cyrilzakka/clinical-trials huggingface dataset:
Open-Label Extension Study of Recombinant Human Arylsulfatase A (HGT-1111) in Late Infantile MLD

This is a multi-center, open-label, extension study of patients with late infantile MLD who have previously completed clinical study HGT-MLD-048 (NCT00633139), defined as the completion of all Week 52 procedures. This group of patients will be offered ongoing treatment with HGT-1111 in this protocol. One infusion will be given every other week until the product is commercially available, the patient discontinues, or the study is terminated by the Sponsor, provided no safety issues have emerged.

The primary objective of this study is to provide ongoing treatment of HGT-1111 to patients who have completed study HGT-MLD-048 (previously study rhASA-03 - NCT00633139) until HGT-1111 is commercially available or the study is terminated by the Sponsor, provided no safety concerns have emerged. The secondary objective of this study is to monitor disease progression and the safety profile of HGT-1111 administered to patients who have completed study HGT-MLD-048 (NCT00633139).

Eligibility Criteria:
Inclusion Criteria:

1. Subject's legally authorized guardian(s) must provide signed, informed consent prior to performing any study-related activities (Trial-related activities are any procedures that would not have been performed during normal management of the subject)
2. Completion of study HGT-MLD-048 (NCT00633139)
3. The subject and his/her guardian(s) must have the ability to comply with the protocol

Exclusion Criteria:

1. Spasticity so severe to inhibit transportation
2. Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical condition that, in the opinion of the Investigator, would preclude participation in the trial
3. Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial
Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device

The aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD).


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients under 6 years of age who are scheduled simple operation under general anesthesia
* SAD was used for mechanical ventilation

Exclusion Criteria:

* Abdominal distension, risk of pulmonary aspiration
* Bronchopulmonary dysplasia/respiratory distress syndrome
* Pneumothorax
* Airway surgery
* Thoracic surgery or laparotomy
* Surgery under prone position
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium

Assess Cryoablation (CryoBalloon Ablation cryotherapy) for treatment of Dysplastic Barrett's Esophagus, Esophageal Squamous Dysplasia and early Esophageal Cancer. The cryoablation treatment will be offered as an alternative to standard ablation therapies such as Radiofrequency Ablation, Argon Plasma Coagulation and carbon dioxide Cryotherapy).

Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The purpose of this study is to assess the safety, feasibility and performance of cryoablation system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous dysplasia who need ablation therapy for clinical standard care. The new cryoablation treatment will be offered as an alternative to standard ablation therapies already in place (radiofrequency ablation, carbon dioxide cryotherapy).

Eligibility Criteria:
Inclusion Criteria:

* Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy.

Exclusion Criteria:

* Patient unable to undergo endoscopy,
* Patients with visible esophageal mass.
Assessment of the Efficacy of Stereotactic Intracavitary Instillation of 90Yttrium Colloid

Neuroepithelial cysts are rare, representing less than 1% of the intracranial cysts. Neuroepithelial cysts, are benign and mostly asymptomatic. These cysts are lined by thin columnar or low cuboidal epithelium. The CSF-like contents of the cyst are due to secretion of the epithelial cyst wall. Although mostly asymptomatic, symptoms can occur when the cyst enlarges; the specific symptoms vary according to the size (mass effect) and location of the lesion. Radioactive phosphorus (32P) and 90yttrium colloid are isotopes that have been used. These are approved in the United States and Europe. 32P is not available in Canada. We want to use 90yttrium colloid. There is evidence in the scientific literature that treatment with 90yttrium colloid injected into the cyst is effective in preventing the cyst from growing, effective in causing the cyst to get smaller and in some cases the cyst disappears.

In brief, a single patient has been identified as having a cystic tumor by diagnostic imaging and clinical expertise and based on standards of excellence in clinical care will be offered participation in the study for the intracystic implantation of 90yttrium colloid. This patient will be followed closely for 4 weeks following 90yttrium colloid treatment and then receive standard of care (http://neurosurgery.medicine.dal.ca).

Eligibility Criteria:
Inclusion criteria:

1. Cystic tumor
2. Required treatment
3. Adult over 17 years of age
4. Willingness to provide informed consent

Exclusion criteria

1. Solid tumor
2. Treatment not required
3. Child under 17 years of age
4. Not willing to provide informed consent
Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life

Diabetes is a chronic and progressive disease that affects nearly 3.5 million people in France.

