cyrilzakka/clinical-trials huggingface dataset:
Employment of Patients With Pseudoxanthoma Elasticum

Pseudoxanthoma elasticum (PXE) is a rare, autosomal recessive genetic disease characterized by progressive calcification and fragmentation of elastic fibers in connective tissues. PXE primarily affect the skin, retina and arterial walls. Given the age of onset and progression of the disease, the consequences of PXE affect a large number of patients of working age and are therefore likely to have an impact on their professional career and job retention.

To our knowledge, there are no studies on the occupational impact of PXE.

This is an epidemiological, descriptive and analytical, cross-sectional, monocentric study, carried out by telephone questionnaire on the national cohort of the PXE Reference Center in the Dermatology Department of the Angers University Hospital.

Eligible subjects will be pre-selected by the study investigators on the basis of the medical file. A letter of information about the study will be sent to all the pre-selected eligible patients, with the exception of patients who have expressed an objection to the processing of their data for research purposes.

The investigators will contact eligible patients by telephone approximately 2 weeks after the mailing of the information letter. During this telephone call, the investigator will answer any questions the patient may have about the study and will collect the patient's non-objection to participate in the study and their responses to the questionnaire.

In the absence of a validated questionnaire to meet the objectives of the study, a questionnaire was created.

This questionnaire was tested in order to verify its feasibility and clarity. Medical data (age at diagnosis, age at referral to the Reference Centre, organ damage and clinical manifestations present at the time of the survey, treatments, etc.) will be collected from the medical file and the answers to the questionnaire will be collected by telephone on paper. Data will be collected in a coded manner. A correspondence list will be kept, under the responsibility of the principal investigator.

No follow-up of patients is planned by the study.

The results of this study should make it possible to provide new data on the impact of PXE on the career path and job retention of patients, as well as the medical reasons linked to it. It should also make it possible to improve knowledge on the experience of the consequences of PXE for patients in the workplace, as well as the actors and tools for job retention mobilised in these situations. All of these elements should make it possible to improve the prevention of the professional deintegration of PXE patients, in particular by setting up systematic and early management of patient-workers presenting a declared PXE.

Eligibility Criteria:
Inclusion Criteria:

* PXE
* Working age / Unemployed / Retired less than 2 years

Exclusion Criteria:

* Presence of one or more physical or psychological comorbidity likely to have an impact on the career path and job retention.
* Poor understanding of the french language
* Objection to participating in research
FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML

- To determine the feasibility of fludarabine and cytarabine as continuous infusion plus idarubicin with granulocyte-colony stimulating factor priming for patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia

- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Failure to achieve CR after initial induction chemotherapy including standard dose cytarabine.
* Early relapse, occurring after a first CR lasting less than 12 months.
* Patients with multiple relapses will be included.
* Written informed consent must be given.
* 15 and 60 years of age.
* 2 or less by ECOG performance scale.

Exclusion Criteria:

* acute promyelocytic leukemia
* pregnant or lactating
Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery

The goal of this multicenter randomized controlled trial is to investigate the effect of music prehabilitation on preoperative anxiety in patients undergoing elective oncological colorectal resection. Patients will be asked to listen to music three times a day starting one week before day of surgery. Anxiety levels will be compared with the control group that is not explicitly instructed to listen to music by using validated questionnaires

Perioperative music interventions have been proven to have a positive effect on surgical patients regarding postoperative pain, anxiety and stress. Preoperative anxiety is a predictor for postoperative pain. It is hypothesized that preoperative anxiety develops at home. Unfortunately, data on this subject is scarce. Prehabilitation is a relatively new concept, which improves the patient's condition at home waiting for a surgical intervention. No studies exist in which music is implemented as a prehabilitation method. Music interventions are relatively simple low cost, sustainable and know no side effects. The researchers hypothesize that the use of pre-admittance music interventions as a prehabilitation modality in oncological colorectal surgical patients will decrease preoperative anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 16 years
* Patients undergoing elective oncological colorectal surgery at participating center
* Minimal hospital stay of 2 days postoperatively.
* Sufficient knowledge of the Dutch language
* Communicable and able to assess the questionnaires
* Patients who have access to personal music playing device and headphones/earphones. - Written informed consent acquired from the patient

