cyrilzakka/clinical-trials huggingface dataset:
Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation

Extend evaluation of deferasirox film-coated tablet (FCT) formulation

Collection of additional safety and efficacy data with deferasirox film-coated tablet (FCT) in patients who had completed study CICL670F2201

* Provide patients who completed 24 weeks of treatment in the core study, CICL670F2201, the possibility to have additional treatment with the deferasirox FCT.
* Collect additional longer term data on the safety and the tolerability of the deferasirox FCT.
* Collect efficacy data on the deferasirox FCT in reduction or maintenance of iron burden as measured by serum ferritin level.

Eligibility Criteria:
Key Inclusion Criteria for subjects:

* Completed 24-weeks of study treatment as described in the core protocol (CICL670F2201).
* Were deemed to have tolerated deferasirox treatment by the investigator.
* Provided written informed consent/assent before any study-specific procedures were performed. For pediatric patients, consent was obtained from parent(s) or legal patient's representative. Investigators were to have also obtained assent of patients according to local, regional or national guidelines.

Key Exclusion for subjects:

The exclusion criteria followed those described for the core protocol CICl670F2201, which were as follows:

* Creatinine clearance below the contraindication limit in the locally approved prescribing information.
* Serum creatinine \> 1.5 × upper limit of normal range (ULN) at Screening
* Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) \> 5 × ULN,
* Significant proteinuria
* Patients with significant impaired gastrointestinal function or gastrointestinal disease
* Clinical or laboratory evidence of active Hepatitis B or Hepatitis C
* Patients with psychiatric or addictive disorders
* Patients with a known history of HIV seropositivity (Elisa or Western blot).
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was an evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
* Patients with a history of hypersensitivity to any of the study drug or excipients.
* Patients with significant medical condition that could interfere with the ability to participate in this study
* Patients who were participating in another clinical trial or receiving an investigational drug.
* Patients using prohibited medication,
* Patients with liver disease with severity of Child-Pugh Class B or C.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using effective methods of contraception during dosing of study treatment
A Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （CROWNS-2）

This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM310, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM310 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).

The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period and 28 weeks for open-label maintenance treatment) and Safety Follow-up Period (8 weeks).

180 patients who meet eligibility criteria will be randomized 1:1 to receive either CM310 300 mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 12 times at the double-blind treatment period and 14 times at the open-label treatment period. All patients will receive MFNS on a daily basis as a background treatment throughout the study.

Central reading will be implemented to nasal endoscopic nasal polyp score (NPS) , CT scans to Lund-Mackay score and volume of the involved area of nasosinusitis on 3D-construction images, and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.

Eligibility Criteria:
Inclusion Criteria:

* with chronic rhinosinusitis with nasal polyposis (CRSwNP).
* Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity.
* NCS score of 2 or 3 at screening period, and at least 2 at baseline.
* Contraception.

Exclusion Criteria:

* Not enough washingout period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for IL-4Rα antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).
* Participated and any studies of CM310.
* With malignant or benign tumor of nasal cavity.
* Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.
Cardiac Assessment in Obese and Overweight Children

Is to assess cardiac functions of overweight and obese children attending assiut University children hospital in one year duration .

The prevalence of overweight and obesity in children is increasing worldwide at an alarming rate in both developing and developed countries .the relation between obesity and cardiac structure and function in children is less well documented and conflicting results have been reported .In addition, obesity is associated with a heterogeneity of metabolic abnormalities , (e.g., dyslipidemia , insulin resistance hyperglycaemia and hypertension , that may provide a plausible biologic link between obesity and the increased risk of cardiovascular morbidity and mortality .The clustering of these risk factors for cardiovascular disease is referred to as the "metabolic syndrome." Although the concept and definition of the metabolic syndrome are controversial at the moment, there is no doubt that a cluster of cardiovascular risk factors is present in obese children and adolescents and that their presence increases with worsening obesity .children are likely to be the ideal candidates for providing insight into the myocardial changes related to obesity because they are suggested to be free of other cardiovascular risk factors indifferent echocardiographic studies .

Eligibility Criteria:
Inclusion Criteria:

1. - Age: children at 2-18 years .
2. - Overweight children whose body mass index at or above the 85th percentile and below the 95th percentile for the same age and sex
3. - Obese children whose body mass index at or above the 95th percentile for the same age and sex.

