cyrilzakka/clinical-trials huggingface dataset:
French Validation of Axial Spondyloarthritis Questionnaires (Val-SpA)

The aim is to do a French linguistic validation of three questionnaires used in axial Spondyloarthritis (BASFI, BAS-G, Dougados Functional Index).

In order to validate the questionnaires, a prospective, qualitative, observational and monocentric study will be conducted.

Axial spondyloarthritis (SpA) is a chronic rheumatic diseases affecting axial skeleton and sacro-iliac joints. SpA can have functional consequences, often assessed with the Bath Ankylosing Spondylitis Functional Index (BASFI), the Dougados functional index, or more globally with the Bath Ankylosing Spondylitis Global (BAS-G). If these questionnaires are validated in English, there are not validated in French. The aim is to do a french linguistic validation of these questionnaires.

A translation, reconciliation and retro-translation will be conducted for each of the questionnaires by two bilingual translators. The last version of each questionnaire will be then validated by clinicians experts in SpA. The version will be further validated by 5 patients. If necessary and if changes occured on the version of the questionnaire, another version will be validated by 5 other patients until full understanding is obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with axial spondyloarthritis or ankylosing spondylitis

Exclusion Criteria:

* Patients who do not understand French
* Patients with cognitive impairments
* People protected by law
* People who do not want to participate
Morphometric Examination of the Larynx

Objective: To measure laryngeal dimensions in a sample of Turkish cadavers including males and females of various ages and heights.

Patients and Methods: Morphological measurement was performed on 102 laryngeal specimens. Laryngeal cartilages were collected from human cadavers. All dimensions of the cartilages were measured using a thread and vernier calipers. Age, sex, and height were recorded. Results for men and women were compared.


Eligibility Criteria:
Inclusion Criteria:human cadavers -

Exclusion Criteria:

-
Scandinavian Urethroplasty Study

A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision and primary anastomosis or with an onlay grafting procedure using buccal mucosa.

The study is a prospective, randomized study to compare two common techniques of urethroplasty used to treat bulbar urethral strictures. One technique is excision of the stricture and end-to-end anastomosis of the urethra. The other technique is an onlay grafting procedure with buccal mucosa where the corpus spongiosum is not divided. The study is designed to compare complications of sexual and penile function, and is not powered to compare the success rates of the two techniques. The primary endpoint will be degree of erectile dysfunction and penile complications. The secondary endpoint will be restricturing leading to reoperation, and other complications.

Eligibility Criteria:
Inclusion Criteria:

Patient with bulbar urethral stricture, length estimated by urethrography or endoscopy ≤ 2 cm

Patient is able and willing to sign informed consent

Patient is able and willing to complete all study requirements

Exclusion Criteria:

Previous open urethroplasty

Previous hypospadia surgery

Previous surgery for congenital curvature or Mb Peyronie

Previous pelvic irradiation therapy

Known grave psychiatric disorder

Haemophilia or other clotting disorders that cause bleeding diathesis

Use of medication to increase erectile function, such as PDE5-inhibitors and intracavernous injections, during the study

Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease

The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease
2. Relatively stable airway obstruction with a post-bronchodilator FEV1\< 80% of predicted normal and a post-bronchodilator FEV1/FVC \<70%
3. Male or female patients, 40 years of age or older
4. Smoking history of more than 10 pack years
5. Ability to perform technically acceptable pulmonary function tests and maintain records
6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler (MDI)

Exclusion criteria:

1. significant disease other than COPD
2. clinically relevant abnormal lab values
3. history of asthma
4. diagnosis of thyrotoxicosis
5. diagnosis of paroxysmal tachycardia
6. history of myocardial infarction
7. unstable or life-threatening cardiac arrhythmia
8. Hospitalization for heart failure within the past year
9. known active tuberculosis
10. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
11. history of life-threatening pulmonary obstruction
12. history of cystic fibrosis
13. clinically evident bronchiectasis
14. history of significant alcohol or drug abuse
15. history of thoracotomy with pulmonary resection
16. oral or patch ß-adrenergics
17. oral corticosteroid medication at unstable doses
18. regular use daytime oxygen therapy for more than one hour per day
19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
21. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
22. Pregnant or nursing women
23. Women of childbearing potential not using a highly effective method of birth control
24. Patients who have previously been randomised in this study or are currently participating in another study
25. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation
The Efficacy and Safety of Apatinib Combined With Etoposide in Heavily Pretreated Advanced Non-small Cell Lung Cancer

The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). Etoposide is an oral preparation for lung cancer which is recommended by NCCN guideline. The investigators wondered whether these two drugs have synergistic effects when treating advanced non-small cell lung cancer patients who failed to previous at least 2nd line treatments. Thus, the aim of this trial is to investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Obtain of informed consent.
* Histologically or cytologically confirmed non-small cell lung cancer.
* World Health Organization (WHO) performance status (PS) of 0 to 2.
* Measurable lesions as defined by RECIST criteria.
* Second-line or more treatments.
* Wild type of epidermal-growth-factor receptor (EGFR).
* Life expectancy ≥12 weeks.
* Organ functions normal, as defined below, within two weeks of randomization:

  • Hb≥90g/L Absolute neutrophils count(ANC)≥1.5×109/L Platelets≥80×109/L Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT)≤2.5×ULN(≤5×ULN if liver metastases) Creatinine clearance≥45ml/min or Cr≤1.25×ULN.
* Females of child-bearing potential must have negative serum pregnancy test.
* Sexually active males and females (of childbearing potential) willing to practice contraception during the study.