Exclusion Criteria:

* Patients with severe hearing impairment (defined as no or barely verbal communication possible).
* Patients with an expected stay of less than two nights in the hospital
* Patients who are professional musicians.
* Active music players or singers who may play or sing every week
* Patients who actively listen to music with a duration of \> 30 minutes daily. Active listening is defined as music listening with headphones/earphones, while this is not combined with any other activity (e.g. exercising, working, driving or religious activities).
* Patients who have a preoperative waiting period of less than five days.
* Participation in another study that may possibly intervene with the outcome measures. (e.g. use of psychiatric medication during inclusion or prehabilitation interventions or similar procedures according to the judgement of the research team)
* Assessment of primary outcome is not possible.
* Patients with mental disorders influencing their ability to adhere to the study protocol and/or assess the questionnaires.
* Inability or unwillingness to receive the music intervention.
The Effect of Parathyroidectomy on Renal Function, Endothelial Function, and Blood Pressure

Secondary hyperparathyroidism (HPT) is a known complication of chronic renal failure. Elevated concentrations of parathyroid hormone (PTH) play a role not only in the pathogenesis of renal bone disease, but also in the development of cardiovascular risk factors such as disturbed lipid metabolism, glucose intolerance, and hypertension. HPT is also known to play an important role in the development of structural abnormalities of both large arteries and the heart (left ventricular hypertrophy, interstitial fibrosis). In the last couple of years there has been increasing evidence from animal studies that the endothelium is a target organ of PTH.

Hypothesis: PTH has clinically relevant effects on renal hemodynamics, renal function and endothelial function.

Aims:

1. To evaluate the effect of parathyroidectomy (PTX) on renal hemodynamics in stable renal transplant recipients
2. To evaluate the effect of PTX on endothelial function in stable renal transplant recipients/chronic kidney disease (CKD) stage 5 patients
3. To evaluate the effect of PTX on blood pressure in stable renal transplant recipients/CKD stage 5 patients


Eligibility Criteria:
Inclusion Criteria:

1. Stable renal transplant recipients/CKD stage 5D patients.
2. Age between 18 years and 85 years.
3. Signed informed consent.
4. PTX scheduled because of severe hyperparathyroidism (day 0)
Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)

330 Patients who have completed at least one year of treatment with aflibercept will be randomized to two different aflibercept regimens and followed for 76 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The following criteria must have been met at the initial start of aflibercept treatment (i.e. start of aflibercept treatment at least 1 year before this study):

  * Subject had primary subfoveal choroidal neovascularization (CNV) lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea, as evidenced by fluorescein angiography/photography (FA/FP) of the study eye within 3 weeks before the initiation of aflibercept treatment.
  * The area of CNV occupied at least 50% of the total lesion within 3 weeks before the initiation of aflibercept treatment.
  * Documented best-corrected visual acuity (BCVA) was 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment.
* Men and women \>= 51 years of age
* The subject's history of aflibercept treatment meets ALL of the following:

  * Treatment in the study eye was initiated with three monthly (-1 week/+2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed
  * Following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks

Exclusion Criteria:

- Any prior or concomitant therapy with an investigational or approved agent to treat neovascular AMD in the study eye other than aflibercept.

* Total lesion size \> 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by fluorescein angiography (FA) in the study eye
* Subretinal hemorrhage that was:

  1. 50% or more of the total lesion area, or
  2. if the blood was under the fovea, and
  3. the blood under the fovea was 1 or more disc areas in size in the study eye.
* Scar or fibrosis making up more than 50% of the total lesion in the study eye.
* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
* Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
* Causes of CNV other than AMD in the study eye.
Phase I Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Participants With Colorectal Cancer (MK-0646-016)

