cyrilzakka/clinical-trials huggingface dataset:
Using EMG of the Healthy Hand to Control TENS of the Affected Hand in Hemiparetic Patients

The purpose of this study is to investigate learning transfer from the healthy hand to the paretic hand in stroke patients. EMG signals from the healthy hand - while performing wrist dorsi flexion movement - will be used to activate electric muscles stimulation of the dorsi flexors of the paretic hand.

14 post-stroke subjects will be recruited from neurological rehabilitation department at Loewenstein rehabilitation hospital, Ra'anana, Israel. The patients will be randomly assigned to one of two groups: 1) Experimental group. 2) Control group. The 3 weeks intervention (15 sessions) in each group will include electric muscles stimuli (pulse rate 35-100Hz pulse width 200 microseconds, 5 sec on and 10 sec rest ) of the hemiparetic hand for 15 minutes. The patients in the experimental group will wear a wireless Bluetooth EMG ("Myo" bracelet) on their healthy forearm and when they will execute wrist dorsi flexion, the data will be transmitted to a PC which will be used to activate (via Arduino controller) a Transcutaneous Electric Nerve Stimulator (TENS) that is attached to the paretic dorsi flexors (electrodes are placed on the paretic forearm). The control group will get only automatic stimuli on the paretic forearm via the TENS.

The assessments will be done before the intervention, at the end of three weeks of intervention, and after 1 month from the end of the intervention (follow up).

The outcomes will include: active range of motion of fingers and wrist dorsi flexion (using cybermin 5DT glove for digital measures), upper limb section of Fugl-Meyer test, Box and Blocks test and Jebsen Taylor Hand Function Test. Only before the beginning of the intervention the sensory ability of the patient will be assessed using the Sensory section of Fugl-Meyer (FM) and Semmes-Weinstein filaments for superficial sensation. Normalized lesion data will be computed using the ABLE module within MEDx software (Medical Numerics).

Differences between groups will be calculated using t-tests or Mann-Whitney, depending on distribution of normality with corrections for multiple comparisons.

Eligibility Criteria:
Inclusion Criteria:

* First stroke
* Age 25-80 years
* Able to understand research instructions

Exclusion Criteria:

* Unstable clinical/metabolic state
Urinary Actin, as a Potential Marker of Sepsis-related Acute Kidney Injury

In our study, 17 septic, 43 sepsis-related acute kidney injury and 24 control patients were enrolled. Blood and urine samples were collected at the intensive care unit from acutely diagnosed septic and sepsis-related acute kidney injury patients at three time points (T1-3): T1: within 24 hours after admission; T2: second day morning; T3: third day morning of follow-up. Patients with malignancies needing palliative care, end-stage renal disease or kidney transplantation were excluded. Not more than one sample (venous blood, midstream spot urine) was collected from control patients. Serum and urinary actin levels were determined by quantitative Western blot. Urinary actin concentrations were expressed as µg/L, while serum actin levels were expressed as mg/L. Data were compared with laboratory and clinical parameters. Patients were categorized by the Sepsis-3 definitions and 30-day mortality data were investigated.

Actin is a globular protein present in every cell with a 42 kilodalton molecular mass. It plays an important role in muscle contraction while being an essential component of the cytoskeleton as well. Several proteins (e.g. gelsolin, Gc-globulin) bind actin in the circulation during the physiological cell turnover, thus making its urinary appearance unlikely. However, recent studies indicate that actin could be detected in the urine of kidney-transplant patients with acute kidney injury. Therefore, the main focus of our research was the detection and measurement of actin in the blood and urine in patients with sepsis or sepsis-related acute kidney injury, as the early recognition of kidney injury - especially in sepsis - is essential in the aspect of therapy and survival.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis
* Sepsis-related acute kidney injury

Exclusion Criteria:

* malignancies needing palliative care
* end-stage renal disease
* kidney transplantation
* under 18 years of age
* unobtainable consent
Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes (Vita-K 'n' Adults Study)

Given that glutamate carboxylation or decarboxylation is key to the metabolic role of osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and its subsequent effect on glucose metabolism in clinical trials. The purpose of this randomized, double-blind, placebo-controlled clinical trial in adults is to determine whether eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve markers in blood associated with diabetes risk.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults between 18 and 65 years old
2. Subject understands the study protocol and agrees to comply with it
3. Informed Consent Form signed by the subject

Exclusion Criteria:

