cyrilzakka/clinical-trials huggingface dataset:
Open-Label Study of Efficacy and Safety of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients With MPS VI

The purpose of the study is evaluate the efficacy, safety, and pharmacokinetics of weekly intravenous infusions of 1 mg/kg recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) in patients diagnosed with Mucopolysaccharidosis VI (MPS VI)


Eligibility Criteria:
Inclusion Criteria:

* Patient consent
* Patient must be five years of age or older
* Patient must have documented biochemical or genetic proof of MPS VI
* Patient must walk at least 1 meter, but less than 250 meters, in the first 6 minutes of the baseline 12-minute walk test
* If female of childbearing potential, patient must have a negative pregnancy test

Exclusion Criteria:

* Patient is under consideration for or has undergone a successful bone marrow transplant (BMT).
* Pregnant or lactating patient
* Patient has received an investigational drug within 30 days prior to study enrollment
* Patient has been previously treated with rhASB
* Patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly confound study results or decrease study compliance
* Patient has a known hypersensitivity to rhASB or to components of the study drug
* History of cancer (except low grade and fully resolved skin malignancy)
Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

The purpose of this study is to assess the efficacy and safety of ReCell grafting after CO2 laser abrasion with superficial full surface ablation, fractional laser treatment and conventional (deep) full surface CO2 laser ablation, to assess the practical aspects and the patient reported outcome and to assess the cellular composition of the graft.

Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating large areas with good cosmetic results. The ReCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) is a device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. With this device an epidermal cell suspension is created from a split skin graft, usually taken from the hip region. Currently, conventional ablative (full surface de-epidermisation) laser treatment in different laser settings is used as pre-treatment to prepare the acceptor site for transplantation. There is no evidence for the laser settings used and no studies are available on the use of a fractional laser as pre-treatment in autologous cell suspension grafting using ReCell (ReCell grafting). The investigators hypothesize that more superficial conventional ablative laser treatment and fractional ablative laser treatment are as effective as the current pre-treatment, whereas these treatments are less invasive, provide faster healing and prevent side effects like persisting erythema and scars. Furthermore, infiltration anaesthesia is not necessary with these less invasive treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patients with, segmental vitiligo or piebaldism under medical treatment at the Netherlands Institute for Pigment Disorders
* Age ≥18
* Patient is willing and able to give written informed consent
* Segmental vitiligo stable since 12 months without systemic therapy or 12 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions.
* At least four depigmented lesions on the proximal extremities or trunk larger than 3x3 cm or one depigmented lesion on the proximal extremities or trunk of at least 12x3 cm.

Exclusion Criteria:

* UV therapy or systemic immunosuppressive treatment during the last 12 months
* Local treatment of vitiligo during the last 12 months
* Vitiligo lesions with follicular or non-follicular repigmentations
* Skin type I
* Recurrent HSV skin infections
* Hypertrophic scars
* Keloid
* Cardiac insufficiency
* Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anaesthesia.
* Patients who are pregnant or breast-feeding
* Patients not competent to understand what the procedures involves
* Patients with a personal history of melanoma or non-melanoma skin cancer
* Patients with atypical nevi.
* Known allergy to clarithromycin
Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers

Alleviation of allergic symptoms induced by house dust mites when using the medical device AM-301.

This clinical investigation explored the efficacy and safety of AM-301 when used to reduce symptoms of house dust mite sufferers. The primary objective was to compare the efficacy of AM-301 Device between treated and non-treated subjects in the treatment of perennial allergic rhinitis (PAR).

This was a randomized, open-label, 3-period crossover study. The total study duration was approximately 65 days and consisted of 2 screening visits and 3 treatment visits (total 5 visits) followed by a telephone call. Patients with HDM allergy as assessed by their medical history and a positive skin prick test for Dermatophagoides pteronyssinus (der p) allergen were enrolled into the screening phase.

At least 7 days after the second screening visit, the treatment visits started. Eligible subjects were randomized to one of the six treatment sequences (ABC, BCA, CAB, ACB, BAC, CBA) at an equal ratio. The treatments were applied 10 minutes before the challenge at Visit 3, 4 and 5:

* Treatment A: One spray AM-301 (0.14 mL) per nostril,
* Treatment B: Two sprays AM-301 (0.28 mL) per nostril (at two defined spray angles in order to obtain a broader coverage of the nasal mucosa),
* Treatment C: no treatment.

