cyrilzakka/clinical-trials huggingface dataset:
Non-exudative Age-related Macular Degeneration

Age-related macular degeneration (AMD) is the most prevalent cause of vision loss in developed countries and is often discussed in terms of the "dry" and the "wet" forms. The "wet" form of AMD is the more advanced form of the disease and is responsible for 80% of the legal blindness in AMD. Treatment options include a promising class of biologics called anti-vascular endothelial growth factors, as well as photodynamic therapy and laser surgery. These therapies can slow further vision loss, but cannot achieve recovery of lost vision. The "wet" form of AMD is always preceded by the "dry" form. Therefore, it is reasonable to expect that the early detection and treatment of the "dry" form may help reduce vision loss or progression to the more damaging "wet" form. Unfortunately, symptoms appear only in advanced stages of the "dry" form. As light sensitive cells in the macula breakdown in a process called geographic atrophy, the patient may notice blurred central vision.

OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging, except that OCT measures the intensity of reflected light rather than acoustical waves.

This study aims is to use OCT technology to compare how the retinal anatomy and blood flow differ within three severity groupings of non-exudative age-related macular degeneration (NEAMD).


Eligibility Criteria:
Inclusion Criteria:

* Presence of mild, moderate or severe NEAMD.
* Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.
* Vision better than 20/200

Exclusion Criteria:

* Inability to give informed consent.
* Inability to maintain stable fixation for OCT imaging.
* A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
* A concurrent ocular pathology that may contribute to vision loss (e.g., CNV, glaucoma, visually significant cataract, optic neuropathy, diabetic retinopathy, history of retinal surgery) or interfere with acquisition of high-quality images
* Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
* An ocular condition is present that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
* Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
* Unable to ambulate and take tram from clinic to where OCT is located
Correlation Between Expression of Hormonal Receptors, Clinical Data, and Methylation Profile in Meningiomas (MethylRH-M)

This research aims to explore the relationship between hormonal receptor expression and the clinical and histopathological characteristics of meningiomas. The underlying hypothesis is that hormonal receptor expression, as well as the methylation profile of their gene promoters, are associated with specific aspects of meningiomas and patients' clinical outcomes. The main objective is to study the correlation between the immunohistochemical expression of hormonal receptors and clinicopathological data. The secondary objectif is to study the correlation between the methylation profile of hormonal receptor gene promoters and their immunohistochemical expression.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent surgery for a meningioma at the University Hospital of Nancy between 2000 and 2022.

Exclusion Criteria:

* Patients who did not express their consent to participate in the study.
* Patients with grade 2 or 3 meningiomas whose samples are no longer available or in insufficient quantity to perform an immunohistochemical study.
* Patients with grade 1 meningiomas not selected by randomization.
* Patients withdrawing their consent.
Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181

The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 15 to 50 years of age each having at least one keloid scar on the ear. (If both ears have keloids, both ears may be treated with E-Matrix).
* Keloids that have not undergone more than two surgical revisions (laser, cryotherapy or surgery)
* Keloids that have been present for ≥ 1 year.
* The keloid must measure ≥ 0.5 cm and not extend onto other portions of the head, neck, or face.
* Able and willing to give written informed consent. (Age 15-17 must have written informed consent of legal guardian).
* Willing to comply with the follow up schedule for a minimum of 6 months.

Exclusion Criteria:

* Subjects with history of prior treatment at the study site or prior treatment of the keloid in the previous 6 weeks.
* Pregnant or planning to become pregnant during the course of the study.
* Heart disease or history of congestive heart failure.
* Advanced or poorly controlled diabetes.
* Current or history of heavy smoking (i.e., 10 pack years)
* Active local infection at the treatment site and/or systemic infection.
* History of or active central nervous system disease.
* History of fever, migraine headaches, and/or recurrent upper respiratory infection.
* Active collagen vascular disease or vasculitis, e.g., systemic lupus erythematosus, polyarthritis, dermatomyositis, systemic scleroderma or thrombotic thrombocytopenic purpura.
* Unwilling or unable to return for follow-up visits.
* Unwilling to refrain from use of any other scar treatment therapy/scar improving product, during the study, including steroid injections.
* Regular, continuous use of systemic corticosteroid therapy or topical corticosteroid use in the area to be treated.
* Current participation or participation within the last 3 months in the study of an investigational drug, device, or biologic.
* Unable or unwilling to follow post-operative instructions.
* Known hypersensitivity to MF-4181, collagen, dextran, or any of its constituent materials.
* Known hypersensitivities to animal-based products
* Previous participation in this study to avoid multiple enrollments of an individual subject.
Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment

Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in two-step indirect pulp treatment: Randomized clinical trial


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years.
* Males or females.
* Co-operative patients approving to participate in the trial.

