cyrilzakka/clinical-trials huggingface dataset:
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye

Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.

Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor in male or female subjects 30 to 65 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age 30 through 65 years at the time of consent
* Binocular vision
* Subject desires refraction for correction of visual acuity and vision can be corrected in each eye to 20/20 (LogMAR 0.0)
* Willing and able to give informed consent and follow all study procedures and requirements
* Ability to speak and understand the English language

Exclusion Criteria:

* Spherical correction \> +8 or \< -10
* Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study
* Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study
* Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the device
* Eye disease, including but not limited to:

  * Glaucoma (≥ 22 mmHg intraocular pressure)
  * Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract \[any grade using the Lens Opacities Classification System III\])
  * Macular degeneration (retinal pigmented epithelium mottling and/or any drusen within 500 μm of macula)
  * Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis)
  * Keratoconus
  * Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy)
  * Cytomegalovirus retinitis
  * Color blindness (any color deficiency)
  * Diabetic macular edema (evidence of fluid)
  * Amblyopia
  * Chronic or acute uveitis (cells and/or flare in anterior chamber)
  * Strabismus (exotropia, esotropia, and hypertropia)
  * Abnormal astigmatism (mild to severe, \> 5 diopters)
  * Macular hole
* Eye surgery within the last 12 months (including Lasik or lens replacement)
* Subject does not have the physical dexterity to properly operate the device or the on the smartphone in the investigator's opinion.
Impact of Tixel Treatment on Symptoms and Signs in Patients with Dry Eye Disease

This study will examine how a standard Tixel treatment versus a sham treatment for eye wrinkles affects the symptoms and signs of Dry Eye Disease.


Eligibility Criteria:
Inclusion Criteria:

1. Mild to Moderate Periorbital wrinkles
2. OSDI score of at least 23
3. Noninvasive Tear film break up time (NIBUT) ≤ 10 seconds
4. No other eye or skin or immune problems
5. Willing and able to provide written informed consent.
6. Willing to participate in all study activities and instructions.

Exclusion Criteria:

1. Pregnancy and/or breastfeeding
2. Lesions in the periorbital area
3. Acute severe blepharitis
4. Acute conjunctivitis
5. Use of eye drops within 2 hours before examination
6. Other concomitant anterior eye disease
7. Has undergone outdoors/sunbed tanning during the last 4 weeks
8. Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
9. Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
10. Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
11. An impaired immune system condition or use of immunosuppressive medication.
12. Collagen disorders, keloid formation and/or abnormal wound healing.
13. Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course of the Tixel2 device treatment, or before complete healing of such treatments has occurred.
14. Any patient who takes or has taken any medications (including via topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin healing during the last 3 months.
15. Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less.
16. Any patient who has a history of bleeding coagulopathies or use of anticoagulants.
17. Any patient who has tattoos or permanent makeup in the treated area.
18. Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
19. Any patient who underwent thread lifting of the area to be treated in the last 3 months.
A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.

In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in this extension trial and receive chelation therapy with deferasirox for up to 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Completion of the planned 12-month core trial, (NCT00390858).
* Female patients who have reached menarche and who were sexually active were to use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
* Written informed consent obtained from the patient, and/or from the parent or legal guardian in accordance with the national legislation.

Exclusion Criteria:

* Pregnant or breast feeding patients
* Patients with a history of non-compliance to medical regimens and patients who are considered by the investigator as potentially unreliable.

Other protocol-defined exclusion criteria may apply.
Role of Echocardiography in Guiding Fluid Therapy in Shocked Patients With Impaired Cardiac Contractility in Emergency Department

fluid therapy is one of the cornerstones in the management of shock but may result in iatrogenic fluid overload .The aim of this study was to assess the role of echocardiography in guiding fluid therapy in shocked patients with impaired cardiac contractility using straight leg raising test ,Inferior vena-cava collapsability index and Doppler imaging in Emergency Department in Alexandria main university hospital.


