cyrilzakka/clinical-trials huggingface dataset:
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)

A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs. without subclinical leaflet thrombosis at five years after TAVI; and between patients with intra-annular vs. supra-annular TAVI prostheses.

Subclinical leaflet thrombosis (SCLT) occurs frequently after TAVI and has been associated with an increased risk of valve dysfunction. A persistent form of SCLT may lead to thrombus calcification and valve degeneration and increase the long-term risk of symptomatic bioprosthetic valve deterioration. Intra-annular in comparison to supra-annular TAVI valves have been associated with a higher risk of SCLT and valve thrombosis. Intra-annular valves may create larger neo-sinuses and flow stagnation zones, which favour local thrombogenicity. Whether different prosthesis types lead to a higher degree of transcatheter valve calcification and degeneration is currently unexplored. Recently, 18F-sodium fluoride (18F-NaF) positron emission tomography (PET) has emerged as a non-invasive modality capable of imaging bioprosthetic micro-calcification activity, which is an early and powerful predictor of valvular dysfunction and eventually valve failure. In the present study, we investigate for the first time, the differences in quantified bioprosthetic micro-calcification activity with 18F-NaF PET as early marker of transcatheter valve degeneration between patients with and without SCLT and between patients with intra-annular vs. supra-annular prostheses at five years after TAVI.

Eligibility Criteria:
Inclusion Criteria:

* Successful TAVI with Sapien or CoreValve Evolut prosthesis about 5 years ago
* Able to undergo hybrid 18F-NaF PET-CT imaging and transthoracic echocardiography
* Written informed consent

Exclusion Criteria:

* Temporary or chronic oral anticoagulation use after TAVI
* Known severe renal insufficiency
* Known severe paravalvular regurgitation
* History of valve-in-valve procedure
* History of aortic valve re-intervention (including percutaneous paravalvular leak closure)
Reliability of Functional Outcome Measures in Plantar Fascitis Patients

Plantar Fasciitis (PF) is the most common foot condition treated by healthcare providers, striking approximately 2 million Americans each year. Nevertheless its causes are still not known. The risk factors for PF are known and the diagnosis, which is based on clinical assessment, is relatively simple. Still most of the treatments for PF focus on short term symptoms relief instead of prevention or reduction of recurrence.

Physical therapy treatment that focuses on reducing the symptoms for the long run and prevention, should include outcome measures, which if found to be reliable, will make the diagnosis clearer. Diagnosis based on reliable clinical and functional measures will assist the physical therapist to understand the major deficiencies of the patient, and accordingly to help him to make the right decision in choosing treatment. Also comprehensive knowledge of the characteristics of PF may enable selection of appropriate preventive measures.

Objectives:

Characterize the unilateral PF syndrome using functional outcome measures, while comparing them to the healthy foot of the same patient. In addition the study will investigate the reliability of these functional outcome measures in PF patients.

Methodology:

Individuals referred to physiotherapy for PF will be assessed for eligibility and consent for the study. They will undergo two evaluations on the same week to evaluate the test- retest reliability of the functional measurements.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral plantar fasciitis
* Painful first step in the morning
* Calcaneal soreness in palpation
* Insured by Clalit Health Care Services
* Signed informed consent

Exclusion Criteria:

* Ankle or foot surgery
* Congenital deformation of foot
* Lower limb spasticity
* Using assistive devices
* Bilateral plantar fasciitis
* Refuse to participate or sign informed consent
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications

Primary Objective:

To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c).

Secondary Objectives:

To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:

* Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event from 22:00 to 08:59 next morning
* Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL \[3.9mmol/L\]) hypoglycemia event
* Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event occurring at any time of day
* HbA1c change

The study consisted of a 4-week screening period, a 26-week treatment period comparing HOE901-U300 to Lantus, and a 2-day safety follow-up period.

Eligibility Criteria:
Inclusion criteria:

* Participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
* Signed informed consent.