The purposes of this study were to assess the safety, tolerability, pharmacokinetic interactions, and the Human Anti-Human Antibody of dalotuzumab in combination with cetuximab and irinotecan in participants with advanced or metastatic colorectal cancer in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Is 20 years of Age or older
* Has a histologically or cytologically confirmed colorectal cancer
* Has previously failed both Irinotecan and Oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy with objective radiological evidence of progression as verified by previous radiologic scans
* Must have adequate organ function

Exclusion Criteria:

* Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to initial dosing on this study or whose toxicities from agents administrated 4 weeks earlier have not resolved to at least grade 1 or baseline
* Has experienced intolerable toxicity to Irinotecan therapy
* Has prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or epidermal growth factor receptor (EGFR) inhibitors (e.g. Cetuximab)
* Is concurrently using growth hormone (GH), Or GH inhibitors
Reproducibility Study of Over Active Bladder Symptom Score [OABSS]

The purpose of this study is to evaluate the reproducibility of over active bladder symptom score (OABSS) in Asian countries.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms OAB for 3 months or longer
* At least 1 urgency episode in last 3 days
* Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

  * Number of micturition ≥8 times/day
  * Number of urgency episode in 3 days ≥1

Exclusion Criteria:

* Indwelling catheters or practicing intermittent self-catheterization
* Symptomatic urinary tract infection, chronic inflammation
* Diabetic neuropathy
A Thorough QT Study of Telotristat Etiprate

The purpose of this study is to demonstrate that telotristat etiprate does not differ from placebo in the mean change from Baseline QT interval corrected for heart rate.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males or females ≥18 to ≤55 years of age (inclusive) at the time of Screening
* Body mass index ≥18 to ≤32 kg/m2 at Screening
* Vital signs (after at least 5 minutes resting in a supine position) at Screening which are within the following ranges: Systolic blood pressure 90 to 140 mm Hg, Diastolic blood pressure 50 to 90 mm Hg, heart rate 45 to 100 beats per minute (bpm)
* Clinical laboratory evaluations (including clinical chemistry panel \[fasted at least 10 hours\], complete blood count, and urinalysis \[UA\]) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator
* Able to tolerate prolonged periods of quiet, motionless, supervised rest
* Willing to adhere to the prohibitions and restrictions specified in this protocol
* Able to comprehend and willing to sign an Informed Consent Form

Exclusion Criteria:

* Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator or Sponsor, may interfere with any aspect of study conduct or interpretation of results
* \>30 premature ventricular beats per hour on the Holter ECG monitoring at Day -1 of Period 1 (monitored at the clinic via telemetry)
* History of additional risk factors for torsade de pointes or the diagnosis or suggestion of a family history of short QT syndrome or long QT syndrome
* History of renal disease or significantly abnormal kidney function tests
* History of hepatic disease or significantly abnormal liver function tests
* History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, or gastrointestinal abnormality
* Concurrent conditions that could interfere with safety and tolerability measurements
* Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens
* Use of tobacco, use of medications, or history of any disease or condition that might interfere with the conduct of the study in the opinion of the investigator
Comparaison of 3 Protocols of Ocytocin Administration in C Section

This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia

This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia.

The aim was to determine the lowest efficient dose to prevent post partum hemorrage and with the lowest incidence of maternal side effects.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients scheduled for C section under spinal anesthesia, monofoetal pregnancy, full term

Exclusion Criteria:

* necessity of general anesthesia
* non conscent
Dyslexics' Visual Attention Field

dyslexia is often considered like a phonological deficit but some researches show that a visual attention (V-A) deficit can occur in dyslexia. The investigator want to show that some dyslexics have a reduced V-A field in visual search when the investigator use separable feature (letter-like).

If the investigator demonstrate that, he will show that V-A deficit can be transpose to an ability acquired before reading, the visual search. Therefore, the V-A deficit can't be a consequence of reading problem but a cause of it for some dyslexics.

The investigator could imagine an earlier diagnosis for children at risk to develop dyslexia and make reeducation more specific for the deficit observed.