1. Subjects using vitamin supplements containing vitamin k
2. Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
3. Subjects presenting chronic degenerative and/or inflammatory diseases
4. Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
5. Subjects receiving corticosteroid treatment
6. Subjects using oral anticoagulants
7. Subjects with a history of soy allergy
8. Subjects who have participated in a clinical study more recently than one month before the current study
Breathing Rescue for SUDEP Prevention

The purpose of this study is to precisely delineate human brain networks that modulate respiration and identify specific brain areas and stimulation techniques that can be used to prevent seizure-induced breathing failure.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of intractable focal epilepsy
* admitted to the Epilepsy Monitoring Unit (EMU) at Memorial Hermann-Texas Medical Center for intracranial subdural strips, grids, or depth electrode placement study (invasive video-EEG)

Exclusion Criteria:

* respiratory, cardiac or cerebrovascular disease
* pregnancy
* prisoners
Study Using Esomeprazole as a Diagnostic Test for GERD in Patients With NCCP

Gastroesophageal reflux disease (GERD), with its cardinal symptom, heartburn, is the most common disorder of the esophagus in the West. Comparatively, GERD is less common in Singapore but its frequency in the population is increasing. Although the vast majority of patients with GERD have heartburn and acid regurgitation, GERD can present in atypical ways, including as a non-cardiac chest pain (NCCP). We have previously shown that GERD is a common cause of NCCP in Singapore. Up to 40% of our patients with NCCP had endoscopic esophagitis, abnormal 24-hour pH monitoring results, and/or a positive acid perfusion test. These tests, although diagnostic, are costly, labour intensive, and not always readily available in the primary care setting. A trial of high-dose proton pump inhibitor (e.g. omeprazole 60 mg daily) has been proposed as a simple, safe, non-invasive and reliable means to diagnose GERD in Western patients with NCCP. We have not used the test routinely in our practice. This study will evaluate the use of a short course of esomeprazole, the S-isomer of omeprazole, as a diagnostic test for detecting GERD in patients with NCCP. The hypothesis is that in NCCP patients with GERD, esomeprazole will resolve their symptoms. Consecutive patients diagnosed with NCCP at the National University Hospital, Singapore, will be invited to participate in the study. Eligible patients will be randomly assigned to receive either esomeprazole (40 mg o d) for 14 days, or comparable dose of placebo at a similar schedule for 14 days, in a double-blinded fashion. At the start of the study, all subjects will complete a baseline symptom assessment. Symptoms will be scored on a graded scale based on severity. During the study weeks, each patient will record his/her own daily symptoms. The patient will be assessed again after the 14-day treatment. The primary outcome measure will be the change in symptom score after initiation of treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients with recurrent chest pain of more than three months duration with either (1) normal or non-obstructive coronary arteries (\<50% luminal diameter narrowing), (2) normal dobutamine stress echocardiography or (3) a negative exercise electrocardiogram and a cardiologist's evaluation that symptoms are not cardiac in origin.

Exclusion Criteria:

* Patients will be excluded if they are \< 18 or \> 70 years old, are pregnant, have a medical contraindication for esomeprazole therapy, have already been empirically treated with an antireflux regimen, report a history of peptic ulcer disease or gastrointestinal surgery, or are unwilling or unable to provide informed consent. In addition, patients who are unable to fully complete all stages of the study will be excluded.
Safety and Efficacy Study of TLL018 in the Treatment of Ulcerative Colitis

A study to investigate the safety and efficacy of TLL018 compared with placebo in subjects with moderate to severe ulcerative colitis.

This is a phase 2, multicenter, randomized, double-blind, parallel dose groups, placebo-controlled dose ranging study to evaluate the safety and efficacy of 3 doses of TLL018 as an induction therapy in subjects with moderate to severe UC.

Eligible subjects will be randomized to receive one of the following treatments: TLL018 low dose, TLL018 middle dose, TLL018 high dose, or placebo. All subjects may remain on a stable dose of conventional therapy used prior to enrollment. Subjects will be assessed for safety, tolerability, and response to treatment. Samples for pharmacokinetics (PK) and pharmacodynamics (PD) biomarker analyses will be collected throughout the study according to the Schedule of Assessments (SoA) for potential correlation to clinical outcomes.

Further participation may continue beyond the initial 8 weeks for another 5-week Extension Period of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥ 18 and ≤ 75 years of age at baseline.
* Capable of giving informed consent and complying with study procedures.
* Normal renal function or mild renal impairment as determined by the Investigator following review of clinical laboratory test results.
* Laboratory and medical history parameters within the protocol-defined ranges.
* Diagnosis of UC for 90 days or greater prior to baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia, and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
* Active UC with a full Mayo score of 6 to 12 points and endoscopic subscore of 2 or higher confirmed by central reader.
* Subject must have received COVID-19 vaccine \>2 months before first dose of study drug.

