cyrilzakka/clinical-trials huggingface dataset:
Contribution of Diffusion MRI in Renal Graft Transplantation

While renal graft outcomes were really improved for the last decade, long time outcomes remains stable. Indeed, at 10 years after transplantation, the renal graft survival rate reaches 50%. The chronic allograft nephropathy is the main cause of renal graft loss. Other features such as acute allograft rejection, delayed renal recovery and anti-human leukocyte antigen (anti-HLA) antibodies are associated with poor renal graft survival prognosis. Renal graft protocol biopsies at 3 and 12 months after transplantation are valuable to detect precociously renal injuries at a reversible stage before clinical manifestation. However, renal biopsy is an invasive examination with hemorrhagic risk. Diffusion MRI could be a non-invasive diagnostic tool allowing the early detection of renal injuries, especially allograft rejection without hemorrhagic risk. This tool could be applied routinely to the renal allograft recipient in replacement of protocol biopsies.

Here, aim of this study is to correlate the results from diffusion MRI of renal graft with pathologic findings from protocol renal graft biopsies.

In this view, the investigators include prospectively all recipients of renal transplantation who beneficiate of a protocol renal graft biopsy without barrier to peform MRI examination. Thus, the investigators exclude patients who are not be able to beneficiate of a MRI examination and patient obstacle to renal graft biopsy.

Expected results are the Banff classification from the histopathologic analysis of biopsies. The expected results for MRI examination are signal intensity, diffusive coefficient, anisotropy fraction and change of the diffusion way. Next, the investigators search an association between these features by statistical analysis (Wilcoxon test, Chi², Fisher, Pearson or Spearman).

The investigators performed this study since 01/06/2014 and projected end-time to 01/06/2017.


Eligibility Criteria:
Inclusion Criteria:

* Renal graft recipient from Reims hospital
* Over 18 years
* With consent

Exclusion Criteria:

* None
The Effects of Processed Whole Orange on Subjective Ratings of Satiety

The study is a human dietary test meal study that is a randomized, controlled, double blind, cross over design with 3 intervention arms that will investigate the subjective ratings of satiety in response to different levels of processed whole orange compared with a sugar-matched isocaloric control


Eligibility Criteria:
Inclusion Criteria:

* Gender: male or female
* Age at start of the study: males and females ≥ 21and ≤ 65 years
* Females taking contraceptive pill or post menopausal
* Body Mass Index (BMI) ≥ 18.5 and ≤ 27 kg/m2
* Apparently healthy: measured by questionnaire, no reported current or previous -metabolic diseases or chronic gastrointestinal disorders
* Reported dietary habits: no medically prescribed diet, no slimming diet within the past 3 months, used to eating 3 meals a day
* Reported intense sporting activities ≤ 10h/w
* Reported alcohol consumption ≤21 units/w Informed consent signed
* Recruitment form filled out

Exclusion Criteria:

* Smoking
* Premenopausal females not taking the contraceptive pill
* Dislike, allergy or intolerance to test products
* Possible eating disorder (measured by SCOFF questionnaire score \>1)
* Eating habits questionnaire score \>14
* Reported medical treatment that may affect eating habits/satiety
* Food allergies or intolerance
Prevalance of non_ Alcoholic Fatty Liver Diseases in Patient With Inflammatory Bowel Diseases Attending Assiut University Hospitals

To assess the prevalance of non_alcoholic fatty liver diseases in inflammatory bowel disease patients and its relation to type of treatment given and disease severity

Inflammatory bowel diseases (IBD) including Crohns disease (CD) and ulcerative colitis (UC) are chronic relapsing disorders that often require long-term therapy and follow up .

They are recognized for their complex pathophysiology that involves innate immune system deregulation and altered microbiome in genetically predisposed individuals. Non-alcoholic fatty liver disease (NAFLD) includes a wide spectrum of disorders, ranging from hepatic steatosis (NAFL) to non-alcoholic steatohepatitis (NASH). NAFLD patients are at high risk for liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). Also NAFLD is typically associated with altered metabolism and metabolic syndrome (MetS).

Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease (CD) patients
* ulcerative colitis (UC) patients

Exclusion Criteria:

* diabetic patients
* BMI equal and more than 30.0-34.9(class I obesity)
Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer

The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults aged ≥ 19 years at the time of informed consent
2. Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
3. Subjects with at least one of the following risk factors for ulcer development at screening.
4. Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.