Exclusion Criteria:

* Patients younger than 19 years old or older than 50 years old.
* Disabilities.
* Systemic diseases or severe medically compromised.
* Lack of compliance.
ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence.

The purpose of this study is to evaluate the impact of anoperineal physiotherapy in adjunction to standard medical treatment on symptoms and quality of life of adults with anal incontinence, in comparison with standard treatment alone.

A total of 443 patients will be randomized to 2 groups: standard care (medical treatment) alone or standard care associated with anoperineal physiotherapy. Outcome measures include the patient own view of the effectiveness of the treatment, the continence score, quality of life and psychological status. These outcomes are measured at the end of the 4 months treatment period.

Following this period, the non responders to standard medical treatment will be proposed to undergo a course of anoperineal physiotherapy and the non responders to anoperineal physiotherapy will be treated by transcutaneous electrical nerve stimulation (TENS). The outcomes will be measured at the end of the 4 months new treatment and again after 4 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75
* Anal incontinence for more than six months.
* Signed informed consent
* Jorge and Wexner's anal incontinence score \> or egal 5

Exclusion Criteria:

* Previous course of anoperineal physiotherapy within the past 6 months
* Anorectal or perineal surgery within the past 6 months.
* Indication for anoperineal surgery
* Vaginal delivery within the past 6 months
* Pregnancy
* Major neurological disease,
* Significant cognitive impairment, dementia or institutionalised.
* Active inflammatory bowel disease.
* Current treatment by sacral nerve neurostimulation.
* Cardiac pacemaker
* Skin damages preventing transcutaneous electrical nerve stimulation (TENS).
Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also the first-echelon nodal drainage site for metastasis and provides important prognostic information in breast cancer patients. The internal mammary sentinel lymph node biopsy (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. But the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical trial is carried out to improve the visualization rate of IMSLN with modified techniques: (1) The radiotracer is injected intraparenchymally into 2\~4 quadrants of breast. (2) The radiotracer is injected in a high volume. (3) The radiotracer should be injected under ultrasonographic guidance.

OBJECTIVES:

* Compare the visualization rate of internal mammary sentinel lymph node in breast cancer patients with different injection technologies.
* Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node -negative in these patients.
* Evaluate the risk factors for internal mammary sentinel lymph node metastasis
* Evaluate the success rate and the safety of internal mammary sentinel lymph node biopsy.
* Draw the learning curve of internal mammary sentinel lymph node biopsy.

OUTLINE:

3\~18 hours before surgery, 99mTc-labeled sulfur colloid was injected under ultrasonographic guidance in different patterns and injection methods were classified according to the number of injection quadrants. Subsequently, lymphoscintigraphy was performed 0.5\~1.0 hour before surgery. During surgery, the sentinel lymph nodes (axillary or internal mammary) were identified by combining the use of intraoperative gamma detector and blue dye. The sentinel lymph nodes (axillary or internal mammary) were analyzed by hematoxylin-eosin staining and immunohistochemistry for future therapy planning.

Eligibility Criteria:
Inclusion Criteria:

* primary breast cancer
* clinically axilla-negative

Exclusion Criteria:

* enlarged internal mammary nodes by imaging
Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women

Through a randomized, crossover, triple-blind, placebo-controlled clinical trial, 15 physically inactive hypertensive women will participate a 8-day trial, each with two intervention protocols: 1) placebo and 2) beetroot; in which will ingest beet juice with or without NO3 in its composition with a 8-day washout interval.


Eligibility Criteria:
Inclusion Criteria:

* 50 to 65 years old
* Physically inactive
* Postmenopausal diagnosis (amenorrhea for 12 months or more);

Exclusion Criteria:

* Smoking
* Cardiac failure
* Previous history of acute myocardial infarction and/or stroke;
* Allergy or intolerance to nitrate, gluten, or milk;
Evaluation of EV1000™/volumeView™ for Cardiac Output Monitoring in Liver Transplantation

The investigators are trying to evaluate the agreement of cardiac output measurements taken using the specific thermistor-tipped arterial catheter ( the VolumeView ™ catheter) and the EV1000 ™ monitoring platform ( Edward lifesciences, Irvine, CA, USA) with measurements taken using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic liver transplantation.

