cyrilzakka/clinical-trials huggingface dataset:
Visual (Path)Ways in Multiple Sclerosis - Part II

Multiple sclerosis (MS) is an inflammatory demyelinating and degenerative disease of the central nervous system. The mechanisms of neuro-axonal loss remain incompletely elucidated. An acute demyelinating lesion will produce both immediate and delayed axonal loss. Immediate axonal loss is linked to the occurrence of axonal transection. Delayed axonal loss is the cause of axonal degeneration in progressive MS. Visual impairment is common in the disease (vision, oculomotricity, cognition). Through a longitudinal multimodal analysis of visual pathways, we would like to investigate physiopathological mechanisms leading to neurodegenerative process and visual impairment.


Eligibility Criteria:
Patients with relapsing-remitting multiple sclerosis receiving high-efficacy or non-high-efficacy treatment and follow-up at the CRCSEP of the Lille University Hospital through past participation in the VWIMS study.

Inclusion criteria:

* Male and/or female participants in the VWIMS research project
* At least 18 years of age at the time of inclusion in VWIMS - II
* Patient having given written consent to participate in the study
* Socially insured patient
* Patient willing to comply with all study procedures and duration

Exclusion Criteria:

* Age \< 18 years
* Other neurological pathologies that may interfere with MRI and/or OCT data (diabetes, retinopathy \[any cause\], glaucoma, retinal detachment, ametropia \> 6 diopters)
* Contraindications to MRI (claustrophobia, incompatible metal foreign bodies such as certain pacemakers and mechanical valves, cochlear implants, intra-orbital metal splinters, pregnancy, certain brands of IUD because of the 3 Tesla magnetic field).
* Contraindication to injection: severe renal failure with creatine clearance \<30, allergy to contrast media, pregnancy, breast-feeding.
* Pregnant women
* Nursing women
* Persons incapable of giving consent on their own, with or without legal protection (guardianship/curatorship)
* Person under legal protection
* Persons deprived of their liberty
* Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent form
Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study)

This study will recruit 50 healthy women with normal menstrual cycles aged 40-50, to investigate the expression of their NEI network and urine metabolomics.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy women with normal menstrual cycles aged 40-50.
2. The score of Kupperman index is less than 15.
3. Not alcoholics or smokers (past or smoking).
4. Get subjects informed consent process should comply with GCP requirements.

Exclusion Criteria:

1. Volunteers with heart, liver, kidney disease or acute or chronic gastrointestinal diseases, or with diseases of blood, endocrine, neurological and other systems.
2. Volunteers are participating in other clinical trials within 3 months.
3. Volunteers who donated blood or loosed blood heavily within 3 months.
4. Volunteers with previous history of mental illness, drug abuse or drug dependence.
5. Volunteers who took drugs within 14 days before the trail.
Effect of Shoulder Symptom Modification Procedure (SSMP) in Managing Patients with Frozen Shoulder

the study is about intervention to patient with frozen shoulder to help patients improve function and shoulder disability , reduce pain and improve range of motion, the main aim of this study is to find out which treatment intervention SSMP , MWM and sham mobilization give effective results


Eligibility Criteria:
Inclusion Criteria:

* • Diagnosis of adhesive capsulitis confirmed by a healthcare professional.

  * Scores more than 2 in adhesive capsulitis scale
  * Range of motion affected in capsular pattern
  * Age between 40-65 years.
  * Willingness to participate by signing informed consent

Exclusion Criteria:

* Having any history of shoulder dislocation
* Humerus fractures or trauma
* Diagnosed with any sort of cancer
* History of cardiovascular disease
Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia

The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have completed Study SPD422 308
Examining the Effectiveness of the myPlan App to Prevent Dating Violence With Adolescents

Intimate partner violence (IPV), including violence in teen dating relationships \[teen dating violence (TDV)\], is a common and a serious threat to adolescent health, safety, and well-being. TDV may include psychological/emotional abuse, sexual harassment or coercion, stalking (including cyberstalking), and physical or sexual violence. For many, the first experience of violence is in a dating or casual relationship with a partner or acquaintance during adolescence. Therefore, the objective of this study is to examine the effectiveness of an adapted version of the myPlan app for adolescents (ages 15-17 years) to prevent and respond to TDV. myPlan is an app available for mobile download or by web browser that interactively assists users to assess the health and safety of user's intimate relationship, receive personalized strategies on how build healthier relationships, stay safe and healthy while navigating an unsafe relationship, and get connected to support and resources.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 15-17 years old
* Lives in the United States
* Reports current or past 6 months physical violence, sexual violence, emotional abuse, verbal abuse, or staking (including cyberstalking or electronic aggression) by a dating/casual/intimate/ex-intimate partner
* Speaks/reads English
* Has access to a safe device (e.g., smartphone, tablet, or computer) with internet access and comfortable downloading an app or using the internet
* Has a safe contact phone number or email address