Exclusion criteria:

* HbA1c at screening visit:

  * \<7.0% or \>10.0% for participants taking basal insulin.
  * \<7.5% or \>11.0% for insulin-naïve participants.
* History of type 2 diabetes mellitus for less than 1 year before screening.
* Participants not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
* Change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
* Chronic (\>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, e.g. premix insulin; For insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
* Cognitive disorder and dementia assessed clinically and by Mini-Mental State Examination (MMSE) score \<24, or any neurologic disorder that would likely affect the participant's ability to follow the study procedure. The participant would be eligible despite an MMSE score \<24 if the investigator determined that the low score reflected educational or cultural background and not dementia as long as the participant was otherwise able to meet the study requirements.
* Participants who had end-stage renal disease (\<15 mL/min/1.73m\^2, per estimated Glomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease (MDRD).

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn

Esophageal hypersensitivity/Functional heartburn are common among non-erosive reflux disease (NERD) patients who do not response to proton pump inhibitors. Whether tricyclic antidepressant improves NERD patient's symptoms remains unknown

Aim of this randomized controlled trial study is to determine the efficacy of imipramine, which could increase esophageal pain thresholds in healthy volunteers, in comparison with placebo for treatment patients with esophageal hypersensitivity or functional heartburn evaluated by improvement of specific-symptom score and quality of life


Eligibility Criteria:
Inclusion Criteria:

* patient with typical reflux symptoms (heartburn and/or regurgitation) more than 3 times per week in at least last 3 months
* Age more than 18 years
* Upper GI endoscopy showed no esophageal mucosal breaks
* MII-pH monitoring was not showed abnormal both acid and non-acid reflux
* symptoms was not improved after received standard dose proton pump inhibitor for at least 1 month

Exclusion Criteria:

* history of thoracic, esophagus, or stomach surgery
* severe esophageal motility disorder eg. Achalasia, scleroderma, autonomic/peripheral neuropathy/myopathy
* patient who was indicated to receive proton pump inhibitor
* pregnant women
* patient who was allergy to imipramine
* patient who received tricyclic antidepressant or SSRI with in 3 month of enrollment
Laterally Closed Tunnel VS Tunneling Technique in Recession Type 2

This study aims to assess the effect of tunneling technique with subepithelial connective tissue graft versus tunneling technique with laterally closed tunnel in treatment of recession type 2 defect.Few randomized clinical trial has been involved with recession type 2 defects treated with tunneling technique and coronal advanced flap.

Tunneling with subepithelial connective tissue graft:

At the recipient site (recession defect):

After scaling and root planning. A sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.

At donor site (palate):

A connective tissue graft is harvested from the palate after administration of local anesthesia using a partial thickness flap which will be raised with single incision.

Then the graft is placed and secured in the recipient site using suture. The flap is displaced to be in a coronal position using a suture.

Tunneling technique with the laterally closed tunnel):

After local anesthesia, root planing of the exposed root surface will be performed. An intrasulcular incisions will be made creating a tunnel extending to the mucogingival line and mesial and distal recession defects while keeping the interdental papilla intact as well as not perforating the flap.

* Donor SCTG Subsequently, a palatal SCTG will be harvested by means of the single incision technique with immediate closure of the donor site.
* Recipient site; Using either single or mattress sutures, the SCTG will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Finally, the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older.
* Patients with healthy systemic condition
* Buccal recession defects with recession type 2 defects.
* Clinical indication and/or patient request for recession coverage.
* O'Leary index less than 20%

Exclusion Criteria:

* Pregnant females.
* Smokers as it is a contraindication for any plastic periodontal surgery
* Unmotivated, uncooperative patients with poor oral hygiene
* Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.
Human Amniotic Membrane and Mesenchymal Stem Cells Composite

The purpose of this clinical trial is to investigate the utility of composite wrapping comprising human amniotic membrane and allogeneic adipose-derived mesenchymal stem cells (HAM-AdMSC) for augmentation of nerve transfer procedure in upper TBPI patients

Nerve transfer procedure is recognized as the current gold standard for treating traumatic brachial plexus injury (TBPI). However, despite the current major progress in diagnosis and microsurgical repair, the prognosis in TBPI remains unfavorable due to limited donor nerve and compromised regenerative capability of the nervous system arising from prolonged denervation. Therefore, there is a major need to devise new treatment strategies; and one possible approach is to develop cellular therapies to bioengineer new nerve tissue and/or modulate the endogenous regenerative mechanisms within the injured nerve.