The cross-over design allowed treatment C to be used as internal control. Between the three treatment visits in the chamber there was a 7±2 days wash-out period.

Eligibility Criteria:
Main Inclusion Criteria:

* Body mass index between 18.0 and 32.0 kg/m2 inclusive.
* History of perennial allergic rhinitis to house dust mite for more than 1 year.
* Positive Skin Prick Test (SPT) for Dermatophagoides pteronyssinus (der p) allergen at screening or within 12 months prior to the screening visit.

Main Exclusion Criteria:

* Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
* Use of any medication considered to have an influence on the outcome of the study during the EEC session, at the discretion of the Investigator and/or designee.
* Recent nasal ulcers, mucosal erosion, nasal surgery, or nasal trauma, that might interfere with study results as determined by the Investigator and/or designee.
Health Outcomes of Nasopharyngeal Carcinoma Patients Three Years After Treatment by the AI-assisted Home Enteral Nutrition Management

You have completed the current stage of cancer treatment, after which you need to check regularly and pay attention to nutrition. So we started this study to see if AI could help with nutrition management. Main options: Option 1: Use AI to assist nutrition management; Option 2: Contact the nutritionist team of the hospital for nutrition management according to your own situation. Option 3: Do not adopt the first two management methods. Special Statement: Please choose; Cancer screening data is used for statistical analysis, but does not reveal any personal privacy.


Eligibility Criteria:
Inclusion Criteria:

* Malignant tumor patient

Exclusion Criteria:

* no
Satisfaction & Spectacle Independence With ReSTOR 2.5 & ReSTOR 3.0 IOLs

Patients implanted with the ReSTOR 2.5 multifocal IOL in the dominant eye and the ReSTOR 3.0 in the non-dominant eye have overall satisfaction and spectacle independence at least comparable to that with bilateral implantation of the 3.0 add lens. Glare and haloes and other unwanted visual side effects with this mixed combination of lenses is better than with bilateral 3.0 lenses.

Patients desire spectacle independence for a range of distances, including distance, intermediate, and near. The ReSTOR 2.5 multifocal lens has been designed to allow better uncorrected intermediate vision and reduce glare and haloes compared to previous, higher-add models. However, their impact on overall patient satisfaction, glare \& haloes (incidence and impact), and spectacle independence has not been examined with a patient-reported outcome study. Additionally, in clinical practice, many clinicians find that bilateral implantation of ReSTOR 2.5 yields insufficient near vision for about 30% of patients (1). For this reason, many surgeons prefer to implant the ReSTOR 2.5 in one eye (usually the dominant) and the ReSTOR 3.0 in the other eye.

MDbackline is a multi-center patient-reported research engine that has been in use since 2013 for data collection in several patient-reported outcome studies for major industry sponsors. Studies performed with MDbackline have been presented at major meetings and are in press with peer-reviewed journals. The investigators have previously conducted studies of patient satisfaction and spectacle independence with the higher add (3.0) multifocal lens prior to the approval of the ReSTOR 2.5. These data, which include about 85 patients, will be used as historical references. They showed a high degree of satisfaction and spectacle independence but complaints of glare and haloes in as many as 37% of patients ("a fair amount of glare" or more). (2) Since approval of the ReSTOR 2.5, the investigators have clinically observed far fewer complaints of glare/haloes when the lower-add lens is used in at least one eye.

In this study the investigators propose to evaluate patients with the ReSTOR 2.5 lens in one eye and the ReSTOR 3.0 in the other using substantially the same questionnaire in the previous study described above. The investigators plan to compare results of these new data (2.5/3.0 combination) with the previous study data (3.0/3.0).

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with either a ReSTOR 2.5 or 3.0 multifocal within 24 months of the survey administration.
* Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.

Exclusion Criteria:

* Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery
* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
* Patients with previous refractive surgery
* Patients with ≥ grade 1 posterior capsule opacity at their last visit
HemaTrate™ in the Treatment of Critical Limb Ischemia

The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is comparing the percentage of patients between the treatment arm and control arm who have freedom from major amputation, arterial intervention below the knee, and death through 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5)
2. Previously failed an endovascular or surgical treatment of the study lower leg and is not being considered for additional intervention within the next 3 months OR is unsuitable for revascularization

Exclusion Criteria:

