cyrilzakka/clinical-trials huggingface dataset:
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment

Studies suggest an association between retinal abnormalities and NCD (Neuro Cognitive Disorders) whether they are linked to proven or prodromal Alzheimer's disease (aMCI : amnestic mild cognitive impairment), or to other neurodegenerative diseases such as frontotemporal dementia or Lewy body diseases.

These retinal anomalies objectified by OCT-A (Optical coherence tomography angiography) and adaptive optics (AO) appear different depending on the pathologies and could therefore serve as markers in vivo of the pathophysiological processes underlying NCD.

No study to date has studied the retina and its vessels in NCD using adaptive optics. In this pilot study, we are proposing a combination of two new ophthalmological imaging techniques (OCT-A and AO), which allow rapid in vivo analysis in a completely non-invasive way of the morphology of small vessels as well as architecture of the retina to better specify the retinal anomalies associated with NCD. We will compare the parameters in OCT-A and AO between patients with NCD and controls without NCD (with memory complaint or without) and will seek to determine if there are different profiles according to the causes of NCD.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting in memory consultation for memory complaint or person accompanying a patient in memory consultation for memory complaint

Exclusion Criteria:

* pregnant or lactating women
* history of known non-degenerative neurological pathology (tumor, stroke territorial, in particular multiple sclerosis)
* history of retinal pathology
* ametropia greater in absolute value than 3 diopters on the sphere, or/and 1.5 diopters on the cylinder.
* history of taking ethambutol for more than 2 months
* history of takingsynthetic antimalarial for more than 2 years
* Mini Mental State Score (MMS) and / or Montreal Cognitive Assessment (MoCA) \<10 for patients and 26 for accompanying persons
* MRI contraindication (for patients only)
A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients

The goal of this 2 step-up, exploratory study is to test safey, tolerability and PK/PD profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage therapy.

The main questions it aims to answer are:

1. whether is it safe and tolerable when healthy volunteers and sudden sensorineural hearing loss patients take multiple doses of NS101 against FAM19A5
2. whether is it effective in reversing hearing capability in sudden sensorineural hearing loss patients who fails to show sufficient recovery despite of oral standard steroid therapy.

Patients and heathly volunteers will be given NS101 15mg/kg or 30mg/kg systemically less than 3 months per protocol.

This is placebo controlled, double blinded study, which means there will be a group who receives placebo (i.e. fake drug) for study purpose.


Eligibility Criteria:
Part A: healthy volunteers

Part B:

Inclusion Criteria:

* unilateral ideopathic SSNHL greater than 55dB at the average of 4 frequencies in PTA (contralateral hearing is less than 30dB)
* those who started standard treatment within 5 days after symptom onset
* those who were treated with oral steroids for 14 days, but incomplete recovery was confirmed as type III/IV according to Siegel's criteria at the end of the 14-day treatment

Exclusion Criteria:

* other otologic or systemic diseases
* retrocochlear lesion
The Ability of Octenilin® to Reduce Odour of Malodorous Wound

Malodours are a common complication of chronic wounds. They are the result of the proliferation of aerobic and anaerobic micro-organisms on the wound surface, where they metabolize healthy tissue which leads to the production of sloughy and even necrotic tissue. Wound odour has a big impact on the quality of life of patients.

Currently the standard of care for the management of malodourous wounds are systemic antibiotics, absorbent wound dressings with or without activated carbon and, topical antimicrobials. The application of topical antimicrobials such as antiseptics against wound odour is part of the standard care. One suggested antiseptic in a recent published standard is Octenilin®. There is ample anecdotal evidence about the efficacy of Octenilin® in reducing wound odour. Therefore, we propose here to document this ability by evaluating the odour of wounds washed with Octenilin® versus standard care (NaCl 0.9% solution).

Malodours are a common complication of chronic wounds. They are the result of the proliferation of aerobic and anaerobic micro-organisms on the wound surface, where they metabolize healthy tissue which leads to the production of sloughy and even necrotic tissue. Wound odour has a big impact on the quality of life of patients. Patients describe living with a chronic malodourous wound as devastating particularly in respect to social interaction. The key to addressing the negative consequences of malodorous and/or discharging wounds is an effective wound managements plan based on accurate and holistic assessment of the patient and the wound.

