cyrilzakka/clinical-trials huggingface dataset:
MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience

This US multicenter, prospective cohort study aims to evaluate how MSCopilot can be seamlessly integrated into the current care pathway and identify potential optimizations to enhance its impact on both MS patients and clinicians, facilitating broader implementation. Specifically, the study will assess:

* The overall integration of MSCopilot into routine clinical practice,
* Patients' ability to use MSCopilot at home without supervision,
* The need for patient support when using MSCopilot at home,
* User behavior based on usage analytics data from the MSCopilot mobile app and dashboard,
* Patient adherence to MSCopilot use in routine clinical practice,
* The adequacy of the onboarding/training process for HCPs,
* The effectiveness of HCPs onboarding/training in ensuring successful patient onboarding,
* The variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores


Eligibility Criteria:
Inclusion Criteria:

For patients

* 18 years and older
* With a confirmed and documented MS diagnosis, per the 2010 Revised
* McDonald criteria
* With an EDSS score ranging from 0 to 6.5
* Able to monitor their disease from home (i.e. not hospitalized or under medical assistance).
* Having a personal smartphone with a mobile operating system above 16 for IOS (iPhone) and 8 for Android and having access to a good internet connection.
* Able to read language in which the mobile application is available and able to understand pictograms Having read the information sheet and signed the informed consent form

For HCPs:

* Licensed neurologists trained in the management of Multiple Sclerosis patients and allowed to conduct clinical studies within their departments
* If applicable: nurses or medical assistants specifically trained in the management of Multiple Sclerosis and allowed to participate in clinical studies within their departments
* Ability to use a computer

Exclusion Criteria (for patients):

* Pregnant and nursing women
* Person under guardianship or curatorship
* Inability to use a smartphone application
* Patient who previously participated in a study using MSCopilot

Early termination criteria (for patients):

* exclusion criteria,
* death,
* abandon,
* loss of follow-up,
* investigator's decision
Valvular Aortic Stenosis Prognosis Study

Aortic stenosis is the most common valvulopathy in Western countries. Cardiac EchoDoppler is the reference method for assessment of aortic stenosis and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low flow and low gradient aortic retraction is discussed.

The main objective of this work is to study the prognosis of asymptomatic and symptomatic aortic retraction.

Aortic stenosis is an attack most often acquired from the aortic valve corresponding to a defect of opening of this valve. Its prevalence increases with age and approaches 2% at age 65 and 25% at age 85 . It is in the majority of cases degenerative due to the development of calcifications on the aortic sigmoid valves by a process close to atherosclerosis (Otto CM, Circulation, 1994). It is associated with cardiovascular risk factors (age, male sex, smoking, high blood pressure and associated high LDL cholesterol). Aortic stenosis may also frequently be the consequence of aortic bicuspid (congenital) or more rarely rheumatic fever.

Aortic stenosis is responsible for an obstacle to ejection of the left ventricle with increased afterload and thus left ventricular work. After a long asymptomatic period when the obstacle to ejection is compensated by the induction of an adaptive left ventricular hypertrophy, symptoms appear initially of effort (dyspnea, angina, lipothymia see syncope) then clinical signs of insufficiency heart. The occurrence of symptoms should cause aortic valve replacement because at this stage the prognosis becomes unfavorable with a risk of death by cardiac decompensation or sudden death.

The two pillars of the diagnosis of severity are the evaluation of functional aortic valve area and the average transvalvular gradient. The tight aortic stenosis is defined for a functional aortic area \<1cm² or 0.6cm² / m² and a mean tranvular gradient\> 40 mmHg.

Patient survival data and / or a possible complication or indication for surgery will be evaluated periodically either during a standard follow-up consultation if patients are followed in the referral center or by telephone contact with the attending physician or cardiologist. . In case of death, the cause and date will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Retrospectively, all patients examined from January 1, 2000 to November 2014 will be included in the echocardiography laboratory whose objective examination is a narrowing of the aortic valve (maximum transaortic velocity ≥2.5 m / s).
* Aortic stenosis may be known in the past.

Exclusion Criteria:

* Refusal of the patient to participate in the study.
* Patients who have previously had aortic valve surgery before being examined in the echocardiography laboratory.
* Patients who can not be contacted or who do not respond will not be included in the database.
The Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane Block to Reduce the Narcotic Dosage and Pain After Cesarean Delivery

Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery.