Eligibility Criteria:
Inclusion Criteria:

* shocked patient with impaired cardiac contractility

Exclusion Criteria:

* Trauma patients.
* Patient with unstable arrhythmias.
* Patients with lower limb amputation.
* Mechanically ventilated patients.
* Patients with prosthetic aortic valve.
* Patients less than 18 years old
* Pregnant.
Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients

The aim of this study is to investigate the analgesic effects of thoracal paravertebral block in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to the study group. Conventional analgesia methods were applied to the control group.

Randomization was divided into two groups by using closed envelope method. Postoperative pain scores at rest at 1, 2, 4, 6, 8, 10, 12, and 24 hours with VAS (0 = no pain, very severe pain = 10) using Visual Analogue Scale was made. VAS at rest and movement (coughing and taking a deep Breath) were evaluated. Patients with VAS\> 4 received additional analgesics.

Eligibility Criteria:
ASA I, II, III patients aged 18-65 who consented to undergo unilateral percutaneous nephrolithotomy were eligible for the study. 53 patients were eligible and assesed.Informed consent was signed by all patients. Patients under 18 years of age, pregnant, with known hypersensitivity to local anesthetics, bleeding diathesis, depression and / or anxiety disorder, obesity (BMI\> 35kg / m2), history of pneumothorax, phrenic nerve paralysis, severe aortic stenosis were excluded. Also who did not want to participate the study.
The "Open Wound Bone Augmentation Concept" with Amnion-Chorion Membrane

The purpose of this study is to compare two bone graft wound healing techniques; an open wound healing approach versus the standard closed wound healing approach.

Open wound healing approach (experimental technique): the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta (the tissue sac that surrounds an embryo) and will be left partially open to heal.

Closed wound healing approach (standard technique): the wound where the graft was attached to the bone will be filled with collagen tissue (processed bone grafts from donors) and stitched closed while it heals.

20 patients needing more bone before placing a dental implant will be recruited for this trial. Patients will be randomized to either the test (open wound healing approach) or control (closed wound healing approach) group.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 21 years of age
* Be missing 1 to 2 back teeth in the lower jaw for at least three months
* Need horizontal bone ridge augmentation (gain width of the bone) prior to implant placement, determined clinically and radiographically
* Have enough bone height at the site

Exclusion Criteria:

* Currently smoke more than 10 cigarettes a day (self-reported)
* Have any medical conditions or jaw pathology that we decide might influence the outcome of the study
* Are pregnant or are lactating (self-reported)
* Have unstable periodontal disease or other dental infection
* Have poor oral hygiene
* Have any clinical conditions that make the subject unsuitable for bone graft surgery
Constitution of a Cohort for Monitoring Patients Candidating for Ovarian Tissue Autograft

Ovarian cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments. In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft. In France, the first live birth after orthotopic ovarian transplantation, was obtained by Roux et al. in 2009.

This clinical trial aims to build a cohort of patients likely to use their ovarian tissue cryopreserved by autograft.

Ovarian cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments. In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft. In France, the first live birth after orthotopic ovarian transplantation, was obtained by Roux et al. in 2009.

This clinical trial aims to build a cohort of patients likely to use their ovarian tissue cryopreserved by autograft. This cohort will be used to:

* Follow up of patients with their cryopreserved ovarian tissue;
* Evaluate requests for ovarian tissue grafting ;
* Propose a search of residual disease in case of neoplastic disease risk (if possible);
* Allowing patients to benefit from an ovarian tissue autograft;
* Assess the effectiveness of autograft technique after the restoration of ovarian function.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have cryopreserved their ovarian tissue;
* Patients with premature ovarian insufficiency;
* Patients older than 11 years (bone age) for induction of puberty;
* Patients aged from 18 to 43 years for the restoration of ovarian function;
* No objection from the patient
* Patients who have already received ovarian tissue autograft.

Exclusion Criteria:

* Patients aged under 11 years (bone age);
* Patients older than 43 years;
* Patients refusing to be included;
* Patients (adults) under guardianship, curators and safeguard justice
Phase II/III Study of WST09 in Prostate Cancer After Radiation Therapy

The aim of this clinical trial is to evaluate the efficacy and safety of the WST09-mediated vascular-targeted photodynamic therapy (VTP) in patients with localized prostate cancer recurrent after external radiation therapy or temporary (High Dose Rate, or HDR) brachytherapy.

