cyrilzakka/clinical-trials huggingface dataset:
PDN Post Market, Multicenter, Prospective, Global Clinical Study

The purpose of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN). This is a multicenter, prospective, observational global study, that will partner diabetes management teams with pain physicians to provide an interdisciplinary treatment regimen for PDN patients. Outcomes will be assessed via standardized assessments.


Eligibility Criteria:
Inclusion Criteria:

To participate in the study, patients must meet all the following inclusion criteria:

1. Have been clinically diagnosed with diabetes, according to the local country diabetes association guidelines, as well as painful diabetic neuropathy (PDN) of the lower limbs refractory to conventional medical management.
2. Average pain intensity (over the last 7 days) of ≥5 out of 10 cm on the Visual Analog Scale (VAS) in the lower limbs at enrollment/baseline.
3. The clinical decision has been made to provide treatment using the Nevro Spinal Cord Stimulation that includes 10 kHz therapy prior to enrollment in the study.
4. Be willing and capable of giving written informed consent.
5. Be willing and able to comply with study-related requirements and procedures and attend all scheduled visits.

Exclusion Criteria:

To participate in the study, patients must not meet any of the following exclusion criteria:

1. Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or peroneal neuropathies), have had a lower limb amputation other than toes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs
2. Have a medical condition or diagnosis that is inconsistent with Nevro's SCS System guidelines in the Physician's Manual for the relevant country, or as per standard clinical practice.
3. Have a medical condition or pain in other areas, not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound the evaluation of study endpoints, as determined by the Investigator (such as primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, peripheral vascular disease, or small vessel disease).
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome

Despite constant progress in in vitro fertilization (IVF) techniques and ovarian stimulation, pregnancy and embryo implantation rates remain modest . The phenomenon of embryo implantation depends both on the embryo itself and on endometrial receptivity

A favorable uterine medium is necessary for embryo implantation, but endometrial receptivity can be negatively affected by ovarian stimulation . Study of endometrial receptivity is especially limited in the context of IVF cycles .

Biopsy of the endometrium cannot be considered during the treatment, and this has encouraged the development and use of ultrasonography and Doppler-like non-invasive methods to evaluate ovarian response to the stimulation and uterine receptivity .

Eligibility Criteria:
Inclusion Criteria:

- Maternal age from 20 to 40 years. Women with BMI range from 20 - 35 Women diagnosed with primary infertility

Exclusion Criteria:

Maternal chronic medical disorder (diabetes mellitus or hypertension). Women diagnosed with autoimmune diseases or antiphospholipid syndrome
Antigen Rapid Test Screening to Prevent SARS-CoV-2 Transmission (COVID-19) at Mass Gathering Events.

To investigate the impact of rapid antigen testing for Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2), the investigators plan to conduct a large trial to assess the impact of using rapid tests to screen people before participating at a mass gathering event, i.e. a music concert. Among participants who wish to attend and fulfill the inclusion criteria, half will be offered access to rapid testing and concert (provided the test is negative), and the other half will not. Allocation will be by randomisation. A week after the concert both groups will be tested by means of a standard PCR-test.

To investigate the impact of rapid SARS-CoV-2 antigen testing on the incidence of COVID-19, the investigators plan to conduct a large trial to assess the impact of using rapid tests to screen people before participating a mass gathering event, i.e. a music concert. The hypothesis is that screening by means of rapid testing eliminates any increase in risk of COVID-19 from attending a mass gathering event.

The investigators will recruit Individuals aged 18-45 years, who wish to attend a specific concert, have not received vaccination or had Covid-19 in the past six months, and are not in any risk group for severe disease. At recruitment, all participants (both concert and no-concert groups) will sign a consent form where they commit to using a contact tracing app, and to allowing the research group to use their data in the Norwegian Emergency Preparedness Register (BEREDT C19). They will also consent to having a COVID-19-test (PCR) conducted 6-8 days after the concert date.

After placing their payment, they will be randomised to be given access to a music concert (concert group), or not (no-concert group). Those who are randomised to the concert group will be tested for SARS-CoV-2 using a rapid antigen test, shortly before the concert. Those who test positive will be excluded from attending the concert and will immediately be offered a PCR-test.

All participants will be instructed to stay at home if they have symptoms of COVID-19 or are in quarantine. Participants who have symptoms or are quarantined at the time of the follow-up test will be offered a test through home visit by a mobile clinic.