Eligibility Criteria:
Inclusion Criteria:

* female 18 to 40 Years
* class ASA 1 and 2
* candidates for elective cesarean section

Exclusion Criteria:

* renal failure
* liver failure
* cardiac disorder
* coagulopathy
* hepatomegaly
* splenomegaly
* drug sensitivity and abuse
* morbid obesity
* smoking
* history of post operative nausea and vomiting
* motion sickness
* local hypoesthesia
A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain

The purpose of this study is to evaluate efficacy and safety of fentanyl in opioid-naive participants with osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) or low back pain who cannot obtain a sufficient analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).

This is a multi-center (conducted in more than one center), double-blind (neither the participant nor the physician knows the assigned study drug), randomized (participants assigned study drug by chance), withdrawal study in opioid-naive participants with osteoarthritis or low back pain. The study will consist of titration period (10-29 days) and double-blind period (12 weeks) and the visits will include Day 5-7, 8, 15, 29 in titration period and Day 2-4, 8, 15, 22, 29, 43, 57, 71 and 85 in double-blind period. All the eligible participants will receive one-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) of either fentanyl at the dose ranging from 12.5 to 50 microgram per hour (mcg/hr) or matching placebo. Efficacy will be evaluated primarily by time to withdrawal due to insufficient analgesic efficacy. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants whose pain because of osteoarthritis or low back pain is continuing for at least 12 weeks prior to informed consent
* Participants who are continuously taking a non-opioid analgesic at the normal highest dose or more for at least 14 consecutive days prior to informed consent, or participant at a certain dose (except the use on an as-needed base) on consecutive days
* Participants showing insufficient therapeutic efficacy of the non-opioid analgesic currently being used, and requiring a continuous opioid analgesic as per the investigator or sub-investigator
* Participants with an average pain intensity of 50 millimeter or more on the Visual Analog Scale (VAS) in 24-hour daily living prior to informed consent
* Participants who can be hospitalized to the 4th day after the initiation of titration period

Exclusion Criteria:

* In cases of low back pain, participants with severe pain of lower extremities due to radiculopathy (a problem in which one or more nerves are affected) than that of low back pain, or participants with disc herniation (a medical condition affecting the spine due to trauma, lifting injuries, or idiopathic \[unknown\] causes) requiring an operation
* In cases of low back pain, participants with pain due to compression fracture
* Participants who had an operation that may affect the assessment within 30 days before informed consent
* Participants whose main cause of the pain to be assessed is considered attributable to psychogenic pain (physical pain that is caused, increased, or prolonged by mental, emotional, or behavioral factors)
* Participants with asthma, bradyarrhythmia (slow irregular heart beat) and severe respiratory function disorders
DNA Methylation Biomarkers and Metastasis of Gastric Carcinoma

Gastric carcinoma (GC) is the second leading cause of cancer death throughout the world. In previous multi-center study, we have found that the prevalence of GDNF family receptor alpha 1(GFRA1), serum response factor (SRF), and ZNF382 methylation alterations were inversely and coordinately associated with GC metastasis and the patients' overall survival throughout discovery and testing cohorts in China, Japan and Korea. The present cohort study is to investigate whether methylation of those genes can predict the metastasis and prognosis of GC.

Background: Metastasis is the leading cause of death for gastric carcinoma (GC). Currently, GC prognosis is primarily determined based on the clinical data and pathological stages of patients at the time of diagnosis and treatment. However, successful management of GC patients is still hampered by lack of highly sensitive and specific biomarkers capable of predicting prognosis and likelihood of metastasis. GFRA1 hypomethylation along with SRF and ZNF382 hypermethylation were found to be potential synergistic biomarkers for the prediction of GC metastasis in our previous multi-center study. In addition, p16 and E-cadherin were also correlated with GC metastasis in Chinese cohort. To investigate the predictive value of those genes' methylation on metastasis potential in GC, we carried out the prospective cohort study.

Methods: 198 early stage GC patients without lymph node or distal metastasis were included in the present study. Baseline information of E-cadherin, GFRA1, p16, SRF and ZNF382 methylation status of the GC from 191 cases was obtained by MethyLight. The follow-up examination was carried out in a double-blind study with a 6-month interval. The association between gene methylation and metastasis of GC was analyzed with SPSS16.0 software. All P-values were two-sided.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of gastric adenocarcinoma;
* Early stage GC without lymph node and distal metastasis;
* Availability of frozen, fresh GC and corresponding surgical margin samples;
* Available of methylation status of gene CpG island in the extracted DNA sample.