1. Simultaneously participating in another investigational study (e.g., drug or device)
2. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months
3. Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days
4. Endovascular intervention within the past 30 days
5. Current dialysis, or expected to need dialysis within the next 12 months
6. Previous above the ankle amputation in the study leg
A Study of Bevacizumab Plus 5-Flurouracil (5-FU) Based Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Previously Untreated Unresectable Liver-Only Metastases From Colorectal Cancer

This open-label, single arm, multicenter study evaluated the resection rate in participants with colorectal cancer and previously untreated unresectable liver-only metastases after adding bevacizumab to 5-FU based doublet chemotherapy in the neoadjuvant setting. Participants receive standard 5-FU based chemotherapy plus Avastin bevacizumab 5 milligrams per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and postoperatively, unless they experienced progressive disease or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Adult Chinese participants, 18-75 years of age
* Histologically confirmed adenocarcinoma in colon or rectum with primary lesion surgically removed
* Previously untreated unresectable liver-only metastases
* Liver lesions determined to be unresectable by multidisciplinary team (MDT, consisting of experienced hepatic surgeons, medical oncologist and radiologist).
* No previous treatment against liver metastases, including chemotherapy, surgery, radiotherapy, Transarterial chemoembolisation therapy (TACE) and target therapy
* Adequate hematological, renal and hepatic function
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Life expectancy greater than (\>) 3 months

Exclusion Criteria:

* The relapse has occurred within 6 months of completion of the adjuvant treatment
* Expected impossible to achieve complete resection (R0 resection) and/or gain 30% residual liver volume even with responsive neoadjuvant therapy
* Participant cannot tolerate the surgery
* Other malignancies in the past 5 years, except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
* Any extrahepatic metastases and/or recurrence of the primary tumor
* Any residual toxicity from previous chemotherapy (except alopecia) of National Cancer Institute Common Toxicity Criteria (NCI CTC) v.4.0 grade 2
* Hypertension crisis or encephalopathy
* Pregnant or lactating women
* Clinically significant cardiovascular disease
* Evidence of bleeding diathesis or coagulopathy
* Current or recent (within 10 days of study drug initiation) use of full dose of aspirin, clopidrogel or warfarin
* History or evidence of Central Nervous System (CNS) disease (for example, primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)
Predictors of Attempted Inferior Vena Cava Filters Retrieval.

The InferiorVena Cava (IVC) with filters has been recommended when there is a contraindication or a failure of anticoagulation. Due to the side effects related to the filters, it is recommended to remove them as soon as possible. It's a retrospective study in a French hospital to evaluate the retrieval rate and predictors of filter removal.

All the data of consecutive patients who had a retrievable InferiorVena Cava Filter (IVCF) inserted in the investigator center between April 2012 and November 2019 are included.


Eligibility Criteria:
Inclusion Criteria:

* patients who had a cave filter placement at Saint-Etienne Hospital between april 2012 and november 2019.

Exclusion Criteria:

* None
Validating a Delirium Prediction Model for Critically Ill Patients

The objective of this study is to determine the incidence of delirium in adults patients who are admitted at the critical care unit of a Dutch University Hospital with the mapping of relevant delirium risk factors The primary aim is to validate the investigators' developed delirium prediction model for critical care patients.

A secondary aim is to find differences between delirious patients and non-delirious patients on different aspects of diagnostics, treatment and care, outcome, length of stay, and inflammation.

According to Dutch law, the need to obtain informed consent was waived by the Committee on Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).


Eligibility Criteria:
Inclusion Criteria:

* all adult patients (18 years and older) admitted at the critical care unit of our hospital

Exclusion Criteria:

* admitted \< 12 hours on ICU
* not able to understand Dutch
* patients with serious hearing and visibility disabilities
* mentally retarded patients
* patients suffering from receptive aphasia
* delirious before admission
Medical Imaging Screening for Posterior-circulation Ischemic Stroke

Patients with ischemic stroke in the posterior circulation continue to have high rates of mortality and disability, even with aggressive treatment. We wanted to evaluate preoperative imaging to screen patients with a good prognosis from mechanical embolization. We assess the degree of ischemia by defining the pons-midbrain-medulla index (PMMI) and correlate the preoperative PMMI with the clinical prognosis of postoperative patients to verify the validity of PMMI in predicting the clinical prognosis of patients with embolization.