This is a multicentre, open labelled, phase II/III, 6-month clinical trial with an additional follow-up at Month 12, aiming to determine the efficacy and tolerability of the WST09-mediated VTP treatment. This treatment consists of an I.V. infusion of WST09 (2 mg/kg), in combination with per-cutaneous interstitial illumination using laser light (wavelength at 763nm) delivered through optical fibres positioned through the perineum in the prostatic lobes.

Patients who are eligible to participate in the study must have a clinically diagnosed positive biopsy of the prostate (up to stage T2b-N0-M0) diagnosed after external radiotherapy or temporary brachytherapy (no seeds), and present with increasing PSA levels on three consecutive occasions (at least 3 months apart) post-radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

Histologically proven localized prostate cancer after receiving external radiation therapy;

Exclusion Criteria:

Patients unwilling or unable to give informed consent; Patients who received or are receiving chemotherapy; Patients previously treated with HIFU, cryotherapy, other salvage treatments, or with a trans-urethral resection of the prostate (TURP); Patients whose previous radiation therapy caused extensive cystitis and/or proctitis.

Patients suspected of Disseminated Intravascular Coagulation (DIC). Patients with prior history of coronary artery disease, angina pectoris, myocardial infarction, coronary angioplasty or coronary artery bypass graft, severe valvulopathy, cardiac failure, artrial fibrillation and / or sustained arrhythmia.

Patients whose cardiac status does not allow general anesthesia. Patients with history of thromboses or thrombo-embolisms. Patients with history of stroke or transient ischemic attack.
Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis

This study evaluates vitamin D as an adjunctive treatment in patients with non-Cystic Fibrosis bronchiectasis, which are combined with vitamin D deficiency. Half of participants will receive vitamin D supplementation, while the other half will receive placebo.

To define the therapeutic effect of Vitamin D in the treatment of non-Cystic Fibrosis bronchiectasis by means of a prospective randomized placebo-controlled double blind study with a follow-up of at least one year. To explore whether correction of Vitamin D deficiency by the oral supplementation of Vitamin D triggers the vitamin D receptors-mediated cathelicidin pathway and increases local or systemic concentrations of the natural antimicrobial polypeptide cathelicidin with enhanced eradication of bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-Cystic fibrosis bronchiectasis by High Resolution CT
* Age 18 years or older
* Vitamin D deficiency \[25(OH)D\<20 ng/mL\]
* Informed consent

Exclusion Criteria:

* Current active allergic bronchopulmonary or tuberculosis
* Diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, Human Immunodeficiency Virus infection, liver failure, renal failure or malignancy
* Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
* Taking dietary supplement or topical preparation containing vitamin D up to 2 months before first dose
* Treatment with any investigational medical product or device up to 4 months before first dose
* Breastfeeding, pregnant or planning a pregnancy
* Baseline corrected serum calcium \> 2.65 mmol/L
* Baseline serum creatinine \> 125 micromol/L
Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis

The primary objective of the study is to evaluate the efficacy of REGN2477+REGN1033 in combination on total lean mass, as measured by Dual-energy X-ray absorptiometry (DXA) in patients with sporadic inclusion body myositis (sIBM).

The secondary objectives of the study are:

* To evaluate the efficacy of REGN2477+REGN1033 on the IBM-Functional Rating Scale (IBM-FRS)
* To evaluate the efficacy of REGN2477+REGN1033 on the sIBM Physical Functioning Assessment (sIFA)
* To evaluate the safety and tolerability of REGN2477+REGN1033
* To evaluate the effects of REGN2477+REGN1033 on body composition by DXA, including appendicular lean mass and total fat mass
* To evaluate the efficacy of REGN2477+REGN1033 on measures of muscle performance and physical function
* To evaluate the efficacy of REGN2477+REGN1033 on patient reported outcome measures including the fear of falling, falls and near falls, and health-related quality of life
* To evaluate the pharmacokinetic(s) (PK) profile of REGN2477+REGN1033, including functional REGN2477 and functional REGN1033 concentrations in serum over time
* To evaluate the immunogenicity of REGN2477+REGN1033