Exclusion Criteria:

* Small cell lung cancer.
* Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
* Uncontrolled hypertension.
* Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
* Abnormal coagulation (INR\>1.5 or PT\>ULN+4, or APTT\>1.5 ULN), bleeding tendency or receiving coagulation therapy.
* Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
* Hemoptysis, more than 2.5ml daily.
* Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
* Unhealed bone fracture or wound for long time.
* Received big surgery, had bone fracture or ulcer in 4 weeks.
* Urine protein≥++, or urine protein in 24 hours≥1.0g.
* Pregnant or lactating woman.
Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography

Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?

Access site complication after coronary angiography is still a challenge in everyday practice. The FemoSeal® closure device has proven very safe as shown in the swedish SCAAR registry. This study is aimed to investigate, in a randomized design, if the FemoSeal® has an advantage in safety and efficacy over manual compression.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be at least 18 years old
* Patients undergoing femoral access coronary angiography
* Patient must be competent for providing informed, written consent
* Only 6F sheath

Exclusion Criteria:

* Percutaneous coronary intervention
* Intra coronary measurements (FFR, IVUS, OCT, NIR)
* Groin hematoma before closure
* Pseudoaneurysm or AV fistula
* Significant stenosis of ilial or femoral artery
* Prior peripheral artery surgery
* INR \> 3,0
* Platelet count \< 120 million per millilitre blood
* Coagulopathy (bleeding disorder)
* Thrombolysis in the last 24h
* Planned heparin infusion after the procedure
* Pregnancy
* Uncontrolled hypertension \> 200 mmHg / 110 mmHg
* Femoral access device closure in the last 30 days
Thulium Contact Laser of Laryngotracheal Stenosis

The purpose of the study is to compare results of the treatment of tumorous and non-tumorous laryngotracheal stenosis using thulium contact laser versus carbon dioxide laser used in the past.

Laryngotracheal stenosis is a serious disease significantly worsening the quality of life. Impaired breathing often leads to tracheotomy, deterioration of the voice leads to communication problems with others and swallowing problems are often present, as well The main causes of laryngotracheal stenosis are post intubation and post tracheostomy conditions, inflammatory process (often autoimmune), tumors (mainly squamous cell carcinoma and chondroma) and trauma. Within the last years there is substantial shift in the treatment strategy from open surgery to endoscopic techniques. However, surgical treatment is often difficult due to demanding exposure of tumor and problematic margins control.

In recent years there has been a development of particular techniques of endoscopic resection of tumors and non-malignant laryngeal glottic and subglottic stenosis using a carbon dioxide (CO2) laser with promising improvement of treatment results.

However, CO2 laser has some limitations, particularly in the treatment of tumors spreading into anterior commissure, because CO2 laser beam cannot get "around the corner". Moreover, subglottic area is also difficult to be reached by CO2 laser beam. Therefore, contact laser with adjustable manipulators with possibility to bend tip of manipulator according to the actual need seems to be of some advantage.

Eligibility Criteria:
Inclusion Criteria:

1. patients with T1-T2 (some T3) laryngeal carcinoma
2. patients with bilateral vocal cord paralysis treated with partial arytenoidectomy and laterofixation
3. patients with subglottic stenosis treated endoscopically

Exclusion Criteria:

* non signing of informed consent
OculusGen-Glaucoma Historical Control Study in Taiwan

The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.

OculusGen® Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

Eligibility Criteria:
Subject inclusion criteria:

1. Age 18 years or over.
2. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
3. Subject able and willing to cooperate with investigation plan.
4. Subject able and willing to complete postoperative follow-up requirements.
5. Subject willing to sign informed consent form.

Subject exclusion criteria:

1. Have allergic reactions to collagen
2. Subject is taking anticoagulation and/or the physician does not suggested to stop taking the medication
3. Normal tension glaucoma patient
4. Subject has one eye received OculusGen™ implantation
5. Subject who been diagnosed infection with the operation eye
6. Subject with anterior chamber abnormality
7. Subject with steroid glaucoma
A Study to Evaluate a Mid Add Multi-Focal Soft Contact Lens

This study is to evaluate the product performance of the investigational LD127025 MF mid add soft contact lens compared to CIBA Vision's Air Optix Aqua MF MED add soft contact lenses when used among currently adapted soft contact lens wearers.