Infection control measures will be applied to all concert participants in line with standards established by the sector, e.g. hand hygiene measures and a logistical system that seeks to minimise the risk of transmission during entry to the arena and exit after the concert

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-45 years
* Willingness to be randomised and to have a PCR-test taken a week after mass gathering event (both intervention and control groups)

Exclusion Criteria:

* Vaccinated for COVID-19
* Having tested positive for SARS-CoV-2 the last 6 months
* Risk factors for severe COVID-19
Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)

An open-label clinical outcomes study to determine the safety and efficacy of Sentra AM® and Sentra PM® for post-traumatic stress disorder (PTSD) and Gulf War fibromyalgia (GWF).

Male and female military veterans age 18 to 75 experiencing moderate to severe PTSD symptoms including cognitive dysfunction, sleep disorders and mood disorders.

Open-label internet questionnaire-based clinical outcomes study. 250 subjects. 60 days from enrollment initiation to completion and study close. Sentra AM- two capsules given orally once daily in the morning for 30 days. Sentra PM- two capsules given orally once daily thirty minutes before bedtime for 30 days.

To measure improvement in quality of life determined by the change in short form-36 (SF-36) general health survey.

Improvements in daytime sleepiness determined by the Epworth Sleepiness Scale (ESS), improvement in cognitive and emotional function using the Cognitive emotion regulation questionnaire - short (CERQ-Short), change in PTSD symptoms with the Primary Care - PTSD (PC-PTSD), Psychopathy Checklist- Military (PCL-M). Heart rate variability (HRV) data variation will be measured in a group of twenty subjects.

Eligibility Criteria:
Inclusion Criteria:

1. United States military veterans reporting PTSD and/or Gulf War Illness symptoms at least three months after return from duty.
2. Men and non-pregnant, non-lactating women over the age of 18 and under the age of 75, able to read and understand English-language informed consent.
3. Men and women of child-bearing potential willing to use adequate contraception, not to become pregnant or impregnate their partner for the study duration.
4. Patients who will continue on a stable dose (no less than three months) of other medications they are taking and maintain the same dose throughout the duration of the study.
5. Patients willing to commit to completing all clinical questionnaires and guidelines during study-related procedures.

Exclusion Criteria:

1. Patients who have previously taken Sentra AM or Sentra PM.
2. Patients not fluent in English.
3. Participation in a clinical trial within one (1) month prior to screening.
4. Uncontrolled or unstable serious cardiovascular, pulmonary, gastrointestinal, endocrine or neurologic disorder.
Dexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis

The objective of this study is to determine the safety and efficacy of a dexamethasone iontophoretic transdermal patch for the treatment of pain associated with lateral epicondylitis (tennis elbow).

Detailed Description:

This trial is a randomized, double-blind, placebo-controlled, parallel-group trial in subjects diagnosed with lateral epicondylitis (tennis elbow). Subjects entered into the trial will be assigned to one of four treatment groups. The total duration is up to 13 days of trial participation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with onset of lateral epicondylitis symptoms no more than 12 weeks prior to study entry
* Female patients of childbearing potential must agree to use a medically accepted form of birth control.

Exclusion Criteria:

* Subjects with other medical conditions/injuries of the elbow that would account for pain in the area
* Subjects who would require continuation of current pain medications during treatment
* Must not have received a prior corticosteroid injection for lateral epicondylitis in the affected arm
Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling

Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).

AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified.

The aim of the study is to evaluate prospectively the progression and impact of AS in 500 patients using clinical, biological, echocardiographic and MRI parameters performed annually.


Eligibility Criteria:
Inclusion Criteria:

* Aortic stenosis (peak aortic valve velocity (Vmax) ≥2.5m/s )

Exclusion Criteria:

* rheumatismal or congenital aortic stenosis
* aortic insufficiency (grade \>= 2/4)
* Associated valvulopathy (grade \>= 2/4)
* Angina, syncope, dyspnea NYHA 3-4
* Heart failure antecedent
* Myocardial infarction antecedent
* Severe renal failure
* indication of Aortic Valve Replacement (Surgery or TAVI)
* Cardiac surgery (Aorta abdominal) antecedent
* Complex congenital cardiopathy
Trifocal Intraocular Lens in High Myopic Patients With Different Meta-PM Grading

Study the postoperative visual quality and safety of trifocal intraocular lenses implanted in patients with different levels of myopic maculopathy stages according to Meta-PM staging (stage 0-2).