Exclusion Criteria:

* Younger than 15 years of age
* Older than 17 years of age
* Does not report current or past 6 months abuse from a dating/casual/intimate/ex- intimate partner
* Does not speak/read English
* Does not have access to a safe device (e.g., smartphone, tablet, or computer) with internet access
* Does not have a safe contact phone number or email address
Efficacy and Safety of Metoprolol Succinate Prolonged-Release Tablet in Patients With Mild to Moderate Hypertension

This is an open-label, non-comparative, multi-centre clinical study to evaluate the Efficacy and safety of Metoprolol Succinate prolonged-release tablet (Betaloc Zok) in patients with mild to moderate essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Newly diagnosed essential hypertension who have not received anti- hypertensive treatment, or patients without antihypertensive medication in two weeks before screening, 90mmHg\<SiDBP \<110mmHg and SiSBP \<180mmHg.

Exclusion Criteria:

* Known or suspected secondary hypertension
* Resting HR is \< 55bpm.
* Sick sinus syndrome
* Atrioventricular block of first degree (with P-R\>0.24seconds), or second or third degree
The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study

Prospective, controlled, double randomized, non-blinded, multicenter, investigator initiated, academic superiority trial comparing optical coherence tomography (OCT) guided vs. angiography guided wire recrossing in jailed side branches (SB) (1. randomization 1:1)(superiority) and comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium (2. randomization 1:1) (superiority). Acute primary endpoint and 30 days clinical follow-up.

Hypothesis: OCT guided wire recrossing in bifurcation stenting results in less malapposed struts in the segment facing the SB ostium.

Secondary hypothesis: Treatment by Medtronic Resolute Integrity stent results in less malapposed struts at the bifurcation segment compared to treatment by the Abbott Xience Prime stent.

Purpose:

To assess the ability of OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.

To compare stent strut apposition after treatment by two different stent designs using both guiding strategies of wire recrossing.

Eligibility Criteria:
Inclusion Criteria:

* Stable or unstable angina pectoris or silent angina pectoris.
* De novo coronary bifurcation lesions at "LAD/diagonal", "Cx/obtuse marginal", "right coronary artery (RCA)- posterior descending artery (PDA)/posterolateral branch" or "left main (LM)/Cx/LAD".
* All Medina classes except Medina 0.0.1.
* Diameter of side branch ≥2.5 mm.
* Diameter stenosis \>50% by operator's visual assessment
* Signed informed consent

Exclusion Criteria:

* ST-elevation infarction within 48 hours.
* Side branch lesion length \>5 mm.
* Expected survival \< 1 year
* Severe heart failure (NYHA≥III)
* S-creatinine \>120 µmol/l.
* Allergy to Contrast media, Aspirin, Clopidogrel, Ticagrelor, Ticlopidine, Everolimus or Zotarolimus.
Central Compartment Neck Dissection With Thyroidectomy

When a patient presents with a thyroid mass, part of the work-up may include a fine needle aspiration biopsy (FNAB). The results of the biopsy then help plan treatment. If the results are benign, the management will typically be to follow the nodule. If the results demonstrate or are suspicious for cancer, such as papillary thyroid carcinoma (PTC), the treatment is a total thyroidectomy (total thyroid removal). The latest American thyroid association guidelines for PTC (2009) suggest that in many instances a central lymph node dissection (CLND) should be performed in conjunction with the total thyroidectomy. This procedure consists of removing the lymphatic (glandular) tissues surrounding the thyroid itself, as this tissue may have a propensity for cancer spread. The procedure's necessity has met much controversy in the last decade, but is becoming more of a standard in thyroid cancer surgery.

When a thyroid nodule FNAB is reported as indeterminate, the treatment strategy is less clear cut. While a diagnostic hemi-thyroidectomy or therapeutic total thyroidectomy may be in order, the inclusion of CLND is not clearly defined. In many centers a CLND will be omitted with surgical management for an "indeterminate" lesion, while in others, it is standard protocol. The argument of performing CLND is largely based on the tenet that it adds little surgical time, cost or risks to the patient. Because the evidence of the prognostic role of lymph node metastases is limited many would argue that the risk of not performing CLND is greater than performing CLND. Furthermore, in the event of finding cancer on final pathology, and thus, having to re-operate in the thyroid/central compartment bed, post-operative complications may increase. Opponents of CLND argue that there is a paucity of strong evidence supporting CLND in the improvement of oncologic outcomes and can potentially increase post-operative low calcium levels or vocal nerve damage However, these recommendations are based on retrospective level III evidence. Thus the debate continues: is CLND justified as an adjunct to hemi-or total thyroidectomy in indeterminate thyroid pathology?