Exclusion Criteria:

* GC with lymph node or distal metastasis;
* Quality of the prepared DNA is not good enough for detection of gene methylation;
* GC cases were subjected to the neoadjuvant chemotherapy.
Effects Of Transcutaneous Vagus Nerve Stimulation With Virtual Reality In Post-Stroke Patients

Stroke is a neurological condition also known as cerebrovascular accident occurs when blood supply to the brain is disrupted ,either by blockage or rupture of a blood vessels. Upper limb impairment after a stroke denotes diminished function in the arm, hand, wrist, and fingers due to neurological damage. Virtual Reality and Trascutaneous vagus nerve stimulation are innovative for post-stroke upper limb rehabilitation VR enhances motor learning and engagement with exercises and feedback, while VNS boosts neuroplasticity and reduces inflammation via vagus nerve stimulation. The aim of the study is to determine the effects of transcutaneous vagus nerve stimulation with virtual reality and routine physiotherapy on upper limb motor function, hand dexterity function and quailty of life .

This randomized clinical trial will be conducted at Al Ehsan Welfare,Lahore .The sample size calculated for this trial will be 50 .The patients will be randomly allocated using online randomization tool into 2 groups. Group A will receive Transcutaneous vagus nerve stimulation with Virtual Reality and Routine physical therapy.Patients will undergo a 60-minute session for four weeks, consisting of 30 minutes of vagus nerve stimulation, 15 minutes of virtual reality training, and 15 minutes of routine physiotherapy for 4 weeks, Group B will receive Transcutaneous Vagus Nerve Stimulation with Routine physical therapy Patients will undergo a 60-minute session for four weeks, which includes 30 minutes of vagus nerve stimulation and 30 minutes of routine physiotherapy per session for 4 weeks.

Purdue pegboard test will be used to assess dexterity function,Fugl - meyer assesment FMA - UE to assess Motor function of upper extremity, Stroke impact scale to measure Quality of life.The assessment will be conducted by assessor at baseline, 2 weeks, 4 weeks, and during a follow-up at 8 weeks after discontinuation of in-clinic therapy.The p value will be set at P= 0.05 to reported any significant difference.Kolmogorov-smirnov test will be used to check the normality of data . For the between group analysis Independent t test will be applied for parametric and Mann Whitney test will be applied for non parametric data. For within group comparison repeated measure ANOVA and Friedman ANOVA will be applied for parametric and non parametric data


Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic stroke at least more than 6 months.
* Patients having Montreal Cognitive Assessment (MoCA) score 26/30
* Patients able to follow and accept verbal instruction
* patients with normal sympathetic acitivity.

Exclusion criteria:

* Patients with history of previous surgical intervention on vagus nerve
* Patients having low heart rate 60 bpm
* Patients with history of any visual and hearing problem
* Patients with history of neuromuscular disorder affecting the function of upper limbs .
* Patients with advance liver,kidney,cardiac ,pulmonary disease
* Patients with history of orthopedic surgery and botulinum toxin injection.
* Patients with increase sympathetic activity.
A Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy

In china, there are the most population of type 2 diabetes mellitus (DM) among the world and DM becomes currently the second cause for end-stage renal disease (ESRD). Nearly 50% of insulin-treated PD patients in clinical practice are treated with premixed insulin. Glycemic control in them is very difficult to be achieved mainly due to the uremic status of these patients and glucose exposure from peritoneal dialysate, a higher glycemic variability and higher risk of hypoglycemia. Linagliptin, unlike other DPP-4 inhibitors, has a primarily non-renal elimination route, and does not require dose adjustment for any level of impaired renal function. The aim of this study is to evaluate the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are inadequately controlled with premixed insulin therapy.

This will be a randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are inadequately controlled with premixed insulin therapy.which will be conducted in 8 diabetes centres and/or nephropathy departments in China. After a 4-week run- in period, 232 participants are randomized (1:1) to either premixed insulin combined with linagliptin (5mg/d) group (also named combined group) or premixed insulin alone group (also named insulin group) for 12 weeks. Finally, the primary endpoint is glucose variability indicated by MAGE, secondary endpoints include HbA1c, FPG, PPG, LAGE, SDBG, PT10.0, PT3.9, 1h fasting MBG, 3h postprandial MBG, insulin dosage, hypoglycemia and body weight.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetic patients who were treated with insulin regimen;
2. Ages eligible for study:18 years to 80 years;
3. The patients with end-stage kidney disease receiving a regular peritoneal dialysis for at least 3 months;
4. HbA1c ranging from 6.5%-10.5% when screening and randomizing ;
5. Body mass index ranging from 21 to 35 kg/m2.