Exclusion Criteria:

1- Obese children below two years 2 - Cases with syndromic obesity, diabetes

* thyroid and parathyroid and those with congenital heart diseases
Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate

Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. In a prospective randomised study we wish to test the hypothesis that the TSP does not give any additional stability to the fracture treated with the DHS.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5)
* (can include; Patients with cognitive problems (ie. dementia etc)

Exclusion Criteria:

* Patients with pathological fractures
* Multitrauma patients
* Patients not able to walk before the fracture
* Under 19 years old.
* Patients with fractures needing other treatments than gliding hip screws
* Reverse oblique fractures.
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.

Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of acromegaly
* availability to carry out outpatient checks
* ability to provide informed consent

Exclusion Criteria:

* Pregnancy
* use of glucocorticoids (except those in use for replacement therapy)
* alcohol abuse
* exacerbation of chronic disease
* serious comorbidities (renal or hepatic failure, heart attack, stroke)
* terminally ill, prolonged immobilization (\>1 week)
* clinically evident fracture within the previous six months
* any other cause of secondary osteoporosis within the last five years
* any prolonged treatment with drugs with documented influence on bone metabolism during the previous 12 months, including treatment with antiresorptive or anabolic compounds for osteoporosis.
Simvastatin as a Treatment for Pulmonary Hypertension

The purpose of the study is to investigate the safety and efficacy of adding simvastatin to the current conventional treatment regimen for the management of pulmonary hypertension.

Pulmonary arterial hypertension (PAH) is a disease that is characterised by progressive narrowing of the blood vessels of the lungs. This results in a pressure load on the heart and heart failure.

The narrowing is in part due to constriction but mostly due to structural changes in affected vessels. The structural changes affect all cell components of the vessel wall (the endothelial lining, the muscle layer and fibrous tissue) and can lead to local clot formation. In addition there is evidence of inflammation of the vessels and what is known as oxidative stress. The disease may occur with no obvious cause, when it is known as idiopathic, but it can also be associated with a variety of other diseases, including congenital heart disease, collagen vascular disease and HIV infection.

Current approaches to the treatment of pulmonary hypertension are unsatisfactory as they do not prevent disease progression and do not directly or adequately address many of the processes detailed above. Alternative or additional treatments are therefore required and an attrative approach is to use a statin (a 3-hydroxy-3-methylglutaryl-coenzymeA, or HMG-CoA, reductase inhibitor). Statins are widely used for their ability to lower blood cholesterol but increasing evidence indicates that these drugs also have direct effects on cell components of the vessel wall - including inhibiting inflammation, clot formation and oxidative stress - that might be beneficial in pulmonary hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic PAH or PAH related to collagen vascular disease
* Age 18 years or over
* Receiving conventional therapy with diuretics, digoxin, warfarin, sildenafil and bosentan. Stable for 1 month
* 6 minute walk distance between 150m and 450m
* Modified NYHA functional class II or III

Exclusion Criteria:

* PAH from a cause other than permitted by entry criteria
* Change in PAH treatment in past 4 weeks
* Patients requiring prostanoid therapy
* Patients already taking a statin
* Clinically significant disturbance of liver function - AST or ALT \>3xULM; bilirubin \>1.5xULM
* Contraindication for a magnetic resonance scan
Binocular Visual Therapy and Video Games for Amblyopia Treatment.

Amblyopia, or lazy eye, is best defined by the American Academy of Ophthalmology as a unilateral or bilateral reduction of the best corrected visual acuity that occurs in the setting of an otherwise normal eye, or a structural abnormality involving the eye or visual pathway with reduction in visual acuity that cannot be attributed only to the effect of the structural abnormality. Which causes an abnormal visual experience early in life, with consequences such as deficiencies in the ability to perceive contrast and/or movement, visual acuity, accommodation and stereopsis. The treatment of choice consists in patching of the fellow eye 2 hours per day. The disadvantage of this treatment modality is that patients end up not complying and when treatment is interrupted, lazy eye reappears. Amblyopia was thought to be a monocular disease, now a days there are reports of cortical visual paths changes in both eyes (the fellow and amblyopia eye), believing that it might be a monocular consequence of a binocular disease. Following that statement new treatment studies have arisen, stimulating both eyes not only to improve visual acuity in the lazy eye, but to restore binocular function as well. These treatments use videogames in celular phones, computers, or tablets where the fellow eye is exposed to reduced contrast and the lazy eye is exposed to full-contrast. Although the evidence is promising, more studies are needed to establish effectivity and security of this treatment modality.