Eligibility Criteria:
Key Inclusion Criteria:

* Men and postmenopausal\* women
* Diagnosed with sIBM based on the European Neuromuscular Centre (ENMC) IBM Research Diagnostic Criteria
* Ability to walk ≥150 meters, with or without a walking aid such as cane or walker, in 6 minutes.
* Ability to climb 4 steps of stairs unassisted (may use handrails)
* Willing and able to comply with clinic visits and study-related procedures

Key Exclusion Criteria:

* Other neurological conditions (eg, hemiplegia post stroke, Parkinson's) or musculo-skeletal conditions (eg, severe osteoarthritis) causing mobility impairment
* Mini-Mental State Examination (MMSE) score \<24
* Ongoing, chronic, high-dose (\>20 mg prednisone equivalent per day), systemic corticosteroid therapy within 6 weeks prior to screening.
* Any condition that precludes adequate intake of energy and protein; malnutrition; presence of an eating disorder.
* Unintentional weight loss of ≥10% in the past 6 months (patient-reported)
* Hospitalization for heart failure in last year or New York Heart Association Class 4
* History of hypertrophic cardiomyopathy
* Any drugs known to influence muscle mass and performance such as anabolic steroids or growth hormone within 6 weeks prior to screening
* Unable to fit on the site's DXA scanner table, within borders for scanning of total lean mass

Note: Other protocol Inclusion/Exclusion criteria apply
Standard Disease Activity Parameters and Step Activity in Patients With Rheumatoid Arthritis Receiving Etanercept

Data on activities of daily living in patients with rheumatoid arthritis are assessed mainly be the health assessment questionnaire (HAQ). The HAQ generates data by subjective variables. It would be desirable and advantageous to add objective tools reflecting patients' activities to the outcome parameters in rheumatoid arthritis. The StepWatch™ activity monitor (SAM) in an ankle worn step counter and an accurate instrument to measure real world ambulatory activity. The investigators purpose was to investigate whether activities of daily living measured by SAM increase during a therapy with the TNF-alpha inhibitor etanercept in patients with active rheumatoid arthritis (RA).

In the past decade treatment strategies for rheumatoid arthritis (RA) have changed dramatically. Today far more therapeutic options are available. Patients are being treated earlier and more aggressive than in the past.

These processes have had an influence on the outcome of patients with RA and on the way they are being evaluated.

Outcome variables are disease aspects or consequences that develop over the course of RA. The HAQ score has been shown to be a good predictor of patients outcome in RA. However, the HAQ ist a questionnaire and the score is influenced by subjective factors.

The Step Watch Activity monitor (SAM)is a highly accurate accelerometer-based step monitor. The SAM provides a detailed profile of the number of steps taken by a subject. It is a small unobtrusive device which is worn laterally at the right ankle. It weights only 65 grams and uses 2D accelerometry.

The SAM can provide objective information about activities of daily living.

Etanercept is a recombinant fully human TNF-receptor p75-Fc fusion protein. Numerous studies with etanercept have shown the clinical efficacy. This can be demonstrated by various disease activity scores (e.g the DAS28). In addition there is strong evidence that etanercept improves disability measured by the HAQ.

There are only few publications reporting about measuring physical activity in patients with joint diseases; all of these include patients with osteoarthritis.

Our aim is to include patients with active RA who receive etanercept. These patients are asked to wear the SAM for 7 days before treatment and 4 weeks and 12 weeks after initiation of therapy with etanercept. The step activity measured by the SAM will be correlated with the the clinical sore DAS28 and the HAQ.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active rheumatoid arthritis (Disease activity score -DAS28 \> 3.2) who are eligible to a treatment with etanercept.
* Age 18 and older
* Male or female

Exclusion Criteria:

* Contraindications against a therapy with etanercept
* Patients not able to comply with the requirements of the protocol