Exclusion Criteria:

1. Having any severe acute or chronic diabetic complications
2. Blood aminotransferase level rising up more than 2 times of the upper normal limit
3. Any severe cardiac disease, severe systemic diseases or malignant tumour
4. Female patients incline to be pregnant
5. Being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
6. Poor compliance
Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 With Inflammatory Markers

The trial evaluates the efficacy and safety of Tocilizumab, which rapidly reduces the inflammation process through inhibition of IL-6 in patients with moderate to severe COVID-19 with increased inflammatory markers. There will be two arms in the trial, one receiving the best supportive care, and the other receiving it plus tocilizumab. Patients will be followed until Day 29 after randomization.

Coalition VI (TOCIBRÁS) is a prospective phase III randomized controlled trial that evaluates the efficacy and safety of Tocilizumab, an antibody anti-IL-6 receptor in patients with moderate to severe COVID-19 with increased inflammatory markers. This is a superiority open-label study with two arms. The control arm receives the best supportive care, and the experimental receives it plus tocilizumab. Randomization is done centrally by REDCap 1:1. Patients will be followed until Day 29 after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Male and females with 18 years and older
* Confirmed diagnosis of SARS-CoV 2 infection
* More than 3 days of symptoms related to COVID-19
* Computed tomography (or Chest X-Ray) with COVID-19 alterations
* Both of the criteria

  1. Need for oxygen supplementation to keep SPO2 \> 93% OR need for mechanical ventilation for less than 24 hours before the randomization
  2. At least two of the following inflammatory tests above the cutoff :

     1. D-dimer \> 1,000 ng/mL
     2. Reactive C protein \> 5 mg/dL
     3. Ferritin \> 300 mg/dL
     4. Lactate dehydrogenase \> upper level limit

Exclusion Criteria:

* Need for mechanical ventilation for 24 hours or more before the randomization
* Hypersensitivity to tocilizumab
* Patients without therapeutic perspective or in palliative care
* Active non controlled infections
* Other clinical conditions that contraindicate tocilizumab, according to the assistant physician
* Low neutrophils count (\< 0.5 x 109/L)
* Low platelets count (\< 50 x 109/L)
* Liver disease, cirrhosis or elevated AST or ALT above 5 times the upper level limit
* Renal disease with estimate glomerular filtration below 30 mL/min/1.72 m2 (MDRD or CKD-EPI scores)
* Active diverticulitis
* Breastfeeding women
* Pregnancy
Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.


Eligibility Criteria:
Inclusion Criteria:

1. Understand the specific process of the test, voluntarily participate in the test, and sign the informed consent form in writing（In healthy people and chronic hepatitis B）.
2. Age 18-55 (including boundary value) （In healthy people）; Age 18-65 (including boundary value) （In chronic hepatitis B）.
3. Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) 18\~28 kg/m2 (including boundary value) （In healthy people）.
4. Normal or abnormal vital signs, physical examination, laboratory examination, chest radiograph, etc. have no clinical significance（In healthy people）.
5. Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months after screening and the last study drug administration（In healthy people）.

Exclusion Criteria:

1. Those suffering from any clinical serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality, or any other disease that can interfere with the test results（In healthy people）.
2. Previous history of malignant tumor（In healthy people）.
3. Those who have digestive system disease or serious digestive system disease at present or in the near future (within one month), and the researcher believes that it may affect drug absorption or have safety risk（In healthy people）.
4. Those who have serious infection, serious injury or major surgery within 3 months before administration; Those who plan to undergo surgery during the trial and within two weeks after the end of the trial（In healthy people）.
5. Serious cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled conditions, including but not limited to myocardial infarction, unstable angina pectoris, heart failure, and moderate stroke（（In chronic hepatitis B））.
6. Clinically significant liver diseases caused by other causes (such as alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced liver injury, alcoholic hepatitis, etc.); （In chronic hepatitis B）.
The Imaging Genetic Study of the Core Family of Obsessive-compulsive Disorder (OCD) Patient

To investigate the structural/functional abnormalities and the possible genetic endophenotypes of Obsessive-compulsive disorder (OCD) patients and their core families.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed OCD patient

Exclusion Criteria:

* organic disease
* other psychiatric disorder