Currently the investigators are seeing an aging of the population explained by the increase in life expectancy and thus an increasing incidence of diabetes in the elderly. However, the frequency of hypoglycemia in older vulnerable patients remains poorly characterized


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 75 years of age;
* Type 2 diabetes for at least 1 year and treated with insulin for at least 6 months;
* Treated with basal insulin (ie glargine U100: Lantus®, Abasaglar®, glargine U300: Toujeo®, detemir: levemir®, NPH), premix (ie Novomix® and Humalog Mix®), and / Insulin associated or not with one or more oral and / or injectable antidiabetic agents (analog of GLP1...);
* Benefiting from at least 1 capillary glucose per day (carried out by the patient himself or a caregiver);
* Benefiting from a standardized geriatric assessment;
* Signature of informed consent
* Patient benefiting from a social security system.

Exclusion Criteria:

* Male or female aged \<75 years;
* Person without diabetes or type 1 diabetes;
* Patient treated only lifestyle modifications and / or oral anti-diabetic drugs and / or GLP-1 receptor agonists alone;
* Subjects with secondary or corticosteroid-induced diabetes;
* Refusal to participate in the study or inability to collect consent;
* Patient for whom follow-up of the study procedures is impossible (glycemic record impossible or insufficient);
* Patient not eligible for geriatric assessment;
* Patient already participating in another study;
* Patient with a severe pathology limiting his life expectancy (palliative care ...) compromising his participation in the study at the discretion of the investigator;
* Patient benefiting from a safeguard of justice.
Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy

The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season.


Eligibility Criteria:
Inclusion Criteria:

* allergic to ragweed

Exclusion Criteria:

* not allergic to ragweed
* history of anaphylaxis
* subject with chronic sinusitis, unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological disease
* Asthmatic subjects with FEV1 or PEF less than or equal to 80% predicted
* Subjects who have received experimental drug within 30 days prior to study admission
* Subjects who have received anit-IgE medications in the last 12 months
* Subjects who have received ragweed immunotherapy in the last 3 years
* Subjects who are currently users of inhaled, intramuscular, or intravenous corticosteroids, tricyclic anti-depressants, beta blockers, and MAO inhibitors
* Subjects refusing to sign epi-pen training form
* Females who are pregnant or breast feeding
Implantable Systems Performance Registry

The Implantable Systems Performance Registry (ISPR) was developed to evaluate the long-term reliability and performance of market-released Medtronic Neuromodulation infusion and stimulation products.

Completion Notice: The ISPR was created by Medtronic to monitor the performance of commercially available products. This registry was initially designed to track performance of Medtronic's implantable infusion and spinal cord stimulation systems beginning in August 2003 and June 2004, respectively. Medtronic DBS Systems were added to the ISPR in June 2009, and Sacral Neuromodulation Systems in April 2010. Medtronic retired the ISPR in April 2016 and merged the data collected from this registry into the Product Surveillance Registry (PSR). Please refer to that record, Clinical Trials identifier: NCT01524276, for further information.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an implant or replacement with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator

Exclusion Criteria:

* Patient who is or will be inaccessible for follow-up at an ISPR study site
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).


Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.

Exclusion Criteria:

* Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
* Enrollment in other studies using Bimatoprost SR.
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions

The primary objective of this study is to evaluate long-term effectiveness of adalimumab in pediatric participants starting a treatment for Crohn's disease in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach. Main secondary objectives are to describe growth and pubertal development and to describe long-term safety. The participants will be followed-up up to 10 years.


Eligibility Criteria:
Inclusion Criteria:

* With confirmed diagnosis of Crohn's disease
* Adalimumab-naïve patient (a patient having received an anti-TNF other than adalimumab may enter the study)
* Starting a treatment with adalimumab
* Guardian capable of and willing to grant authorization for use/disclosure of data collected and patient able to comply with the requirements of the study protocol.