The hypothesis is: CLND in hem- or total thyroidectomy for "indeterminate" thyroid nodules will not increase post-operative complications.


Eligibility Criteria:
Inclusion Criteria:

* Indeterminate or benign pathology on fine needle aspirate biopsy
* Scheduled to undergo total or hemi-thyroidectomy
* \> 18 years old

Exclusion Criteria:

* Previous thyroid surgery
* Previous neck surgery in field of thyroidectomy
* Previous neck irradiation
* Pre-operative hypocalcemia or hypoparathyroidism
* Biopsy suggestive of thyroid cancer
* Neck nodes suspicious for or with known cancer
* Pre-operative vocal cord dysfunction
Explainable Ocular Fundus Diseases Report Generation System

To establish a deep learning system of various ocular fundus disease analytics based on the results of multimodal examination images. The system can analyze multimodal ocular fundus images, make diagnoses and generate corresponding reports.

The ocular fundus is the only part of the human body that can directly see the blood vessel microcirculation and nerve tissue. Through various imaging tests, including Color Fundus Photograph (CFP), Optical Coherence Tomography (OCT), Fluorescein Fundus Angiography (FFA) and Indocyanine Green Angiography (ICGA), etc., it is possible to statically overview or dynamically observe the retina and choroid, the condition of blood vessels and nerves, and comprehensive diagnosis of the disease. The screening, interpreting and accurate diagnosis of ocular fundus diseases are crucial for disease prevention, control and precise treatment. However, due to the variety of fundus examination methods, and the complexity and professionalism of the examination, there is a lack of fundus specialists who have sufficient clinical experience and knowledge to interpret fundus examinations. With the continuous development of artificial intelligence (AI) in diagnosing fundus diseases, various modalities of imaging examination methods are gradually applied to the development of fundus disease diagnosis systems. Moreover, medical images often come with corresponding reports, which are mostly generated by clinicians' or radiologists' experience.

Here, we are establishing a fundus disease diagnosis and report-generating system based on cross-modal ocular fundus imaging examinations, and fundus lesions were visualized at the same time. Multi-center data verification will also be conducted. The results of the research will assist in fundus lesions diagnosis and imaging reports generation. We hope this could popularize more complex fundus imaging examination methods to society, and help improve the early diagnosis and treatment of fundus lesions that cause blindness.

Eligibility Criteria:
Inclusion Criteria:

* The quality of multimodal ocular fundus disease examination images and corresponding reports should be clinically acceptable.

Exclusion Criteria:

* Reports with key information missing.
* Images with severe image resolution reductions, blur or artifacts were excluded from further analysis.
Optimal Dose of i.v Oxycodone for Postoperative Pain

Postoperative pain control is required after major abdominal surgery, including laparoscopic colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control mainly in Europe.

The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean.

Oxycodone is known to be effective in pain control and has less sedative effect than morphine does. It has been described that distribution of cytochrome P450, which is associated with metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone after major abdominal surgery has not been well defined in Korean. The purpose of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean based on pain score and side effects.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class 1, 2
* Expected surgical time between 2\~ 6hours
* Scheduled for laparoscopic colorectal surgery

Exclusion Criteria:

* Severe dysfunction of liver, heart, kidney, or lung
* Cannot understand numeric rating scale of pain
* Known or suspected allergy to oxycodone
* Previous history of postoperative nausea or vomiting
* Medication of antidepressants
* Postoperative longterm
* ICU care or prolonged mechanical ventilatory support
* Chronic pain
* Drug abuser
* Hypersensitivity reaction to aspirin or NSAIDs
* Refuse to enroll
Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)

Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical practice, following commercial release of iATP-capable devices.

The iATP PAS is conducted within Medtronic's Product Surveillance Registry platform (NCT01524276).

The iATP PAS is a global, prospective, observational, multi-site registry study. Patients enrolled in the iATP PAS will be prospectively followed in the registry until registry closure, patient death, or patient exit from the registry (i.e., withdrawal of consent).