Our previous studies have shown that the peripheral nerve tissue engineering approach using human amniotic membrane seeded with allogeneic adipose-derived MSCs to augment axonal regeneration in nerve transfer of TBPI patient revealed promising functional recovery of the shoulder range of motion (ROM). The investigators plan a non-randomized clinical trial in a single center to investigate the use of a hybrid (composite) between human amniotic membrane (HAM) and allogeneic adipose-derived mesenchymal stem cells (AdMSC) as wrapping in the nerve transfer procedure of upper TBPI patients, with a focus on the augmentation of axonal regeneration

Eligibility Criteria:
Inclusion Criteria:

* Suffering from upper BPI (C5-C6 and/or C5-C7) for a duration of fewer than 12 months
* Have no systemic disease (Diabetes Mellitus, Lupus erythematosus, rheumatoid arthritis)
* Without prior medicamentous treatment history such as corticosteroids
* Agree to contribute in the study

Exclusion Criteria:

* Complete BPI (C5-Th1), lower BPI (C8-Th1)
* Traumatic BPI associated with delayed/non-union fracture of the upper extremity affected side.
* Polytrauma conditions which are not fully recovered
A P300 Brain Computer Interface to Operate Power Wheelchair Tilt

The investigators want to develop a brain-computer interface (BCI) that will eventually allow people who are completely paralyzed to independently control the tilt feature on their power wheelchairs. This study will allow healthy volunteers to test the feasibility and accuracy of controlling a BCI using only their brain signals while seated in a tilting wheelchair.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Able to read text on a computer screen
* Able to understand and remember instructions concerning participation.

Exclusion Criteria:

* Unable give informed consent.
* Unable to understand and follow instructions.
* Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.
* Known to have photosensitive epilepsy.
* Open head lesions or sores.
Combined Effects Of Sensory Integration And Vestibular Exercises On Post-Stroke Patients

The aim of this study is to determine the combined effects of sensory integration and vestibular exercise on dizziness, fall risk and quality of life.

This randomized controlled trial will be conducted at Mansoorah Teaching Hospital in 7 months after the approval of the synopsis. 38 participants with stroke will be included as per the sample size calculation through the convenience sampling technique. Participants who meet inclusion criteria will be randomly allocated using an online randomization tool into two groups Group A will receive Combine Sensory integration exercise and vestibular exercise with routine physical therapy for 40 minutes and Group B will receive Vestibular exercise with routine physical therapy for 40 minutes. Each group will receive a treatment session of 3 times in week for 6 weeks. The data will be analyzed using SPSS version 24.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Age between 40years-65years
* those who have been diagnosed with vestibular disorders
* An ability to stand for for 5 minutes without aid measured by 5 times sit to stand test.

Exclusion Criteria:

* Have bilateral or unstable vestibular loss
* Any neurological condition is present
* Active BPPV is present
* Any acute orthopaedic condition is present
* Peripheral neuropathy is present
* Visual impairment not corrected with glasses.
Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization

The objective of the study is to find out the in-hospital clinical outcomes among Chinese Acute Ischaemic Stroke (AIS) patients, who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset in different age groups (18 to 80 years and above 80 years).


Eligibility Criteria:
Inclusion Criteria:

* Patient registered in the Chinese Stroke Centre Alliance (CSCA) platform from Aug 2015 to Jul 2019
* ≥18 years old
* Diagnosed as Acute Ischemic Stroke (AIS) at admission
* Arrived or admitted into hospital within 4.5 hours of symptom onset
* For patients in the iv rt-PA groups only: received IV rt-PA within 4.5 hours of symptom onset

Exclusion Criteria:

* Documented Intravenous Thrombolysis (IVT) absolute contraindication
* Key data missing (age, gender, baseline National Institutes of Health Stroke Scale \[NIHSS\], time of symptom onset, IVT treated or not, time of IV alteplase treatment)
* Received thrombolysis agents other than IV rt-PA (urokinase, tenecteplase, recombinant plasminogen activator, prourokinase, streptokinase)
* Received endovascular treatment
* Received IV rt-PA after 4.5 hours of symptom onset
Microbial Diversity of Pancreatic Diseases

This study plans to analyze the digestive flora structure of the group of patients with pancreatic cancer.

The investigators compared the microflora of pancreatic cancer with other pancreatic diseases and healthy people，in order to obtatin the information of microbial community difference among the different groups. Finally，the investigators hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.

First, all the participants provided written informed consent for participating in the study. And the collecting procedures have no intervention or impact on treatment measures.