Exclusion Criteria:

* Participants with a history of treatment with adalimumab
* Participants enrolled in a concomitant interventional clinical trial.
Clinical Study To Assess The Safety, Parameters And Efficacy For Procedures Using A Radiofrequency Device

The purpose of this study was to develop parameters and assess the safety of the radiofrequency device for a variety of treatments. Treatment results were also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female 18 years of age or older.
* Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
* Understands and accepts the obligation and is logistically able to be present for all visits.
* Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria:

* Is pregnant or of child bearing potential and not using medically effective birth control or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the course of the study.
* The subject has active or localized systemic infections.
* The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
* Any other types of cosmetic treatments in the area to be treated in the past 6 months are cautioned and determined at the discretion of the investigator.
* The subject has a history of keloids.
* The subject has evidence of active systemic or local skin disease that may alter wound healing.
* The subject has scarring or wounds in the treatment area that would interfere with study assessments.
* The subject has a metal implant (such as but not limited to; titanium orbit or metal chin repair) in the face or head that would interfere with study treatment, or subject has an electronic implantable device (such as but not limited to; pacemakers and embedded defibrillators).
* The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
Recurrence in Buccinator Muscle Excision With the Skin Versus Without the Skin in Buccal Squamous Cell Carcinoma

Evaluation of local control in buccinator muscle excision with the skin versus buccinator muscle excision without the skin in buccal squamous cell carcinoma: A randomized clinical trial.

Preoperative Multi Slice CT scan or MRI carried out for evaluation the lymph node of the neck. Also, ultrasound carried out for measuring the depth of invasion of the tumour in the cheek (The invasion in the buccinator muscle).

* Under general anaesthesia, the buccal squamous cell carcinoma which invaded the buccinator muscle will be excised with the skin of the cheek. This will be done by a safety margins in the soft tissue and the mandible may be resected according to the plan and the invasion of the tumour.
* A neck dissection will be done in all cases of negative or positive neck lymph node.
* Reconstruction of the soft tissue will be done immediately by a major pectorals flap with the skin, also bony reconstruction may be done by a reconstructed plate at the time of surgery then the patients will be prepared for bone graft in another surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from buccal squamous cell carcinoma.
* Patients should be free from any systemic disease that may affect normal healing, and predictable outcome.
* Both sexes and all ages will be included in the study.
* Cooperative patients, who accept the procedure and return for follow up , examination and evaluation.

Exclusion Criteria:

* Patients with any systemic disease that may affect normal healing.9,10
* Patients who physically and psychologically not able to tolerate the procedures.
* Patients may discontinue the follow up.
Post-Approval Study of the TREO Abdominal Stent-Graft System

The purpose of this study is to determine the long-term performance of the TREO Abdominal Stent-Graft as a treatment for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms.

This is a prospective, multi-center, non-randomized, single-arm, post-market, non-interventional study of treatment with the TREO Abdominal Stent-Graft in subjects with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms. The study will include a minimum of 300 subjects treated with the TREO Abdominal Stent-Graft at up to 55 investigational sites in the US.

The primary objective is the collection of real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of AAA in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with all study procedures and visits.
* Written informed consent to participate in the study.
* Patient's aneurysm can be treated with the TREO Abdominal Stent-Graft System.
* Adequate data (medical records/imaging studies) available to analyze the primary endpoints for patients enrolled retrospectively.

Exclusion Criteria:

• Medical, social or psychological problems that, in the opinion of the investigator, preclude patient from receiving treatment with the TREO Abdominal Stent-Graft System.
Sound Ear Check (SEC) in Hearing Diagnostics in Young Children

Study Sound Ear Check (SEC) hearing test among 3-10 years old otherwise healthy children referred to tympanostomy tube placement. SEC test prior surgery (with middle ear fluid) and at 1 month control visit (dry middle ear with ventilation tube). Otitis media 6 questionnaire prior surgery and at the 1 month control visit.

Sound Ear Check (SEC) is an automated tablet-based self-test that uses common nonspeech sounds (ecological sounds) that are accompanied by pictures that are easily recognizable even for younger children.

Before TTI operation, each participant will be tested with SEC using normal (dichotic) sounds and antiphasic sounds. Results will be compared to middle ear findings and the test will be repeated one month after the operation when the middle ears are checked to be dry (with a ventilation tube). At the time of the myringotomy during TTI operation, possible middle ear fluid will be classified as serous (transparent, clear), mucous (thick) or purulent (consisting of pus). A tympanometry will be performed within the same visit as the SEC measurement before the TTI operation. At the time of tympanometric examination, each participant will be classified as cooperative (sittings still, not crying, not resisting) or non-cooperative. Tympanometric findings will be classified after the Jerger classification. SEC and tympanometric testing is designed to be performed at the same visit as TTI operation as patients will be waiting for the operation at the ward. Medical history of the study patients will be collected from the hospital patient records and through interview and questionnaires to the subjects. Ear related quality of life questionnaire (OM-6) will be performed at the beginning of the study and the one month control visit. Questionnaires are collected using web-based REDCap -software (Research Electronic Data Capture).