Patient and device status will be assessed at least annually or as prompted by reportable adverse events. Remote device data transmissions are recommended to occur at least quarterly. Primary objective analysis will occur when 241 iATP-treated eligible ventricular episodes in the fast ventricular tachycardia (FVT) zone have been collected and reviewed by the study episode review committee (ERC). The total study duration is approximately 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient is intended to receive or is implanted with an iATP-capable device with iATP on in any zone with ventricular ATP therapies programmed.
* Patient is enrolled in the CareLink network for remote device monitoring

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
Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function

Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis Medical Center are currently conducting a study on the effects of vitamin D supplementation during pregnancy on maternal health and immune function. The investigators believe that vitamin D supplementation at levels greater than the current recommendation is beneficial for maternal health during pregnancy. In particular, there is evidence that vitamin D deficiency during pregnancy puts women at greater risk for diseases like pre-eclampsia, which may be due to an imbalance in immune function at the placenta. This randomized, double-blind study is designed to test this hypothesis. Pregnant women who participate in the study receive either 400 IU or 2,000 IU of vitamin D per day for the duration of their pregnancy. The investigators will collect blood at three time points during pregnancy (16-20 weeks, 26-28 weeks, 36 weeks gestation) for analysis of immune function and vitamin D status. The investigators are also collecting data on clinical parameters, such as blood pressure and glucose tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Less than 20 weeks gestation
* Over 18 years of age
* Able to swallow nutritional supplements

Exclusion Criteria:

* Use of medications known to affect vitamin D metabolism
* Diagnosis of type 1 diabetes
* History of thyroid, renal, or liver disease
* Problems with digestion or absorption
Anesthesiology's Practice Time Evaluation

The evolution of the health care system in Western countries has increased the scope of the tasks assigned to doctors in their daily lives. The burden of administrative tasks and the use of IT tools reduce the time spent with the patient. Indeed, in a very recent work published in the Annals of Internal Medicine, Sinsky et al. showed that in 4 different specialties (general medicine, internal medicine, cardiology and orthopaedics) for every hour spent in front of a patient, each physician spent two hours on tasks in the absence of the patient1. This distribution of time was found in the Wenger et al. study in 36 internal medicine interns, since a ratio of 1:3 between the working time spent in the presence of the patient (1.7 hours) and that spent in front of a computer (5.2 hours) was noted2.

The reduction in the clinical time devoted directly to the patient is a major source of dissatisfaction for physicians, which can even extend to burnout3. Moreover, it has been shown that the importance of computer tasks in everyday life is correlated with the occurrence of burnout4. Finally, beyond these clinical times directly or indirectly linked to patient care, the time spent on other tasks (administrative, travel time between different sites,...) appears to be significant (20% in Sinsky et al.)1.

The anesthesiologist faces the same constraints as other specialties, but no work has been specifically concerned with the distribution of time spent on the different tasks. Compared to other specialties, anesthesiologist is also regularly confronted with specific organisational tasks within the operating room that could reduce the time spent directly with patients.

The objective of this work is to determine the division of the different tasks in a anesthesiologist's work day by analysing the time spent directly with the patient but also that allocated to his or her care outside of his or her presence, as well as that devoted to organizational or administrative tasks.


Eligibility Criteria:
Inclusion Criteria:

* Anesthesiologist performing his day's work in an anaesthesia context
* Day including only clinical activity

Exclusion Criteria:

* Anesthesiologist isn't performing a day's work in an anaesthesia context
* Day not only includes clinical activity
Optimization of Ventilator Setting for Acute Exacerbations of Chronic Obstructive Pulmonary Disease

The analysis of flow and pressure curves generated by ventilators can be useful in the individuation of patient-ventilator asynchrony, notably in COPD patients. To date, however, a real clinical benefit of this approach to optimize ventilator setting has not been proven. The aim of the present study was to compare: optimized ventilation, driven by the analysis of flow and pressure curves, and standard setting (same initial setting, same time at the bedside, same physician, while the ventilator screen was obscured with numerical data always available). The primary aim was the normalization of pH at two hours, whilst secondary aims were change in PaCO2, respiratory rate, patient's tolerance to ventilation (all parameter evaluated at baseline, 30, 120, 360 minutes and 24 hours after the beginning of ventilation). 70 patients (26 females, aged 78±9 years, PaCO2 74±15 mmHg, pH 7.28±0.05, mean±SD) have been enrolled, with no basal difference between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients aged \> 40 years affected by COPD exacerbation (defined as an acute change in a patient's baseline dyspnoea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in therapy), and respiratory acidosis (pH \< 7.35) that were treated by NIV in addition to standard medical therapy

Exclusion Criteria:

* The needing of intubation
* The lack of informed consent