* The ENDOSTROKE registry (Endovascular Stroke T reatment Registry), the use of MRI before EVT was associated with significantly better clinical outcomes as compared to CT.
* The purpose of the study will sift patients with posterior circulation ischemia stroke who will get better outcome by Mechanical Thrombectomy by neuroimaging.Specifically, the following assumption will be evaluated: the modified pons-midbrain index in magnetic resonance imaging can predict the clinical outcome of patients with basilar artery thrombosis 90 days after surgery, and can guide whether patients will undergo mechanical thrombectomy later.
* Pons-midbrain-medulla index (PMMI) : We divide pons-midbrain-medulla into the left and right sides by the median line of the brainstem,so we will evaluate ischemia of these six layers which are endowed different score according to the degree of ischemia. Instead of the previous pons-midbrain index (PMI), we select the image layer that shows the largest infarct size among the six parts.Then,we add up six scores that is patient's PMMI. Scoring criteria: At the layer of displaying the maximum infarct size, 2 points are scored if the infarct size exceeds 50% of the total area, 1 point is scored if the infarct size is less than 50% of the total area, and 0 points are scored if there is no infarct.Finally, PMMI values range from 0 to 12 points.
* The investigators conduct a multicenter, prospective cohort study.Preoperative images of patients are evaluated by different groups of imaging physicians to describe the association between preoperative PMMI and clinical prognosis in patients with posterior circulation stroke and to verify its validity.

Eligibility Criteria:
Inclusion Criteria:

1. Patient admitted from Jun. 1st 2019 to Jan. 1st 2029;
2. Patients with acute ischemic stroke recently；
3. Symptoms persisted at admission, and MRI (including DWI) confirmed acute ischemic vertebrobasilar artery occlusion in the posterior circulation:（single right or left intracranial branch of vertebral artery occlusion ; single basilar occlusion ; both two vertebral arterys and basilar artery）；

Exclusion Criteria:

1.Patiens can not meet the MRI examination conditions(with absolute and relative contraindications).
Dual Task Training in Parkinson's Disease

The aim of study is to analyze the effects of dual task training on balance, gait, cognition and neurotrophic factors in Parkinson's disease.

20 patients diagnosed with Parkinson's disease will be randomly assigned to either intervention or control group. And 10 healty subjects will be included to study in order to determine the reference values.The intervention group will be recieved cognitive and motor dual task training consisting of balance and walking activities 3 days a week for 8 weeks. Control group will be recieved same balance and walking activities in single task condition 3 days a week for 8 weeks. In order to evaluate the effects of the training, evaluations will be performed before and after the training period.

Eligibility Criteria:
Inclusion Criteria:

* at least 40 years of age
* neurologist-diagnosed Parkinson's Disease
* Hoehn \& Yahr (H\&Y) stages 1 to 3
* 24 or more mini mental status examination score.

Exclusion Criteria:

* other neurologic disorder
* cardiovascular, inflammatory,vestibular or musculoskeletal problems that could prevent them to participate in an exercise program
* had deep brain stimulation history
* visual, auditory, orientational problems that could affect study results
Total Temporomandibular Joint Replacement System Post Approval Study

Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data \[PMA P020016\]

An additional three-year follow-up data will be collected on subjects previously enrolled in the PMA study, who had not completed follow-up prior to the PMA approval \[PMA P020016\].

Eligibility Criteria:
Inclusion Criteria:

1. Patients requiring total joint reconstruction due to:

   Arthritis (osteoarthritis, rheumatoid, traumatic) malignancy Ankylosis functional deformity Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints
2. Patients who are skeletally mature.
3. Patients must have at least one of the following criteria for surgical TMJ treatment.

   1. Presence of considerable pain and/or limited function in the joint area.
   2. Clinical and imaging evidence consistent with anatomic joint pathology
   3. Previous failure of non-surgical treatment/therapy or a failed implant.
   4. High probability of patient improvement by surgical treatment.
4. Patients must be able to return for follow-up examinations.
5. Patients without serious compromising general medical conditions.

Exclusion Criteria:

1. Patients with active infection.
2. Patient conditions where there is insufficient quantity or quality of bone to support the device
3. Patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component.
4. Patients with mandibular and/or zygomatic arch screw holes compromising component fixation
5. Patients requiring partial joint reconstruction or other TMJ procedures not listed as an indication.
6. Patients who are NOT skeletally mature.
7. Patients who are incapable or unwilling to follow postoperative care instructions.
8. Patients who are unable to return for follow-up examinations.
9. Patients with severe hyper-functional habits
10. Patients on chronic steroid therapy.