In cirrhotic patient undergoing liver transplantation, there are an altered patterm of circulation, which is characterized by increased cardiac output, decreased peripheral vascular resistance, and reduced ventricular response to physiological, pharmacological, and surgical stress. Large blood loss and clamping/declamping of the inferior vena cava and portal vein during liver transplantation surgery can affect intravascular volume status, which in turn can lead to hemodynamic instability. Therefore, reliable cardiac output monitoring is particularly useful in the cirrhotic patient undergoing liver transplant. Pulmonary artery thermodilution has been used as a standard method for cardiac output assessment for many years. Pulmonary artery catheter can cause rare but serious complications. And it has some limitations for continuously monitoring cardiac output during rapid hemodynamic changes.

Recently, several minimally invasive CO monitors have been developed. The pulse contour technique continuously estimates CO through mathematical analysis of the waveform of arterial pressure. However, previous studies evaluating the reliability of the pulse contour techniques indicated conflicting results in cirrhotic patients during liver transplantation. Most of studies were performed by analyzing from radial artery pressure waveform. Because of rapid changing of intravascular volume, using inotropics, the monitoring of femoral artery pressure has been recommended during liver transplantation.

A new pulse wave analysis system has developed and introduced into clinical practice that consists of a specific thermistor -tipped femoral arterial catheter ( the VolumeView™ catheter) and the EV1000™ monitoring platform ( Edward lifesciences, Irvine, CA, USA). To continuously assess CO based on the femoral arterial pressure curve signal and it uses transpulmonary thermodilution for calibration. We are trying to evaluate the agreement of cardiac output measurements taken using EV1000™ / VolumeView™ with measurements taken using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

subjects undergoing living donor liver transplantation during the study period subjects older than 20yrs who can give informed consent

Exclusion Criteria:

those who are confirmed moderate severe aortic regurgitation by echocardiography those with infection on cannulation site
The Psychological Impact of COVID-19 on Patients with Solid Malignancies: a Single-Institution Survey Study

The COVID-19 pandemic and the subsequent government-imposed restrictions have undeniably resulted in unprecedented changes to the life of patients with cancer. It has become more evident that patients with cancer may be at significant risk of higher morbidity and mortality when infected with SARS-CoV-2, which is understandably causing anxiety amongst both patients and their oncology team.

This project is a single centre, non-interventional observational prospective cohort study; which aims to evaluate the impact of COVID-19 on the mental health and general wellbeing of patients diagnosed with solid malignancies by utilising a range of non-invasive questionnaires (GAD-7, PHQ-9, PC-PTSD-5, WHO-5 and Wellbeing thermometer). Data on patient demographics, treatment and medical history, and medical resource utilization will be obtained through a medical chart review at enrolment for up to 4 months. Participants will be asked to complete five questionnaires regarding their mental health and wellbeing status during their routine clinic visits, but no other additional tests or procedures will be undertaken for the study outside of their routine care.

It is essential to understand both the short and long term psychological consequences of COVID-19 on cancer patients to better inform the institute and other regional and national stakeholders of the scale of the issue, in order to recommend necessary measures and resources required to address this important issue.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or over.
2. Cancer diagnosis
3. Able to fully comprehend the Patient Information Sheet

Exclusion Criteria:

1. Patients who lack capacity to participate.
Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma

Patients will be enrolled in two stages:

* Dose-escalation stage: Approximately 12-24 patients will be enrolled.

Detailed Description:

• Dose-escalation stage : designed as classical 3+3 to determine MTD(Maximum tolerable dose), RP2D(Recommended Phase 2 Dose) and DLT(Dose-limiting toxicity)s to evaluate approximately four dose levels of GX-I7

* pre-determined dose(Level I)\~ pre-determined dose(Level IV)

Eligibility Criteria:
\[Inclusion Criteria\]

1. Ability to understand and willingness to sign a written informed consent document (ICF).
2. Age ≥ 19 years
3. Able to comply with the study protocol, in the investigator's judgment
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

\[Exclusion Criteria\] General Exclusion Criteria

1. Unable to comply with study and follow-up procedures
2. Is pregnant or breastfeeding
3. Have clinically significant cardiac disease (New York Heart Association, Class II or greater) including myocardial infarction, unstable arrhythmias, and/or unstable angina in the past 3 months
4. Have clinically significant liver disease, including alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography

Most patients presenting to hospital with symptoms of a heart attack are sent home without further tests once a heart attack has been ruled out. Current strategies to assess patients with a suspected heart attack involve blood tests to measure troponin, a protein released into the bloodstream when the heart muscle is damaged.