Exclusion Criteria:

* Pregnant or nursing women.
* Clinically significant history of cardiovascular, hematologic, renal, hepatic, bronchopulmonary, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator.
* Current and/or recent history of a clinically significant infection.
* Any history of malignancies, except for non-melanoma skin cancers (unless it is metastatic).
* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
* Any condition or finding that in the Investigator's opinion would put the subjects or study conduct at risk if the subjects were to participate in the study.
* Current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
* Current diagnosis of fulminant colitis and/or toxic megacolon, or active Clostridium difficile colitis.
* Subject with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
* Subject with previous exposure to JAK inhibitor (eg, tofacitinib, baricitinib, filgotinib, upadacitinib).
Neurovascular Product Surveillance Registry

Post market surveillance registry

An observational, prospective, multi-center, single-arm registry to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic Neurovascular market-released products used in the treatment of Intracranial aneurysms and Acute Ischemic Stroke.

MDT16056 and MDT17077 are conducted under the Product Surveillance Registry (NCT01524276).

Eligibility Criteria:
For MDT16056 and MDT17077

Inclusion Criteria:

* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
* Patient has, or is intended to receive or be treated with, an eligible Medtronic product
* Patient is consented within the enrollment window of the therapy received, as applicable
* Patient is at least 18 years of age at time of enrollment.

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.

For MDT24028 and MDT22032:

General Inclusion Criteria:

* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
* Patient is treated or intended to be treated with an eligible Medtronic Neurovascular product.
* Patient is an adult per local law at time of consent. Medtronic Business Restricted This document is electronically controlled CONFIDENTIAL 056-F275 Rev F Clinical Investigation Plan Template

General Exclusion Criteria:

* Patient who may be unable to complete the study follow-up
* Patient with any contraindications per the applicable Instructions for Use document
* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study
* Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.

Additional criteria may be required, refer to cohort-specific Addendum, as applicable, for further guidance.
Matrix Metalloproteinases (MMPs),Neutrophil Gelatinase-associated Lipocalin (NGAL) Tissue and Plasma Levels and Aneurysms

An association between arterial aneurysms and matrix metalloproteinases (MMPs) has been described previously. MMPs regulate extracellular structural proteins and tissue remodeling. Neutrophil Gelatinase-associated Lipocalin (NGAL) is involved in the regulation of MMP activity. The aim of this work was to study the relationship between the levels of MMPs and NGAL and arterial aneurysms.

In a multicenter, open label, parallel groups, prospective study, patients with aneurysmal disease were divided into two groups: Group I (with ruptured aneurysm) and Group II (with non-ruptured aneurysm). Healthy volunteer patients were also enrolled and represented the control group (Group III).

The investigators enrolled 307 patients (Group I: 107, Group II: 200) with arterial aneurysm: 49 popliteal, 31 common femoral, 2 superficial femoral, 29 common iliac artery, 3 common carotid and 193 abdominal aorta. Finally, 11 healthy volunteer patients (9 males and 2 females, age range 40-70 year-old, median 56) were enrolled in Group III.

Elisa test and Western blot analysis revealed greater levels of immunoreactive MMP-9 and NGAL in all patients with ruptured aneurysms, both central and peripheral aneurysms, and in the aneurismal vessels.

These results provide important advances in the understanding of the natural history of arterial aneurysms. MMPs and NGAL play a role in development of arterial aneurysms and they may represent molecular markers for the prevention of aneurysmal rupture

In the present study, the analysis of MMPs levels in plasma and tissues in patients with aneurysmal lesions identified several patterns of protease activity. Levels of both MMP-9 and NGAL were increased in aneurismal vessels, while the patterns of MMP-9 and NGAL expression was very high in all patients with ruptured aneurysm, both central and peripheral. These results show: 1) the chronic and degenerative nature of the aneurysmal lesion which is associated with increased levels of inflammatory proteinases, like MMP-9; 2) the apparent pivotal role of MMP-9 and NGAL in the pathophysiologic processes which lead to the final stage of natural history of aneurysms; and 3) the ubiquitous distribution of MMP-9 and NGAL. The pattern increased expression of MMP-9 and NGAL appears to be specific for aneurysmal arteries and it is not dependent on the anatomic site of the lesion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of arterial aneurysmal disease