Eligibility Criteria:
Inclusion Criteria

* Have physiologically normal anterior segments not exhibiting biomicroscopy findings Grade 2 or greater and/or presence of infiltrates.
* Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
* Require contact lens correction from -5.00 D to +3.00 D in each eye.
* Be Presbyopic and require near add correction from +1.00 D to +1.75 D in each eye.
* Be an adapted monovision soft contact lens wearer or multifocal soft contact lens wearer or an adapted spherical soft contact lens wearer who also uses spectacles for near vision correction.
* Be willing to use a lens care system as required by the lens replacement schedule.
* Has a distance spherical equivalent refraction between -5.50 D and +3.00 D.

Exclusion Criteria:

* Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
* Participated in any drug or device clinical investigation (within 14 days) prior to entry into this study and/or during the period of study participation.
* Women of childbearing potential if one of the following: pregnant, plans to become pregnant during study, is breast-feeding.
* Any Grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible.
* Any scar or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Anisometropia (spherical equivalent) of greater than 2.00 D.
* Aphakic.
* Amblyopic.
* Allergic to any component in the study care products.
* Meet any of the following criteria:
* Ophthalmologist, OD, Optician, Ophthalmologist's Assistant/Technician
* employee of a market research firm
* employee of manufacturer of contact lens or contact lens care products
* Ocular astigmatism of greater than 1.00 D in either eye.
* Have had any corneal surgery (ie, refractive surgery).
* Toric contact lens wearer.
* Have worn gas permeable (GP) contact lenses within the last 30 days or PMMA lenses within the last 3 months.
* Have an active ocular disease or are using any ocular medication.
* Have any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health during the course of the study.
* Using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial

The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery. The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.

Breast cancer is the most common cancer among women in the world. Although breast-conserving surgery is a viable option for patients, mastectomy remains the choice of treatment. Despite oncologic and surgical safety of nipple-sparing mastectomy(NSM) with immediate breast reconstruction(IBR) were amply demonstrated, a number of acute and late complications can occur. Surgical technique may play a role in the postoperative outcomes of mastectomy skin flap.Previous studies suggest that cold dissection with scissors or scalpel, may lead to decreasing blood loss and rates of skin necrosis, compared to electrocautery. A retrospective study by Troy Ng demonstrated that the use of cold dissection is likely to decrease the rate of partial-thickness necrosis (13.0%→33.3%, p=0.01) and full-thickness necrosis (1.3%→12.8%, p=0.02). The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.

Eligibility Criteria:
Inclusion Criteria:

* Tumor smaller than 5 cm
* No evidence of NAC, skin or chest wall invasion.
* The general inclusion criteria or pre-requisite for nipple sparing mastectomy apply to E-NSM as well.

Exclusion Criteria:

* Patients with apparent NAC involvement, chest wall or skin invasion, inflammatory breast cancer, locally advanced breast cancer or severe comorbid conditions or poor performance status assessed by the primary physicians, such as heart disease, renal failure, liver dysfunction, and poor performance status as assessed by the primary physicians.
Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas

The investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 40-50% in painful non-spinal bone metastases. Additionally, the investigators hypothesize that utilizing a fractionation scheme with an escalated biologically equivalent dose (BED) will result in a higher proportion of participants responding to treatment, and will also lead to more durable responses. Furthermore, the investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 35-45% in painful non-bone metastases

The purpose of this study is to prospectively evaluate dose escalation and pain response in patients with painful non-spinal bone metastases and painful non-bone metastases treated with radiation therapy.

Primary Objective:

To evaluate improvement of complete pain response rate in painful non-spine bone metastases and painful non-bone metastases with dose escalated radiation using a ten fraction radiation regimen

Secondary Objectives:

To evaluate best pain response To evaluate mean pain scores To evaluate the duration of pain response To evaluate the changes in quality-of-life following radiation To evaluate the rates of retreatment with radiation secondary to disease or symptom progression To evaluate treatment related toxicity

Eligibility Criteria:
Inclusion Criteria:

* Have provided signed informed consent for the trial
* Aged ≥18 years at the time of informed consent
* Histologic proof of malignancy
* Radiologic or histologic evidence of bone metastases or non-bone metastases
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≥3
* Pain Score ≥ 3
* Life expectancy of six months or more
* Willing and able to comply with all aspects of the protocol
* A female participant is eligible to participate if she is not pregnant and not breastfeeding
* Woman of childbearing potential who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
* A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment.

Exclusion Criteria:

* Metastasis from a highly radiosensitive tumor (eg, lymphoma, myeloma, germ cell tumor)
* Spinal metastasis
* Active compression of spinal cord/cauda equina
* Previous RT or SBRT to the same site
* \> 3 sites requiring radiation treatment