Exclusion Criteria:

1. Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
2. Subjects who have undergone gastroduodenal surgery or total small bowel resection
3. Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
4. Subjects who have had a malignant tumor in the last 5 years
5. Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs
The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study.

This study aims to examine the effects of an osteopathic treatment on adhesions related to c-sections scars.

The rates of caesarean sections are growing throughout the world, with recent rates (in 2016) in Europe of 25%, in North America of 32.3% and in South America of 40.5%.

The incidence of intra-abdominal adhesions in women undergoing to repeated caesarean sections is constantly increasing.

Labor and surgical time are significantly longer in patients with adhesions compared to patients without adhesions.

Furthermore, it has been estimated that about 10% of patients undergoing cesarean section experience chronic pain.

Despite of the big impact on the quality of life of patients and high cost for public health, treatments for adhesions are mostly surgical.

The identification of non-surgical treatments that aim to reduce cicatricial adhesions' formation is essential to decrease hospitalization times and associated complications.

The purpose of this study is to evaluate the effects of osteopathic treatment and self-massage on scars in women who underwent to a cesarean section. The main aim is to assess whether there is a change in the number, size and vascularization of of cesarean section adhesionsthrough Superb Microvascular Imaging (SMI).

Eligibility Criteria:
Inclusion Criteria:

* primiparous or multipara who have undergone a cesarean section with a completely healed scar will be included.
* women who had first menstruation after childbirth
* Women with or without pain or symptoms related to scarring or the presence of isthmocele will be included.

Exclusion Criteria:

* caesarean section performed in a period less than 6 months and over 3 years
* uterine prolapse
* scar treatments already performed (both manual and medical)
* absence of scar adhesions
Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer

The purpose of this study is to evaluate progression free survival primarily. The secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of TAS-109


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma
* Received prior therapy, at least two regimens, containing a fluoropyrimidine, oxaliplatin, and irinotecan
* Have at least one measurable tumor, as defined by RECIST
* Must be capable of maintaining a central venous line access

Exclusion Criteria:

* Had previous anti-tumor therapy in the 3 weeks prior to study entry
* Have not recovered from all toxicities (excluding alopecia) from prior therapy to baseline or ≤grade 1 prior to study entry
* Have another malignancy in the past 3 years except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of VAY736 in Rheumatoid Arthritis Patients

This study investigated the safety and tolerability of VAY736 administered as single ascending doses of intravenous infusion, subcutaneous injection and repeated subcutaneous injections in rheumatoid arthritis patients.

This study had three sequential parts which investigated the safety and tolerability of VAY736 administered as single ascending doses of intravenous infusion (Part 1), single ascending doses of subcutaneous injection (Part 2), and repeated subcutaneous injections of fixed doses (Part 3), respectively, in rheumatoid arthritis patients. Part 1 was double blind, placebo controlled, with 11 cohorts. Part 2 was open-label study with 2 dosing cohorts. Part 3 was open-label study with 1 fixed-dose cohort.

Eligibility Criteria:
Inclusion Criteria:

* Active disease despite methotrexate treatment 5 to 20 mg/week for Parts 1 and 2; methotrexate treatment 5 to 20 mg/week for Part 3
* Fulfilled 2010 American College of Rheumatolody (ACR)/European League Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis for Part 1 and Part 2. For Part 3, fulfilled 2010 American College of Rheumatolody (ACR)/)/European League Against Rheumatism (EULAR) classification criteria or/and 1987 American College of Rheumatolody (ACR) classification criteria for rheumatoid arthritis;
* Methotrexate ≥ 16 weeks, stable dose ≥ 8 weeks

Exclusion Criteria:

* Previous treatment with a B cell-depleting biologic agent.
* Autoimmune disease other than RA except concurrent Sjogren's syndrome
* Adult juvenile rheumatoid arthritis
* ARA functional class IV disease of ACR Revised Steinbrocker Classification
Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin

Studying the effects of Narrowband Ultraviolet B versus acitretin on psoriatic patients

Compare the effects of Narrowband Ultraviolet B versus acitretin on serum Omentin-1 level in psoriatic patients as case control study by dividing patients into 3 groups: group 1 include patients receive Narrowband Ultraviolet B, group II includes patients receive acitretin (0.5-1 mg/day) and control group. The duration of this study about 3 months after receving those interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes with psoriasis vulgaris.

Exclusion Criteria:

* • Patients with history of malignancies, renal and liver diseases.

  * Patients received NB-UVB phototherapy in the last 6 months.
  * Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.
Validation of a Multi-gene Test for Lung Cancer Risk

The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.

Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.

Eligibility Criteria:
Inclusion Criteria:

* 20 or more pack year smoking history
* clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy

Exclusion Criteria:

* Lung Cancer within 3 months after the date of enrollment
Comparing Relative Peripheral Refraction on Myopia Progression

The investigators will test our hypothesis that parameters on peripheral defocus can regulate eye growth: For instance, the relative peripheral refraction measured by Multispectral Refraction Topography (MRT) would be significant different between two groups: fast speed and slow speed of axial length elongation (myopia progression) for 1 year with 2-3 follow-ups.

The goal of this observation study is to confirm the value of MRT in clinic. Could it predict myopia progression or not? By the parameters on relative peripheral refraction in children myopia, could include any of the following: both genders, 7\~17 years age groups, including healthy volunteers. The main question it aims to answer is:

Is any of relative peripheral refraction parameters measured by MRT could guide the clinics for predict myopia progression? Which parameters from MRT could predict the myopia fast progression at baseline ? There is a comparison between groups. Researchers will compare fast myopia progression group versus slow myopia progression group to see if any parameters differs at baseline.

Participants will be asked to the collection methods (such as spectacles, orhtokeratology, contact lens) and interventions; And each participant would be followed up for at least 2 times in one year to test the axial length and refractive error as well as parameters with MRT.

Visual signals from the surrounding retina play a crucial role in the process of emmetropization in the peripheral area of retina and may be a key factor in the development of myopia.

Peripheral defocus can regulate eye growth, particularly peripheral hyperopic defocus, which is a high-risk factor for promoting eye growth and the onset and progression of myopia.

In recent years, with the establishment of new experimental animal models and the emergence of new detection technologies, the relationship between peripheral defocus and myopia has received increasing attention.

The axial length of the eye is the most important indicator for assessing myopia progression.

About 7000 students from Ningbo would be follow-up for the MRT and their myopia progression for at least 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Will to attend the baseline and all the follow-ups
* Sign the Inform Consent Form
* Could co-operate to ask for the correction and accept the axial length measurement and refraction devices including MRT
* Without eye surgery and trauma history
* His/Her refractive error and axial length could be measured

Exclusion Criteria:

* Without data of primary outcome
* With only one measurement
* Others condition that investigators consider not elilgible
Prospective Study of Sinonasal and Skull-base Tumours Management

This observational prospective clinical study aims to describe the epidemiology, management and outcome of patients with sinonasal and skull-base pathology (tumours and diseases with malignant clinical characteristics) in a tertiary otorhinolaryngology referral centre. The main questions it aims to answer are:

* what is the caseload of patients with the included pathology in our centre
* what are the results of management of these cases
* what are the epidemiological characteristics of included patients
* what is the quality of life of included patients.

Sinonasal tumours and tumours that involve the adjacent skull base are rare entities. However, their management necessitates a special knowledge of ENT areas and specifics of sinonasal anatomy and skull base. Due to the heterogeneity of pathological diagnoses of sinonasal and skull-base tumours, one of the main aims of this study is to provide epidemiological characteristics in our geographical area. Furthermore, to compare with other tertiary referral centres, we will analyse management results, which could improve the management of these diseases. Since the sinonasal area and skull base house several important neuroanatomical structures and senses, we aim to provide an analysis of the patient-reported quality of life.

Eligibility Criteria:
Inclusion Criteria:

* sinonasal and/or skull-base cancer
* sinonasal disease expanding through the skull-base
* the patient's written informed consent

Exclusion Criteria:

* lateral skull-base disease primarily originating in the temporal bone and without central skull-base involvement
Identification of Clinically Significant Markers of ATTRv in Pre-symptomatic Mutation Carriers.

The objective of this prospective observational study is to periodically monitor pre-symptomatic subjects carrying a mutation of Transthyretin (TTR), identified in the context of a family screening of affected proband, through instrumental methods and clinical scales in order to identify the first signs of clinically significant organ involvement by the disease. Healthy asymptomatic carriers will be subjected to regular monitoring through clinical evaluations and instrumental investigations defined by the consensus group (Conceicao et al.) in order to validate the criteria defined by this group to define the onset of the disease. A subgroup of carriers with scales and instrumental tests negative for damage to the peripheral nervous system or cardiac, but with subjective symptoms compatible with the disease, will be subjected to further instrumental tests not indicated by consent.