Eligibility Criteria:
Inclusion Criteria:

* normal or corrected to normal vision
* diagnosed dyslexics with a recent "alouette" test

Exclusion Criteria:

* other developmental problem (dysphasia, dyspraxia, ADHD)
* strabismus, amblyopia, oculomotor paralysis
Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

The objective of this study is to determine if treating patients undergoing arthroscopic rotator cuff repair with testosterone will allow patients to accelerate their recovery time after surgery.

Specific Aim I:

To determine if testosterone treatment would provide superior patient-determined quality-of-life and activity scores in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery.

Specific Aim II:

To determine if testosterone treatment would allow for greater postoperative strength improvements in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery.

Specific Aim III:

To determine if testosterone treatment would allow for greater postoperative range of motion improvements in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery.

Specific Aim IV:

To determine if the potentially higher activity levels allowed by the testosterone treatment would affect the success of rotator cuff healing as determined by magnetic resonance imaging at one year after arthroscopic rotator cuff repair.

The hypothesis of this study was that testosterone treatment of patients undergoing arthroscopic rotator cuff repair would allow patients to achieve 1) better quality-of-life and higher activity levels as determined by patient-determined outcome scores, 2) greater improvements in strength, and 3) greater improvements in range of motion at three months after surgery as compared to the control group. In addition, the authors hypothesize that there would be equivalent healing rates at one year after rotator cuff repair as determined by magnetic resonance imaging between the testosterone group and the control group.

Eligibility Criteria:
Inclusion Criteria:

* Males
* arthroscopic rotator cuff repair is an indicated treatment

Exclusion Criteria:

* female patients
* irreparable rotator cuff tears
* tears requiring margin convergence repair
* atrophy of the rotator cuff greater than stage II as determined by the modified Goutallier staging system
* revision rotator cuff repair
* inflammatory arthritis
* adhesive capsulitis
* significant cervical pain or radiculopathy
* history of prostate cancer
* history of benign prostatic hypertrophy
* history of heart failure
* history of obstructive sleep apnea
* history of polycythemia
* history of venous thromboembolism or inherited thrombophilia
3D Characteristics, Functional Appliances and Sleep Related Breathing Disorders

Facial scans of the patients eligible for the functional appliance treatment (Twin Block appliance) will be taken prior to and after the end of treatment. Also, a facial scan of the predicted final outcome will be taken, and compared to the actual final outcome. Parents / caregivers will fill out the Pediatric Sleep Questionnaire (PSQ) prior to and upon the end of treatment to asses perceived influence on sleep related breathing problems in their children.

The harmonious growth of the upper and lower jaw enables further favorable development of the orofacial region and the functions of breathing, chewing, swallowing and speaking, as well as the general growth and development of the child. Translation into Croatian and administration of the questionnaire for early detection of sleep disorders related to breathing in children (PSQ) will enable triage and early recognition of children with sleep disorders, which also affect general psycho-physical development. The impact of functional appliance therapy (FA) on changes in craniodentofacial characteristics, dimensions of the upper airway and sleep problems in children will be determined. The non-invasive three-dimensional representation of the face surface provides information about the surface and volume of the observed object, which is used for better diagnostics and therapy planning. Class II is a frequent malocclusion, characterized by a discrepancy of sagittal interjaw relationships. The diagnostic method, which helps in deciding on a therapeutic approach, is the so-called Fränkel maneuver (FM). By comparing the observation of the soft tissue profile of the subjects at rest and after the application of FM, a decision is made on the therapeutic approach. Previous research indicates the validity of using FM in making a decision about FN therapy, with high reliability and consistency. The analysis of latero-lateral (LL) X-ray cephalograms in numerous studies has provided a series of data, which is used, among other things, to assess the remaining growth in order to apply FN therapy in a timely manner, but also to expect a desirable response. The evaluation of the success of therapy based on FM don\&#39;t exist, because a reliable 2D analysis through LL cephalogram would require additional radiation of the subjects. Research indicates that the analysis of scan surfaces is more appropriate than the analysis of anatomical points for detection of the area and amount of changes.

Eligibility Criteria:
Inclusion Criteria:

* retrognathic mandible, increased overjet

Exclusion Criteria:

* craniodentofacial deformities