Cataracts occur in patients with high myopia who are younger than age related cataract patients. These relatively young cataract patients have a higher demand for lens removal, and therefore have a higher acceptance of multifocal intraocular lenses. Some current studies have shown that the implantation of multifocal intraocular lenses in patients with high myopia has achieved good visual effects after surgery. As we all know, high myopia is associated with a higher incidence of postoperative complications, and high myopia macular degeneration can affect postoperative visual effects and patient satisfaction. However, there is no research to evaluate the clinical effect of multifocal intraocular lens implantation in patients with high myopia according to different fundus Meta-PM classifications.Therefore, the purpose of this study is to study the postoperative visual quality and safety of trifocal intraocular lenses implanted in patients with different levels of myopic maculopathy stages according to Meta-PM staging (stage 0-2).

Eligibility Criteria:
Inclusion Criteria:

Age-related cataract 26mm ≤ AL ≤ 30mm Pre-op corneal astigmatism ≤ 1.0 D (IOLMaster 700, Carl Zeiss Meditec AG); Eyes with angle kappa ≤ 0.50 mm (iTrace); Eyes with corneal spherical aberration ≤ 0.30 (iTrace); High order aberration ≤ 0.3 (iTrace). 2.2 ≤ pupil size ≤ 5.5mm Meta-PM classification grade 0, 1 and grade 2 with low risk of MM progression No maculopathy(complete and continuous macular retinal structure revealed by OCT)

Exclusion Criteria:

Combined with Glaucoma, serious fundus pathological change, intracranial tumor Any systemic disease may cause secondary vision impair Synechia Other ocular surgery history history of serious cardiopulmonary or cerebrovascular diseases, and serious mental and psychological diseases Sensitive, anxiety perfectionist Any myopic macular lesion, Posterior staphyloma, any Plus lesions in meta-PM classification, including but not limited to CNV, lacquer cracks, dome-shaped macula, Fuchs spot, etc.
QT Dispersion in Patients With Systemic Lupus Erythematosus (SLE)

QT dispersion can be a useful, simple noninvasive method for the early detection of cardiac involvement in SLE patients with active disease. The investigators therefore recommend cardiovascular evaluation for every SLE patient with an SLEDAI higher than 10.

Objective: Patients with systemic lupus erythematosus (SLE) have increased cardiovascular morbidity and mortality. Although autopsy studies have documented that the heart is affected in most SLE patients, clinical manifestations occur in less than 10%. QT dispersion is a new parameter that can be used to assess homogeneity of cardiac repolarization and autonomic function. We compared the increase in QT dispersion in SLE patients with high disease activity and mild or moderate disease activity.

Methods: One hundred twenty-four patients with SLE were enrolled in the study. Complete history and physical exam, ECG, echocardiography, exercise test and SLE disease activity index (SLEDAI) were recorded. Twenty patients were excluded on the basis of our exclusion criteria. The patients were divided to two groups based on SLEDAI: 54 in the high-score group (SLEDAI \>10) and 50 in the low-score group (SLEDAI \<10).

Eligibility Criteria:
Inclusion Criteria:

* no administration of drugs that would potentially influence QT duration except hydroxychloroquine
* no history of ischemic heart disease, congestive heart failure, atrial fibrillation, bundle branch block or abnormal serum electrolytes
* normal resting ECG and a good-quality ECG recording to measure the QT interval.

Exclusion Criteria:

* moderate or severe valve disease
* atrial fibrillation and other ECG abnormalities
* systolic left ventricular dysfunction (ejection fraction \<50% or left ventricular end diastolic dimension \>5.5 mm
* unreliable identification of the end of the T wave in the ECG and
* known presence of cardiac disease including hypertension, diabetes or coronary artery disease.
The Will Erwin Headache Research Center - Cluster Headache Study

The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia is a prospective, multicenter, observational research network for subjects with Cluster Headache and/or Trigeminal Neuralgia.

The Will Erwin Headache Research Center will assemble a national registry of Cluster Headache patients and will sub-categorize and organize this cohort based on individuating characteristics including but not limited to type and severity of condition, associated symptoms, and medical/psychological issues (e.g., depression, disability, sleep). Detailed evaluations and classification will be completed for each enrolled subject. This will encompass genomic and epigenomic studies, past medical history, imaging reports, and specific physical exam results for each patient. It will also enable the study investigators to match patients with suitable interventional clinical trials.

