated difficult and the unanticipated difficult airway are trained in the patient safety simulation center (University Hospital Zürich) and the training is being observed by video installation.

Step 1: normal airway (Phantom), technical training

Step 2: difficult airway (SimMan 3G), technical training

Step 3: Simulation of normal and difficult airway management on ICU (SimMan 3G), technical and non-technical (CRM - crew resource management) training.


Eligibility Criteria:
Inclusion criteria:

* doctors and nurses with a minimum of 12 moths of work experience.

Exclusion criteria:

* staff members that deny participation or don't meet the inclusion criteria
Botox for Gummy Smile

This is a two part study to measure and observe the efficacy of botulinum toxin A for the treatment of gummy smiles.

Part A will randomly compare three different doses of botulinum toxin type A (abobotulinumtoxin A) for the treatment of upper anterior gummy smile with larger gingival exposure (\> 4 mm).

Part B will assign one of two doses of botulinum toxin type A for participants with smaller gingival exposure (\< 4 mm).

Follow-up visits with photography will occur 4 and 12 weeks after their treatment. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

This study is a pilot study designed to determine feasibility of this procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Males or females ≥ 18 years old
3. Anterior gingival exposure during smiling larger than 4 mm measured from the central incisor tooth (part A), or 2-4 mm (part B).
4. Subjects of childbearing potential who present a negative urine pregnancy test at baseline and use an effective contraceptive method.
5. Subjects are in good health as judged by the investigator.
6. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

1. Pregnant women or women intending to become pregnant in the next 8 months after the screening for eligibility
2. Subjects participating in other clinical trials
3. Any prior surgery affecting the area of study
4. Subjects with neoplastic, muscular or neurological disease
5. Subjects who have received botulinum toxin treatment for gummy smile in the previous 12 months before the inclusion date
6. Subjects who have received Botulinum toxin treatment for any other cosmetic indication in the previous 6 months before the inclusion date
7. Subjects using aminoglycosides and penicillamine antibiotics, quinine or calcium channel blockers
8. Subjects with inflammation or active infection in the area to be injected
9. Subjects with history of sensitivity to the components of the formulation.
10. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
11. Subjects who are unable to understand the protocol or give informed consent.
Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.

To compare 3 year iontophoretic transepithelial corneal cross-linking (I-ON CXL) outcomes with epithelium-off collagen cross-linking (epi-off CXL)in pediatric patients.

Forty eyes of 28 consecutive pediatric patients (mean age 14.3±2.5 \[SD\] years; range, 9 to 18 years) with keratoconus were enrolled in the study. Twenty eyes of 15 patients underwent I-ON CXL, while 20 eyes of 13 patients underwent epi-off CXL. Corrected distance visual acuity (CDVA), spherical equivalent, maximum keratometry (Kmax), posterior elevation of the thinnest point and thickness of the thinnest point mean values were evaluated. A Student t test was used to compare baseline and 12, 24, and 36 month postoperative data. Keratoconus progression in function of preoperative Kmax value and cone location was evaluated at 36 months.

Eligibility Criteria:
Inclusion Criteria:

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

Exclusion Criteria:

* age \> 18 years at the treatment
Study of the Intra-patient Variability of the Quantitative Parameters of Tumor Perfusion Evaluated With Ultrasound Contrast

RECIST criteria for evaluating tumor response are often inadequate for the evaluation of anti-angiogenic drugs. An evaluation model of tumor perfusion with contrast-enhanced ultrasonography was developed at Gustave Roussy. It assesses the tumor vascular response through the analysis of 7 different parameters. Several studies (four at IGR, involving 117 patients, and a multicenter study involving 400 patients) showed that CEUS allows early evaluation of the effect of anti-angiogenic drugs. Two of these parameters are particularly interesting for the early identification of patients responding (or not) to treatment. Those are area under curve , and area under the wash-out. To further validate the use of these parameters, it is essential to measure and describe the level of their intra-patient variability.


Eligibility Criteria:
Inclusion Criteria:

1. Patient being treated at IGR for metastatic cancer by anti-angiogenic (s) drug (s) in the following indications:

   * Gastrointestinal sarcoma (GIST)
   * Breast Cancers
   * Kidney Cancers
   * Colorectal Cancers
   * Melanoma

   These anti-angiogenic drugs are used alone or in combination: Bevacizumab (Avastin), imatinib (Gleevec), Sorafenib (Nexavar), sunitinib (Sutent), Everolimus (Afinitor) Temsirolimus (Torisel), ... (non exhaustive list).
2. With at least one clearly identified metastatic tumor lesion (and accessible to ultrasound for acquisition 3 minutes without losing the target), measuring more than 2 cm, less than 50% of the volume is necrotic.

   Metastatic lesions are:
   * Liver (30 patients)
   * Or outside the liver (30 patients)
3. Physiological Age: 18-80 years
4. performance status \<2
5. Patient information and signature of informed consent

Exclusion Criteria:

1. Background known hypersensitivity to sulfur hexafluoride or one of the components,
2. recent history of acute coronary syndrome or unstable ischemic heart disease,
3. Acute heart failure, heart failure stage III or IV, or severe rhythm disorders,
4. uncontrolled hypertension or severe pulmonary hypertension,
5. Right-Left Shunt,
6. Respiratory Distress Syndrome,
7. Patient without vascularized tumor (without contrast enhancement)
8. patient whose antiangiogenic has already started,
9. Pregnant woman likely to be or breastfeeding,
10. Persons deprived of liberty or under guardianship,
11. Unable to submit to medical monitoring of the trial for geographical, social or psychological reasons
The Association Between MIH and HSPM

Aim of the Study Evaluate association between HSPM and MIH in Egyptian children. Record the prevalence of HSPM and MIH in Egyptian children

Statement of the Problem:

Molar Incisor Hypomineralization (MIH) is defined as developmental qualitative defect of systemic origin, which affects one to four of first permanent molars and frequently associated with permanent incisors . The prevalence of MIH worldwide was reported from 2.4% to40.2% and clinical measures of MIH based on scientific criteria was established based on the European Academy of Pediatric Dentistry criteria to allow comparison between the findings of different studies .