Eligibility Criteria:
Inclusion criteria

1. Pre-symptomatic carriers of TTR mutation in regular follow-up at the Centres.
2. Signature of the written informed consent.
3. Age not less than 10 years compared to the age of onset of the relative with the youngest age of onset and/or a history of bilateral carpal tunnel syndrome undergoing surgery.

Exclusion criteria

* Other causes of neuropathies (diabetes; MGUS; alcoholism; vitamin deficiency).
* Other causes of hypertrophic heart disease.
JAME, a Wearable Device to Control Tremor

The study is a pilot feasibility study aimed at verifying that (1) tremor can be recognized using an accelerometer placed on the hand area and a data mining algorithm properly trained and (2) TENS applied in the hand area is able to acutely suppress hand tremor respect to the baseline.

The study includes 2 different groups: 9 patients with Parkinson's disease with resting tremor alone at the start of their disease (group1), and 5 patients with Essential Tremor (group2). For both groups, the study protocol includes an initial screening visit, in which, after enrollment, the patient's baseline is defined. The experimental session combines both tremor recording and a TENS stimulation treatment.

During the experimental session, the patient wears two devices able to record the upper limb's motion. These devices are commercially available wearable IMU sensors equipped with a triaxial accelerometer, a triaxial gyroscope and triaxial magnetometer. One device is located on the hand, the other on the wrist of the same upper limb, the dominant one. Patients are asked to perform the tasks of the WHIGET scale at baseline and during two different types of electrical stimulation (in a randomly assigned order).

For the recording part, the primary endpoint is the accuracy of the detection system measured as the number of correct detections of tremor episodes on the total tremor episodes recorded by the system (5 seconds windows). For the stimulation part, the primary endpoint is the reduction of upper limb tremor during the stimulation session compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

* Subject signed the approved Informed Consent;
* Subject is willing and able to complete the study procedures;
* Subject is ≥ 18 years of age;
* Subject has a certain diagnosis of:

  * definite PD, at the start of the disease (respecting the new International Parkinson Disease and Movement Disorder Society diagnostic criteria) and experiences tremor as measured on the UPDRS Part III; or
  * ET;
* Subject has a normal cognitive function (MMSE ≥ 24 or MoCA \>26).

Exclusion Criteria:

* Atypical parkinsonian syndromes - progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, dementia with Lewy bodies, vascular Parkinsonism, and other rare causes;
* Other pre-existing and active major neurological disease;
* Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease;
* Advanced liver, kidney, cardiac, or pulmonary disease, cancer;
* A terminal medical diagnosis consistent with survival \< 1 year;
* Medical implanted devices (e.g. DBS, DUOPATM infusion pump); metal implants; the presence or even a suspicion of metal fragments or moving metal implants in its head or neck, as well as it had prior surgical operations on the head or neck;
* Dermatological lesions in the area to be treated with the electrical stimulation;
* Major drug dependency, including alcohol (in the investigator's judgment);
* Females who are pregnant or lactating;
* Subject had an important head injury in the past
Self-administered Acupressure for Depression

The goal of this clinical trial is to examine the effects of self-administered acupressure intervention for alleviating depressive symptoms among people with depression. It is hypothesized that the self-administered acupressure group would have a great improvement in depressive symptoms as measured by the Patient Health Questionnaire compared with the mental health education group across the 12-week intervention period.

The main questions it aims to answer are:

* Is the self-administered acupressure intervention more effective for alleviating depression and other related outcomes compared to the mental health education group among depressed individuals?
* Is the self-administered acupressure intervention acceptable and feasible for depressed individuals to alleviate depression? Participants will be randomized into self-administered acupressure group or mental health education group based on the group allocation with a 1:1 ratio. Participants will attend two weekly 120-min self-administered acupressure training or mental health education, respectively.


Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents aged 18 to 65
2. Can communicate in Cantonese and comprehend written Chinese
3. Have moderate or above-level depression as measured by the PHQ-9 with a score of 10 or above
4. Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria:

1. Have the PHQ score of 20 or above (referral information to community psychological services will be provided)
2. New onset or change of antidepressant medication or dosage in the last 3 months
3. Previous or current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder as screened using the Chinese version of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders.
4. Have cognitive impairment diagnosed by the Hong Kong Montreal Cognitive Assessment with a score \< 22
5. Skin lesions or infections at the treatment sites
6. Significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3)
7. Pregnant or childbearing potential but not using adequate contraception
8. With any major medical condition that causes depression based on the judgement of a psychiatrist.