The objective of this study is to determine if the binocular visual therapy with red-green glasses and the use of electronic devices is effective for amblyopia treatment in children.

Participants will be randomly assigned to one of three treatment modalities: Group A: eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc) Group B: an eye patch on the fellow eye and a electronic tablet Group C: red/green glasses and a electronic tablet

Treatment will be done buy the three groups daily during 2 consecutive hours, and will be completed for four months. Children will then suspend the therapy for 2 months, and will be reevaluated to determine lazy eye relapses . All groups will be compared to see which patients achieved greater improvement on visual acuity and depth perception.

Eligibility Criteria:
Inclusion Criteria:

* Patients with anisometropic amblyopia, strabismic amblyopia or both
* Patients with out previous amblyopia treatment
* Patient with previous strabismus surgery or use of there best corrected visual acuity glasses for at least 1 month
* Birth at term gestational age
* Without any systemic or ophthalmic comorbidities
* Previous patients parent verbal and fiscal assessment.

Exclusion Criteria:

* Any other amblyopia diagnosis (deprivation)
* Any previous amblyopia treatment
* Any previous intraocular surgery
* Any ocular condition
* Any neurologic conditions or psychomotor development alterations
* Patients not able to cooperate for visual acuity or stereopsis evaluation
Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations

A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.


Eligibility Criteria:
Inclusion Criteria:

* healthy men or women, 12 years of age and older
* willing to participate and sign a copy of the informed consent form
* moderate to severe facial acne

Exclusion Criteria:

* history of allergy or hypersensitivity to clindamycin or benzoyl peroxide
* pregnant or lactating women
* evidence of a clinically significant disorder
* receipt of any drugs as part of a research study within 30 days prior to study dosing
* use of systemic, topical or facial products which may interfere with study
* significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn
Using Technology for Prediction and Prevention of Infant Torticollis and Plagiocephaly

The goal of this clinical trial is to test whether an app-based intervention can reduce the likelihood of a torticollis diagnosis in infants. The main question\[s\] it aims to answer are:

* whether an app can successfully deliver an intervention to parents of young infants
* whether parents who learn about torticollis will increase behaviors intended to prevent torticollis compared to parents who learn about general infant development

Participants will complete a monthly survey for 6 months asking about their parenting behaviors. Researchers will compare parents who receive notifications about torticollis with parents who receive notifications about general infant development to see if increased knowledge of torticollis leads to preventive behavior.


Eligibility Criteria:
Inclusion Criteria:

* any parent with an infant under a month old who can answer a survey in English

Exclusion Criteria:

* infant already has a diagnosis of torticollis or plagiocephaly
Efficacy and Safety of an Ectoine-containing Cream in the Treatment of Mild to Moderate Atopic Dermatitis

This study evaluates the efficacy of the topical used ectoine-formulation EHK02-01 compared to Atopiclair. Patients are examined at visit 2 (baseline visit). The patient topically applies EHK02-01 or Zarzenda® twice daily on two symmetric lesional areas over 28 days. Response to therapy is recorded at each visit.


Eligibility Criteria:
Inclusion Criteria:

* Female or male individuals between 18 and 65 years in good general health diagnosed atopic dermatitis for ≥ 6 months, in active stage (active stage means severity as measured by overall IGA-Score between 1 and 4)
* At least two comparable areas of stable atopic eczema on bilateral symmetric corresponding sides of the extremities or the body (except for head and genital area), each of at least 10 cm², with a modified, objective local SCORAD of the test areas \> 5
* Both lesional areas of interest must have a difference in the modified, objective local SCORAD of ≤ 3
* Willingness to adhere to the schedule of the investigation, concomitant therapy prohibitions, restrictions, treatment regimen and procedures described in the CIP
* Written informed consent to participate in the trial, prior to any investigation related procedures, indicating an understanding of the purpose of the clinical investigation
* A patient of childbearing potential agrees to use a contraceptive methods for the duration of the investigation according to CPMP/ICH 286/95 note 3

Exclusion Criteria:

* Patients who are self-reported to be pregnant, nursing or planning pregnancy during the clinical investigation
* Patients with any skin disease that in the investigator's opinion may interfere with the conduct of the study or the evaluation of the results (e.g. psoriasis)
* Patients with a known malignancy
* Presence of any disease and/or condition and/or history of diseases and/or conditions that according to the investigator may interfere with the conduct of the investigation or the evaluation of the results (such as abnormal laboratory values, chronic inflammatory dis-eases, immunosuppressive diseases, autoimmune diseases, liver or kidney diseases, severe infectious diseases)
* Patients who did not respect the wash-out periods prior to and during the clinical investigation
* Vaccination within 6 days prior to enrolment and during the study.
* Patients with a known allergy against any ingredient of the test products
* Patients who are known to have had a substance abuse (drug or alcohol) problem within the previous 12 months
* Patients who participate in another clinical trial or have participated in another clinical trial within the last 30 days prior to the first day of investigation
* Patients who are involved in the organization of the clinical investigation
* Patients that are in any way dependant on the investigator
Application of MACS and Time-lapse Technology in Good-prognosis Patients

The MACS technique (magnetic-activated cell sorting) is based on the usage of microbeads, magnetic particles with a diameter of 35 nanometers joined to the compound annexin V. Annexin V is a protein with a high affinity for the molecule phosphatidylserine. This system allow us to eliminate those spermatozoids which have begun the apoptosis and have phosphatidylserine residues on their membrane surface. Using this technique, the apoptotic spermatozoids will join the microbeads and consequently be retained in a column applying a magnetic field.

Recent studies show the benefits of spermatozoid selection using MACS and the improvement in mobility, viability, DNA fragmentation and fertilization potential. It has also been observed an improvement in the embryo cells division rate, clinical pregnancy rates and spermatozoid survival after thawing. However, it is necessary to perform new clinical studies in order to evaluate the real potential of this technology and its safety.

The purpose of this study is to evaluate the effect of the MACS technique on the clinical results of good-prognosis patients who are going through IVF/ICSI treatments in order to achieve a pregnancy.

The hypothesis of this study is that the application of the MACS technique in assisted reproduction treatments is associated with a better embryo quality and pregnancy rates.


Eligibility Criteria:
Inclusion Criteria:

* \<38 years
* \>10 follicles with a diameter of ≥10 mm the day before the follicular puncture

Exclusion Criteria:

* Patients subject to preimplantation genetic diagnosis treatments
Erlotinib in Treating Patients With Barrett Esophagus

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Erlotinib may keep esophageal cancer from forming in patients with Barrett esophagus by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with Barrett esophagus.

OBJECTIVES:

Primary

* To determine if erlotinib hydrochloride can be used as a chemopreventive agent that can cause histologic regression of Barrett esophagus in patients at high risk of developing esophageal cancer associated with high-grade dysplasia.

Secondary

* To assess whether erlotinib hydrochloride can cause molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy in Barrett esophagus with high-grade dysplasia.
* To establish surrogate markers of chemoprevention in Barrett esophagus with high-grade dysplasia.
* To validate the histologic scoring of Barrett dysplasia developed by our group.
* To evaluate toxicities associated with the use of erlotinib hydrochloride in patients with Barrett esophagus associated with high-grade dysplasia.

OUTLINE: Patients receive oral erlotinib hydrochloride once daily for 3 months. Patients showing no evidence of progression to cancer by esophagogastroduodenoscopy (EGD) with biopsy receive an additional 3 months of treatment. All patients then undergo repeat EGD, biopsy, and determination of molecular markers (i.e., EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy).

After completion of study treatment, patients are followed for 30 days.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of Barrett esophagus with high-grade dysplasia
* Refused surgery or other localized therapy for high-grade dysplasia
* No invasive esophageal carcinoma

PATIENT CHARACTERISTICS:

* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10 g/dL
* Bilirubin normal
* AST and ALT \< 3 times upper limit of normal (ULN)
* Alkaline phosphatase \< 3 times ULN
* No uncontrolled medical condition
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 1 week after completion of study treatment
* Able to swallow tablets or dissolved tablets
* No known hypersensitivity to erlotinib hydrochloride
* No symptoms suggestive of malignancy (e.g., weight loss or vomiting)
* No history of other malignancies
* No uncontrolled medical or psychiatric condition that would preclude treatment under this clinical trial

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior exposure to erlotinib hydrochloride
* No concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal therapy
* No concurrent investigational agents