Currently the standard of care for the management of malodourous wounds are systemic antibiotics, absorbent wound dressings with or without activated carbon and, topical antimicrobials. The application of topical antimicrobials such as antiseptics against wound odour is part of the standard care. One suggested antiseptic in a recent published standard is Octenilin®. Octenilin® wound cleansing solution is on the Swiss market since 2006 and is routinely used in outpatient wound care centers. It exhibits good performance in the reduction of biofilm's pathogens and has excellent moisturizing properties. While there is ample anecdotal evidence about the efficacy of Octenilin® in reducing wound odour, we propose here to document this ability by evaluating the odour of wounds washed with Octenilin® versus standard care (NaCl 0.9% solution).

Eligibility Criteria:
Inclusion Criteria:

* A chronic malodourous wound
* Age over 18 years
* Proficiency in the French language

Exclusion Criteria:

* Valid informed consent is not or cannot be given
* Patients needing dressings with Silver
* Patients needing charcoal dressings
* Patients under antibiotic treatment
Microvascular Ultrasonographic Imaging for the Detection of Early Stage Epithelial Ovarian Carcinoma

In the United States, ovarian cancer is the fifth most common cancer to develop in women and causes more deaths than all other gynecologic malignancies combined. Because of the difficulties in detecting early stage ovarian cancer, 75% of women continue to be diagnosed with advanced stage disease (stage III or IV).

The National Ovarian Cancer Early Detection Program (NOCEDP) as part of the National Cancer Institute's Early Detection Research Network (EDRN) is committed to the development of effective means for the accurate detection of early stage ovarian cancer.

The last decade has seen rapid technological advances in diagnostic ultrasonography with the recent development of three-dimensional imaging.

Initial studies suggest that these new technologies improve upon the diagnostic accuracy of two-dimensional transvaginal imaging in the differentiation between benign and malignant pathology.

This improved diagnostic accuracy may promote improved patient care by separating complex benign masses from ovarian cancer therefore facilitating appropriate treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Women must be greater than 21 years of age
2. Women must have a complex adnexal mass (as defined per ultrasound) which requires surgical intervention

Exclusion Criteria:

1. Known or suspected hypersensitivity to blood, blood products, or albumin.
2. Known history of congenital heart defect that creates a bi-directional or right-to-left shunt.
3. Known history of severe emphysema or a history of pulmonary emboli.
4. known history of severe pulmonary hypertension (systolic pulmonary artery pressures \> 90 mmHg).
Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo.


Eligibility Criteria:
Key Inclusion Criteria include:

1. Female, age ≥18 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
2. Diagnosis of IC/BPS or meets criteria for IC/BPS as defined by the American Urology Association as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes".
3. Subject has Bladder Pain/Interstitial Cystitis Symptom Scale (BPIC-SS) total score of ≥19 and worst bladder pain/discomfort sub-score of ≥4 to ≤9.
4. Has undergone evaluation to rule out other conditions that cause bladder pain/discomfort. Any microscopic or gross hematuria that has not been evaluated in the past 12 months will require appropriate clinical evaluation to determine study eligibility.

Key Exclusion Criteria include:

1. Pelvic floor tenderness in the absence of bladder tenderness on physical examination by primary investigator.
2. Urinary tract infection (UTI) within the past 30 days, or history of recurrent UTI.
3. Hematuria determined to be associated with bladder malignancy or other significant pathology.
4. Had surgical procedure at any time that affected bladder function.
5. Received intravesical therapy or had bladder hydrodistension, fulguration, botulinum toxin, or triamcinolone bladder injection, percutaneous nerve stimulation. A subject receiving such treatment(s) prior to screening is eligible if in the opinion of the investigator the procedure/ treatment resulted in no notable or enduring effect and subject continues to exhibit stable symptomology.
6. Has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis.

Other protocol-specific inclusion and exclusion criteria may apply.
Genetic Assessment of the Patients With Metabolic Syndrome

Metabolic syndrome is a combination of medical disorders that increase the risk of developing cardiovascular disease and diabetes. The exact mechanisms of the complex pathways of metabolic syndrome are not yet completely known. The pathophysiology is extremely complex and has been only partially elucidated. Most patients are older, obese, sedentary, and have a degree of insulin resistance. Stress can also be a contributing factor. The most important factors are:

weight, genetics, aging, sedentary lifestyle,excess caloric intake. In our study we will assess the role of some polymorphisms in the pathology of metabolic syndrome.