Eligibility Criteria:
Inclusion Criteria:

* Finnish speaking (child and parent)

Exclusion Criteria:

* Prior sensorineural hearing loss
* developmental disorder
* Prior ear surgery (except tympanostomy insertion)
Chinese FPD Registry

The purpose of the Chinese Familial Parkinson's disease Registry (CFPDR) is to develop a database of patients with familial Parkinson's disease (PD) in China.

Parkinson's disease (PD) is the second most common disorder among degenerative neurological disease. Familial PD (FPD) has its unique clinical feature and genetic basis. We aim to establish a database of FPD,and characterize the clinical feature, genetic basis, environmental factors and their interactions FPD in China.

Method:

1. Clinical feature will be measured by scales and neurological tests.Standard scales includes: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, NMSS, MMSE, PDSS(Parkinson disease sleep scales),Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK),ESS(Epworth Sleepiness Scale),Rome III functional constipation scale，SCOPA-AUT (the Scale for Outcomes in PD for Autonomic Symptoms)，PFS(Parkinson Fatigue Scale)，CH-RLSq，Hyposmia rating scale(HRS)HAMILT depression scale，the 39-item Parkinson's Disease Questionnaire(PDQ-39)，Freezing of gait scale(FOG)，dyskinesia related scales, Wearing-off scale(WO)
2. Peripheral blood from patients and other members in family will be collected for familial PD genetic testing.
3. The environmental factors are exploded by questionnaires including smoking,drinking, pesticide and heavy metals.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease, and either family history of Parkinson's disease (first or second degree family member affected by Parkinson's disease) AND/OR Clinical diagnosis of Parkinson's disease and their parents are close relatives(First or second degree family member of an Index Case, affected or unaffected by Parkinson's disease).

Exclusion Criteria:

* Lack of capacity to consent to participate in the project
Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA)

The aim of this study was to assess the effects of a 5-week standardized cognitive behavioral treatment of stress management conducted via e-learning or face-to-face on patients responding to the diagnosis of adjustment disorder with anxiety (ADA) according to the DSM- 5 (Diagnostic and Statistical Manual of Mental Disorders Fifth Edition) criteria .

The program includes 5 weekly sessions that the patient follows. It is based on standard CBT (Cognitive Behavioural Therapy) principles and includes five modules (information about stress and stress reaction and assessment; deep respiration and relaxation techniques; cognitive re-structuration; mindfulness and acceptation; behavioral skills as solving problem, time management, healthy behaviors, problem solving and emotion regulation ...).

* In internet-based group patient benefits from a minimal contact with a medical member of staff before and after every session. It is supplied to the patient, from the first session an USB key containing videos, audio files, help-self book portfolio in the form of e-guide, log books with the program of the exercises to be realized between two session of the 5 sessions program. The patient is encouraged to practice a twenty-minutes daily of exercises five or six days per week.
* In face-to-face group, patient receive the same program with a therapist in 5 weekly sessions without digital supports.

Eligibility Criteria:
Inclusion Criteria:

* Adjustment disorder with anxiety (ADA) according DSM-5 (The diagnosis was made according to the MINI questionnaire).
* Subscore anxiety \> 10, subscore depression \< 10 at Hospital Anxiety Depression Scale (HADS)
* Computer at home

Exclusion Criteria:

* Subscore anxiety \< 10, subscore depression \> 10 at Hospital Anxiety Depression Scale (HADS)
* No others current psychiatric diagnostic according DSM- 5
* No suicidal ideation
Measurement of Cerebral Oxygenation Using NIRS Method in the Preterm Infants With Intracranial Haemorrhagia

The aim of the study was investigated the cerebral tissue oxygenation index (c-TOI) measured by near infrared spectroscopy (NIRS)in the preterm infants with intracranial haemorrhagia.


Eligibility Criteria:
Inclusion Criteria:

.\<34 gestation week preterm infants with intracranial haemorrhagia

Exclusion Criteria:

* sepsis
* NEC
* congenital abnormalities
* hydrocephalus
* intracranial infections