Despite having had a heart attack ruled-out, some patients have unrecognised heart disease and are at risk of having a heart attack in the future. However, clinicians do not know what is the best approach to identify and treat these patients.

This study will use a heart scan known as computed tomography coronary angiogram (CTCA) to look for unrecognised heart disease in patients who have had a heart attack ruled out. In an earlier study, the Investigators performed this scan in patients referred to the outpatient cardiology clinic with stable chest pain and found that this improved the diagnosis of heart disease, leading to improvement in patient care that prevented future heart attacks.

Previous research from the Investigators has also found that troponin levels below those used to diagnose a heart attack may help to identify those who are at greater risk of having a heart attack in the future.

The aim of this study is to find out if patients with these low levels of troponin, where a heart attack has been ruled out, will benefit from CTCA to look for unrecognised coronary heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to hospital with symptoms of suspected acute coronary syndrome
* Age 18 years and over
* Maximum high-sensitivity cardiac troponin concentration between 5ng/L and the 99th percentile

Exclusion Criteria:

* Diagnosis of myocardial infarction during index presentation
* Clear alternative diagnosis or participant requires further inpatient clinical assessment
* Recent CTCA or invasive coronary angiogram (within 1 year)
* Patient inability to undergo CT scanning, e.g. due to severe renal failure (estimated glomerular filtration rate \<30 mL/min) or major allergy to iodinated contrast media
* Current pregnancy or breast feeding
* Inability to give informed consent
* Further investigation for coronary artery disease would not be in the patient's interest, e.g. due to limited life expectancy, quality of life or functional status
* Previous randomisation into the trial
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness

The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652 given once daily to people with excessive daytime sleepiness. Subjects will be randomized to either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.


Eligibility Criteria:
Inclusion Criteria

* Has current diagnosis of an excessive daytime sleepiness disorder, including narcolepsy, idiopathic hypersomnia, and obstructive sleep apnea
* Age 18 to 60 years Exclusion Criteria
* Has significant suicidal ideation
* Has a history of substance abuse
* Has a history of a certain significant medical conditions, including uncontrolled psychiatric diseases or disorders
* Use of certain medications
Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas

The purpose of the study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating advance-stage Hepatocellular Carinoma(HCC).

This is a prospective, multicentre, random, controlled clinical trial of Transcatheter Arterial Chemoembolization (TACE)with KMG Microsphere Treating Advance-stage Hepatocellular Carinomas.

Eligibility Criteria:
Inclusion Criteria:

1. Hepatocellular Carinomas with diagnosis of pathology or cytology or consistent with China 2001 guideline of Clinical Diagnosis Hepatocellular Carinomas
2. clinical stage（The Barcelona Liver Clinic staging system,BCLC B and C)，or can not receive surgical intervention
3. liver function:Child-Pugh A、B
4. PST 0-1（Eastern Cooperative Oncology Group Performance Score ,ECOG）
5. Lifespan≥6 months
6. First time to receive treatment
7. Can accept the follow up
8. informed consent was gotten
9. the number of lesion ≤ 5

Exclusion Criteria:

1. pregnant or lactation woman
2. emotional disturbance
3. serious heart ,lung disfunction or serious diabetes mellitus
4. serious reactiveness infections;（exp:type B or C hepatitis）
5. liver function :Child-Pugh Score C
6. thrombocyte\<6×109/L
7. diffuse HCC
8. widespread metastasis
9. serious atherosclerosis
10. acquired immunodeficiency syndrome;AIDS
11. thrombosis or thrombosis event in 6 months
12. renal inadequacy who need hemodialysis or peritoneal dialysis
13. with other tumors except basal cell carcinoma and carcinoma in situ of cervix
14. serious alimentary tract hemorrhage in 4 weeks