Eligibility criteria to the study:

* patients with metabolic syndrome
* with written consent

Eligibility Criteria:
Inclusion Criteria:

* patients with metabolic syndrome according to IDF,AHA and NHLBI 2009

Exclusion Criteria:

* diabetes type 1
* cancer
* not consent
* steroid therapy
* alcohol or drug abuse
* chronic inflammatory disease
* pregnancy or lactation
* severe hypothyroidism
* immunosuppressive treatment
* operation or severe injury during the last month
Efficacy of the Buzzy® Device on the Prevention of Health Care Induced Pediatric Pain in a Vaccination Center

In vaccination centers, venipunctures and vaccinations are sources of pain and anxiety in pediatric patients. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses.

The topical anesthetic cream (lidocaine, prilocaine) and the non-pharmacological (distraction and relaxation) interventions which are usually used for prevention of procedural pain impose certain constraints on families and on vaccination centers.

A distraction and local anesthesia (cold and vibration) based medical device (Buzzy®) could overcome these constraints and could be an interesting alternative for healthcare management in vaccination centers and, in a broader perspective, in other medical services.

Research on this device has been scarce to date. Three of them have shown an efficacy of Buzzy® in comparison to the absence of prevention of vaccination and venipuncture induced pain. An ongoing study will assess the Buzzy® device in comparison to a topical anesthetic cream, but will be set in an emergency department context. To date, no study has compared Buzzy® to topical anesthetic cream on healthy children in a vaccination center.

The research team has formulated the following hypothesis: the Buzzy® device will allow to get a not lower or an equivalent level of pain compared to the level of pain obtained with the usual topical anesthetic cream. The aim of this study is to evaluate the efficacy of the device Buzzy® on vaccination and venipuncture induced pain in a vaccination center.


Eligibility Criteria:
Inclusion Criteria:

Any child who:

* requires a venipuncture or a vaccination in a vaccination center
* is 4 to 15 years old
* is affiliated to the public social security
* speaks French or is assisted by an translator in the language of the child
* has given his oral consent and whose parents have given it

Exclusion Criteria:

Any child who:

* suffers from sickle cell anemia
* has a contraindication to use lidocaine patch
* requires a Bacille de Calmette et Guérin (BCG) vaccine or tuberculin test
* takes part in another research
* has already participated to this study for another nursing care.
* refused to participate or whose parents refused
* has neurological or psychiatric disorders
* has a nerve damage or an abrasion of the skin in terms of puncture or injection area.
* under trusteeship or guardianship (unaccompanied foreign minors).
A Study of JNJ-70033093 (BMS-986177) in Healthy Chinese Adult Participants

The purpose of the study is to characterize the pharmacokinetics of single and multiple doses of JNJ-70033093 (BMS-986177) in healthy Chinese participants.


Eligibility Criteria:
Inclusion criteria:

* Healthy on the basis of physical examination, medical history, vital signs, Electrocardiogram (ECG), and the results of serum biochemistry, blood coagulation and hematology test and a urinalysis performed at screening. If there are abnormalities, investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator
* Must sign an Informed consent Form (ICF) indicating that they understand the purpose of, and procedures required for the study and is willing to participate in the study
* If a woman, except for postmenopausal women, must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta hCG\]) at screening and urine (beta-hCG) pregnancy test on Day -1
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies
* Before randomization, a woman must be either not of childbearing potential; of childbearing potential and practicing a highly effective method of contraception and agrees to remain on a highly effective method throughout the study and for at least 34 days after the last dose of study drug; women must have no history of excessive menstrual bleeding or hemorrhage following pregnancy delivery

Exclusion criteria:

* If a woman, pregnant, breast-feeding or planning to become pregnant during the study
* Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen \[HBsAg\]), or hepatitis C infection (confirmed by hepatitis C virus \[HCV\] antibody), or human immunodeficiency virus type-1 (HIV-1) or HIV-2 infection at study screening
* History of, or a reason to believe a subject has a history of, drug or alcohol abuse within the past 1 year, which in the Investigator's opinion would compromise subject's safety and/or compliance with the study procedures
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) and known allergy to the study drug or any of the excipients of the formulation
* Preplanned surgery or procedures that would interfere with the conduct of the study
Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis

The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other types of MRI may provide a better way to look at lung structure and function in patients with IPF. The ultimate goal is to predict how a particular patient might respond to a particular therapy and to observe such responses earlier than conventional tests. The investigators anticipate that the images acquired in this study will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. "Investigational" means that these tests have not yet been approved by the US Food and Drug Administration and are being tested in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring progression of IPF, therefore, its use in this study is also considered investigational.

Healthy volunteers are being asked to participate in this study because the investigators need to develop a database of functional images that are representative of healthy lungs.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteer (technical optimization)
2. Outpatients of either gender, age \> 18.
3. Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
4. Clinical diagnosis of IPF by established means

Exclusion Criteria:

1. Subject is less than 18 years old
2. MRI is contraindicated based on responses to MRI screening questionnaire
3. Subject is pregnant or lactating
4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
5. Subject has any form of known cardiac arrhythmia
6. Subject does not fit into 129Xe vest coil used for MRI
7. Subject cannot hold his/her breath for 15 seconds
8. Subject deemed unlikely to be able to comply with instructions during imaging
9. Recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids
10. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
Patient Reported Outcomes After Surgery for Rectal Endometriosis

To describe the difference in patient reported outcomes after conservative treatment in comparison to radical rectal surgery in patients with deep endometriosis infiltrating the rectum (up to 15cm from the anus with at least involvement of the muscularis layer) and to determine predictors for radical surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 45 years (both inclusive)
* BMI \<35
* Complaining of infertility and/or pain
* Deep endometriosis infiltrating the rectum on at least one imaging technique up to 15 cm from the anus and involving at least the muscularis layer in depth

Exclusion Criteria:

* Refusal of bowel resection/stoma
* History of laparotomy for endometriosis
* (history of) Hysterectomy
* Suspected pelvic malignancy
* Pregnancy
* Impossibility for postoperative follow-up in our hospital
Effect of Serum Vitamin D Level on the Efficacy of Peg-interferon Treatment in CHB

In recent years, vitamin D (VD) has received much attention in the fields of host immune regulation, inflammation, fibrosis, cell proliferation and differentiation and tumor. VD works by binding to the vitamin D receptor (VDR). VDR is mainly distributed in giant cells, dendritic cells, T cells and lymphocytes. Four SNPs of VDRS have been most studied: TaqI (rs731236), FokI (rs10735810), ApaI (rs7975232), and BsmI (rs1544410). At present, more and more patients have been treated with oral nucleotide/nucleoside analogues (NAs) with direct antiviral drugs in China, and a large part of them show low expression of HBsAg. Clinical cure can be pursued for these patients, that is, HBsAg turns negative. A number of studies have been carried out at home and abroad.

In this study, We will recruit CHB patients with low HBsAg levels. They all will receive pegylated interferon treatment and were randomly assigned to a vitamin D treatment or a control group. A final assessment will be made to determine whether vitamin D levels would affect the clearance rate of HBsAg.


Eligibility Criteria:
Inclusion Criteria:

1.According with the diagnosis of chronic hepatitis B in the guideline of China in 2015 2.18-60 years old 3.More than 1 year history of nucleot(s)ide analogues therapy with HBsAg ≤1500 IU/ml, negative HBeAg and HBV DNA\<100 IU/ml 4.No contraindications of interferon

Exclusion Criteria:

1. Allergy to interferon
2. Alanine transaminase \>10 times of upper limit of normal(ULN) or total bilirubin \>2 times of ULN
3. existing or previous decompensated liver cirrhosis
4. White blood cells or Platelet below the lower limit of normal
5. existing severe organ injury
6. combined with autoimmune diseases, psychiatric diseases, diabetes or thyroidism
7. confirmed or suspected malignant tumors
8. before or after transplantation
9. using immunosuppressor
10. pregnant or having a planned parenthood in 2 years
11. alcohol or drug addicted
12. infected by HIV
13. any conditions that is unsuitable to interferon therapy according to the doctors' judgement