Exclusion Criteria:

* History of cancer
* Hepatic failure
* Infectious or autoimmune diseases
* Patients requiring endovascular treatment.
Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma

The goal of this clinical trial is to learn about radiofrequency ablation in patients with unresectable bile duct cancer who receive systemic chemotherapy and bile duct stenting. The main questions it aims to answer are:

* Does radiofrequency ablation of tumorous bile duct occlusion reduce risk of complications in these patients (eg stent dysfunction, delay of chemotherapy, infections etc)?
* Is radiofrequency ablation safe in these patients? All participants will receive standard treatment with systemic chemotherapy and bile duct stenting. Researchers will compare two groups (one group will receive additional radiofrequency ablation, the other not).


Eligibility Criteria:
Inclusion Criteria:

1. Unresectable perihilar and/or ductal CCA with bile duct stenting and palliative systemic therapy as indicated by the local Multidisciplinary Team (MDT)
2. Written informed consent
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
4. Age ≥18 years
5. Eligibility for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT
6. No prior radiofrequency ablation (RFA) for CCA
7. No repeated bile duct stenting in the past 3 months (trial inclusion is possible upon first stent replacement or initial stent placement within past 3 months)
8. No concomitant disease or malignancy interfering with the study procedure or efficacy outcome measures, particularly no severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction within ≤3 months, significant arrhythmias) and no psychiatric disorders precluding understanding of information of trial related topics and giving informed consent
Assessment of Ocrelizumab (OCR) Treatment Effects on Functional Impairment of MS Patients Enrolled in the Phase III Orchestra Programme Using Multimodal Evoked Potentials (EP) and Highresolution Electroencephalography (EEG)

Multiple Sclerosis (MS) is not only an 'inflammatory' demyelinating disease, but also includes axonal and neuronal injury in the grey matter . Neurodegenerative processes are partly independent of lesion formation and relapse activity , but represent the direct driver of clinical long-term disability and cognitive decline.

Multimodal evoked potentials (EP), i.e. the combination of visual, somato-sensory and motor EP (VEP, SSEP, MEP) have been shown prospectively to provide objective, monovectorial, and numerical data which are closely correlated to the EDSS. As EP capture the functional integrity of the examined systems they represent a method unbiased for directional changes, while remaining specific for the neuronal function, and hence can measure deterioration, as well as improvement, a germane advantage to capture drug response.

High-resolution electroencephalography (EEG) allow for explorative analysis of potential surrogate markers for cognitive decline.

Ocrelizumab (OCR), a humanized anti-CD20 monoclonal antibody has shown strong treatment effects on number of T1Gd-enhancing lesions , on new T1Gd-enhancing and new T2-hyperintense lesions as well as on the annualized relapse rate in a recent phase II trial in relapsing-remitting MS.

The present study will investigate the effects of OCR on multimodal evoked potentials (EP), Furthermore, quantitative EEG as a potential correlate of cognitive dysfunction and fatigue will be explored.


Eligibility Criteria:
Inclusion Criteria:

* definitive inclusion in one of the phase III trials on OCR: relapsing remitting multiple sclerosis (RRMS) patients in "Opera I" (WA21092B) or "Opera II" (WA21093), primary progressive multiple sclerosis (PPMS) patients in "Oratorio" (WA25046B) and fulfilling the respective inclusion criteria
* stable clinical state (at least 4 weeks after treatment with corticoids, when there was a relapse)
* Provision of written informed consent and ability to be compliant with the schedule of assessments of the present study

Exclusion Criteria:

* exclusion criteria of both phase III trials on OCR also apply to the present study
* additionally patients with movable metal implants, e.g. pace-maker, stents, deep brain stimulators are excluded; (patients with jaw- or bone-fixed metal implants can be included)
Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

The aim of the present study is to develop and validate the effects of a new cognitive behavioral therapy (CBT) using digital healthcare mobile apps such as Noom Coach and InBody.

Seventy female participants whose BMI scores were above 23 and who had no other clinical problem except obesity were randomized into an experimental and a control group. Forty-five people in the experimental group were connected with the therapist using digital healthcare apps, so they got daily feedbacks and assignments for 8 weeks. Twenty-five people in the control group also used digital healthcare apps but they were asked to do self-care without intervention.

Eligibility Criteria:
Inclusion Criteria:

* SIMS score ranks over high 20% of total

Exclusion Criteria:

* Had been prescribed with psychological problems or medical problems.