Second,the samples are collected, including the stools, the peripheral blood, and other digestive secretions. If the participants had surgical indications and received surgical treatment, the surgical resections of tissues (including paraffin section) are also collected.

Third, the participants were basically divided into three groups，cases with pancreatic cancer, cases with other pancreatic diseases, and health volunteers.

Finally, the investigators compare the microflora , its metabolites or effects among the different groups in their stool, digestive secretions, peripheral blood, pancreatic tissues ( (including paraffin section)) and so on, and hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 3 years old, ≤ 85 years old;
* After MDT discussion, routine surgery or ERCP can be performed, and the postoperative pathology is clear as pancreatic cancer and other pancreatic diseases;
* There is no serious damage to heart, liver and kidney function;

Exclusion Criteria:

* Women who are breast-feeding during pregnancy and after pregnancy;
* Patients with evidence of sensory or motor neuropathy;
* Those who have a clear cardiovascular disease, severe associated disease or active infection, including known HIV infection;
* Those who have a history of other cancers;
* Those who are allergic to drugs or their excipients
A Study to Compare the Effects of Sarpogrelate Sustained Release /Aspirin Combination Therapy Versus Aspirin on Blood Viscosity in the Patients With Peripheral Arterial Disease and Coronary Artery Disease

This study is to compare the effects of sarpogrelate sustained release /aspirin combination therapy versus aspirin on blood viscosity in the patients with peripheral arterial disease and coronary artery disease


Eligibility Criteria:
Inclusion Criteria:

1. Both man and woman who is over 19 years old
2. Identified as 10-75% of Stenosis in Coronary Angiography or Coronary CTA(Coronary computed tomography angiography)
3. Patients who diagnosed with peripheral artery disease or has symptoms
4. Written informed consent

Exclusion Criteria:

1. Patients who is scheduled surgery due to coronary artery disease or cerebral infarction disease.
2. Patients who have taken aspirin within two weeks before randomization
3. Patients who need antiplatelet or anticoagulant medication except Aspirin
4. Confirmed below results at screening

   * Hemoglobin \<13g/dL
   * Platelet \<60,000/µL
   * Severe kidney disease patient with eGFR(estimated Glomerular Filtration Rate) \<30 mL/min/1.73 m2 (CKD-EPI)
5. Patients with a history of cerebrovascular and cardiovascular complications (brain infarction, transient cerebral ischemic seizures, myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary artery intervention) within the last six months
6. Patients with bleeding
7. Pregnant or lactating women
8. Those participating in other clinical trials for investigational products
9. Patients deemed to be ineligible to participate in the trial by investigator
A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome

The purpose of this clinical research study is to learn if BMS-232632 administered as Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated vasodilatation (FMD), in HIV-infected patients. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

- Documented Metabolic Syndrome by at least 3 of the following parameters:

* Abdominal obesity, assessed by waist circumference (for men \>103 cm, for women \>88 cm).
* Triglycerides \> 150 mg/dl.
* HDL cholestrol (for men \<40 mg/dl, for women \<50 mg/dl).
* Blood pressure \> or equal to 130/85 mm Hg.
* Fasting serum glucose \> or equal to 110 mg/dl.
* HIV RNA \< 50 copies/mL.
* IP within 3 months prior to selection.

Exclusion Criteria:

-Treated Metabolic Syndrom
miRNA Biomarkers in Multiple Sclerosis

Multiple Sclerosis (MS) characterized by demyelination and axonal degeneration is a chronic inflammatory disease of the central nervous system (CNS). Recent studies have shown that dysregulated miRNAs alter immune responses, so they may have roles basis on various genetic diseases such as MS and may be potential targets for biomarkers and new therapeutic approaches. In this study, we evaluated the dysregulation of miRNA expression levels at MS and MS stages. We also discussed the potential of these miRNAs to be biomarkers and/or therapeutic targets in MS.


Eligibility Criteria:
Inclusion Criteria:

* The age of 25 years and above
* at least one Central Nervous System (CNS) demyelination event

Exclusion Criteria:

* with genetic diseases, hypertension, head trauma, neuropsychiatric disease, diabetes mellitus, hypertension, cardiac failure, hepatic failure, renal failure, Thalassemia, Sickle cell disease, iron deficiency, and B12 deficiency