The most commonly reported clinical problems for patients with MIH are hypersensitivity of teeth to various thermal and mechanical stimuli result in improper tooth brushing, plaque accumulation and rapid caries progression. Severely affected enamel shows post eruptive breakdown and such teeth require extensive treatment, ranging from prevention to restorations and extractions. MIH patients also have increased risk of developing dental fear and anxiety as well as behavior management problems added to the difficulty to achieve effective local anaesthesia which are related to chronic pulp inflammation from dentin exposure due to excessive enamel breakdown.

Rational As developmental of Second Primary Molar start at the same time as the development of the first permanent molars and incisor but the maturation of permanent teeth occur more slow. So when a systemic disturbance occur it affect second primary molar as well as first permanent molar and incisors.

Few studies test the association between hypomineralized second primary molar (HSPM) and MIH. While no study available on Egyptian children.

Eligibility Criteria:
Inclusion Criteria:

* Children aged from 8 to 9 years.
* Both genders.
* No systemic health problems

Exclusion Criteria:

* Children with extracted primary second molars and permanent incisors and molars.
* Children with history of dental trauma.
* Children with orthodontic bands or dental appliances
Mixed Reality in MitraClip Implantation: Preliminary Case Series

The study aims to evaluate the impact of mixed reality (MR) technology, particularly using Hololens 2.0 and specialized software for three-dimensional DICOM image visualization, on MitraClip implantation procedures. This preliminary case series includes a comparative analysis of four MitraClip implantations, assessing procedural efficiency, radiation exposure, and operator stress through both physiological and subjective measures.

The advent of mixed reality (MR) technology, especially when integrated with Hololens 2.0 and specialized software for three-dimensional DICOM image visualization, offers promising avenues for enhancing precision and spatial awareness in interventional cardiology procedures. This case series aims to preliminarily evaluate the impact of MR on MitraClip implantation processes, setting the foundation for a comprehensive pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged over 18 years
* Patients diagnosed with mitral valve regurgitation requiring MitraClip implantation
* Ability to provide informed consent and comply with study procedures

Exclusion Criteria:

* Patients with contraindications for MR technology (e.g., MRI incompatibility)
* Individuals unable to comply with study procedures due to physical or cognitive impairments
* Pregnant or breastfeeding women
Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load

Certain percentage of MDS patients develop iron overload. Iron is known to participate in intracellular reactions that generate free radicals, inducing oxidative stress and apoptosis, which was found to be increased in MDS patients and consequently resulted in ineffective hematopoiesis. The aim of this study is to evaluate the antioxidant effect of the oral iron chelator Deferasirox -Exjade in low risk MDS patients with iron over load by evaluating changes in several oxidative stress parameters Certain percentage of MDS patients develop iron overload.


Eligibility Criteria:
Inclusion Criteria:

* Patients with myelodysplastic syndrome with an IPSS score being Intermediate-1 or low.
* Patients who already received ≥20 unit (100 mL/kg) of packed red blood cells and showing evidence of iron overload (serum ferritin \>1000 µg/L).
* Patients post stem cells transplantation with disease recurrence with MDS IPSS score low or intermediate 1.
* Patients who have given consent personally in writing

Exclusion Criteria:

* Patients with myelodysplastic syndrome with an IPSS score being Intermediate-2 or High.
* Patients with serum creatinine \>2.0 x ULN
* Patients with ALT(SGPT) levels \> 5 x ULN
* Significant proteinuria as indicated by a urinary protein/creatinine ratio \>0.5 mg/mg in a non-first void urine sample on two assessments during the screening period.
* History of HIV positive test result. When there are any signs or symptoms indicative of the disease even if the diagnosis is not made, additional test should be conducted.
* History of clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above the normal range)
* Patients with systemic uncontrolled hypertension
* Patients with unstable cardiac disease not controlled by standard medical therapy
* Systemic disease (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
* Pregnancy or breast feeding. Female of child-bearing potential should conduct contraception during the clinical trial.
* Patients treated with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
* Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
* Patients being considered by the investigator potentially unreliable and/or not cooperative with regard to the study protocol
* History of hypersensitivity to any of the study drug or excipients
Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia

Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia for procedural pain on infant pain responses during a subsequent care giving procedure.

Pain in the newborn and young infant is a source of stress for the infant, family and care providers.

During hospitalization, a neonate undergoes a number of necessary procedures that may be either painful or cause discomfort to the baby.

Pain experienced during the neonatal period is known to have long term effects on the baby.

The red-reflex test is a routine examination performed on a neonate after birth and once again before discharge from the hospital. The examination causes discomfort to the infant.

Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. Our objective is to determine the effect of glucose 25% analgesia for procedural pain on infant pain responses during a subsequent care giving procedure.

Eligibility Criteria:
Inclusion Criteria:

* Full term above 37 weeks gestation.
* Normal birth-weight, healthy infants
* Males and Females
* Whose parents have signed the informed consent form

Exclusion Criteria:

* Premature born below 37 weeks
* Chromosomal abnormalities or congenital malformation.
* Suffering neurological imbalance
* Inability of oral feeding