Similar diseases, such as other paroxysmal hemicrania, SUNCT, SUNA, hemicrania continua, and trigeminal neuralgia may also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a trigeminal autonomic cephalalgia according to the International Headache Classification including episodic cluster headache, chronic cluster headache, episodic paroxysmal hemicrania, chronic paroxysmal hemicrania, episodic short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT), chronic SUNCT, episodic short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (SUNA), chronic SUNA, and hemicrania continua. OR Diagnosis of a trigeminal neuralgia according to the International Headache Classification, including classical trigeminal neuralgia and symptomatic trigeminal neuralgia.
* Able to provide HIPAA authorization to share prior medical records/imaging.

Exclusion Criteria:

* Life expectancy less than 1 year, co-existing disease or other characteristic that precludes appropriate diagnosis of a trigeminal autonomic cephalalgia or trigeminal neuralgia.
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
* Inability or unwillingness of subject or legal guardian/representative to give informed consent.

Inclusion Criteria for Healthy Volunteers:

* Inclusion criteria is willingness to consent and be of age 18 and older
Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL

This study recommends the use of OnLife dietary supplement, which will be followed by a few day before the initiation of PACLITAXEL, for the prevention of PACLITAXEL induced neuropathy. OnLife will be continued one month after stopping chemotherapy.

This would limit the number of PACLITAXEL dose reductions and premature interruptions of this chemotherapy, thus potentially improving the results in terms of antitumor efficacy, while improving the quality of life of patients treated with weekly PACLITAXEL.

This study recommends the use of OnLife dietary supplement which will be followed by a few day before the initiation of PACLITAXEL for the prevention of PACLITAXEL induced neuropathy. OnLife will be continued one month after stopping chemotherapy. This would limit the number of PACLITAXEL dose reductions and premature interruptions of this cehemotherapy, thus potentially improving the results in terms of antitumor efficacy while improving the quality of life of patients treated with weekly PACLITAXEL.

Two treatment arms :

- ARM A : 20 patients included in the placebo arm (Standard chemotherapy with PACLITAXEL + placebo dietary supplement) ARM B : 40 patients included in the experimental arm (standard PACLITAXEL chemotherapy + OnLife® food supplement)

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patient with neo-adjuvant or adjuvant management, with an indication for weekly PACLITAXEL 80 mg/m² for 12 courses.
* Age ≥ 18 years
* Performans Status ≤ 3 according to Karnofsky and life expectancy greater than 6 months
* For patients of childbearing age, effective contraception while taking Onlife®/placebo.
* Patient able to swallow OnLife/placebo® tablets easily
* Patient able and willing to follow all study procedures (including the completion of numerous questionnaires) in accordance with the protocol
* Patient has understood, signed and dated the consent form
* Patient affiliated to the social security system

Exclusion Criteria:

* Patient previously started on PACLITAXEL
* Known allergy to any of the substances in the study product Onlife®/placebo (fish oil product)
* Diabetes
* Exogenous (Alcoholism)
* History of peripheral neuropathy at inclusion and/or presence of sensory and/or motor disorders due to other neurological diseases
* Pregnant or breastfeeding woman
* Other uncontrolled progressive pathologies
* Impossible or random follow-up
* Persons deprived of liberty or under guardianship (including curatorship)
* Inability to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair

The purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulations for this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.

The purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulations for this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.

There will be 144 subjects enrolled, including 72 subjects in the trial arm and 72 subjects in the control arm.

Eligibility Criteria:
Inclusion Criteria:

1. Man or woman aged below 6 years old
2. The expected lifetime of no less than 12 months
3. Patients with congenital heart disease in symptoms of ventricular septal defect, atrial septal defect and tetralogy of fallot who need the surgical repair.
4. Physical conditions and vital signs meet requirements for the surgery.
5. The subjects and/or their guardians sign the written Informed Consent Form.

Exclusion Criteria:

1. Patients with severe visceral diseases in liver, kidney, etc.
2. Patients have unstable vital signs and not suitable for the indications.
3. Patients with severe allergic history (especially allergic to bovine materials)
4. Patients with the past medical history of severe immunodeficiency disease
5. The subject has used or plans to use immunomodulatory drugs for more than half a year.
6. The subject with poor blood clotting function, which is defined as that pre-operative INR or APTT is prolonged over 30% than the reference value without drug intervention, or that blood platelet count is less than 100\*10\^9/L.
7. The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate \[GRF\]\<30mL/min/1.73m2.
8. The subject's ALT or AST level is 2.5 times higher than the upper normal limit or the subject has active liver disease or icterus.
9. The subject has participated in another clinical study within past 3 months or is participating in another clinical study now.
10. The investigator believes that the subject has other reasons unsuitable for inclusion.