cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Multi-Periscopic Prism Glasses for Hemianopia

This clinical trial will evaluate the efficacy of two types of high-power prism glasses that provide field of view expansion for patients with homonymous hemianopia (the complete loss of half the field of vision on the same side in both eyes).

Patients with hemianopic field loss may be unaware of objects in their blind (non-seeing) hemi-field and often experience difficulties with hazards, such as walking into obstacles on the side of the field loss. Prism glasses that provide field of view expansion may be helpful in detecting hazards on the blind side. In this clinical trial, two types of high power prism glasses will be evaluated. A new design of prisms, Multi-Periscopic Prisms (MPP), will be compared to commercially-available permanent Fresnel peripheral prism (FPP) glasses. The extent to which the prismatic devices improve detection of hazards on the side of the field loss and are helpful when walking will be evaluated.

Participants will try each type of prism glasses at home for 4 weeks in counterbalanced order. Prism glasses will be fitted by Low Vision Practitioners at vision rehabilitation clinics. Participants will attend in-office study visits before and after wearing each type of prism glasses. At the in-office visits they will complete a test that involves detecting pedestrian hazards in a video simulating a walk through a busy shopping mall (virtual reality, VR, walking simulator test). In addition, they may be asked to complete questionnaires to record their experiences of using the prism glasses.

After wearing the second pair of prism glasses, participants will be asked to complete a questionnaire comparing the two types of prism glasses and to select their preferred type. A clinical decision will be made as to whether the participant should continue to use either the first or second pair of prism glasses (e.g. if a participant finds one pair of prism glasses helpful for obstacle avoidance when walking). For participants who continue with the prism glasses, telephone follow-up interviews will be conducted after about 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Homonymous hemianopia with or without macular sparing for at least 3 months
* Visual acuity of at least 20/50 in each eye, with correction if needed
* Refractive error in the -12D to +5D range
* Able to walk independently, using a cane or walker if needed
* Able to communicate in English sufficiently to understand the study procedures and how to use the prisms

Exclusion Criteria:

* Central visual field loss in the seeing hemifield of either eye (e.g. from macular degeneration, glaucoma, diabetic retinopathy or other maculopathies)
* Hemi-spatial neglect
* Significant cognitive impairment
* Dementia
* Any other physical or mental disabilities, or general health problems that could impair the ability to be independently mobile (i.e., walk ), participate in the VR walking simulator test or use the prism glasses
Design Of WELL Being Monitoring Systems, Application in Autism

The worldwide prevalence of autism is constantly increasing. People with autisms have difficulties in communication and social interaction resulting from atypical perceptual and information processing, leading to the accumulation of anxiety. Extreme overloading experienced internally may not be visible externally. Identifying stressful situations at an early stage may avoid socially problematic behavior from occurring, such as self-injurious behavior. Activation of the autonomous nervous system (ANS) is involved in the response to anxiety, which can be measured through heart rate variability and skin conductance with the use of a portable device, non-intrusively and pain-free. Thus, developing innovative analysis of signal perception and reaction is necessary, mainly for the non-communicative individuals with autism.

The protocol will take place in real life (home and social environments). We aim to associate modifications of ANS with external events which will all be recorded in a synchrony manner through a specific design (spy glasses with video/audio recording). Four phases will be carried out on autism participants and aged-marched controls: 1) 24-hour baseline pre-experiment (physical activity, sleep), 2) 2-hour in real life situation, 3) 30-minute in a quiet environment, interrupted by a few seconds stressful sound, 4) an interview to get comments and feelings about events that triggered anxiety. Autism and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events. We will apply the statistical analyses developed by our team on continuous ANS data. Detection of abrupt changes will allow segmenting the data in shorter time series of few minutes with a constant mean, and estimating their persistency or antipersistency through a piecewise constant fractal index. We will disentangle classes characterizing different behaviors such as anxiety, rest and physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Clear autism spectrum disorder, based on the autism diagnostic interview - revised (ADI-R), the autism diagnostic observation schedule - generic (ADOS-G), and the Vineland adaptive behavior scales (VABS).

Exclusion Criteria:

* change in medical prescription in the previous 3 months and during the experiment.

The same inclusion criteria will apply for the paired age and sex matched individuals with the exception of autism spectrum. The paired control will be chosen within the friends of individuals with autism. In case of difficulty to recruit controls, the psychologist referent may be served as control.
Rectal Cancer Staging Using Whole Body MR-PET

The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative imaging modality in patients with rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients newly diagnosed with rectal cancer on colonoscopy or sigmoidoscopy, who are potentially eligible for neoadjuvant chemoradiotherapy.
2. Patients who sign informed consent.

Exclusion Criteria:

1. Patients who are contraindication for CECT
2. Patients who are contraindication for MRI/CE-MRI
3. patients who are diagnosed with Tis or T1 cancer after polypectomy or EMR
4. Patients who were already diagnosed with an active other cancers.
5. Premenopausal female patients who are pregnant.
6. Patients with fasting serum glucose level (\>200mg/dL) on blood glucose meter prior to WB MR-PET.
7. Patients who are physically compromised to undergo WB MR-PET.
Periodontal Disease and Salivary Mitofusin Levels

The aim of this observational study is to find out whether there is a level difference in salivary mitofusin-1 and mitofusin-2 levels due to changes in periodontal status. The main question it aims to answer is:

* Do salivary mitofusin-1 and mitofusin-2 levels of periodontitis patients differ from healthy patients?
* Could salivary mitofusin-1 and mitofusin-2 levels be biomarkers for periodontal disease?

Biochemical analysis will be performed on saliva samples taken at once from gingivitis or periodontitis patients and healthy individuals who apply to the periodontology clinic, at the initial stage of the treatment. There is no ongoing monitoring or second sampling.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18 and 65.
* Willing to participate in the study and provide a saliva sample.
* Having a healthy periodontal condition, gingivitis, or periodontitis (Stage 3-4, Grade C).
* Having fasted from any food or drink (except water) for the past 2 hours prior to providing the saliva sample.
* Having refrained from brushing teeth or using mouthwash in the past 2 hours prior to providing the saliva sample.
* Not having any systemic diseases.
* Not currently taking any medications regularly.

Exclusion Criteria:

* Having used antibiotics within the last 6 months.
* Having received periodontal treatment within the last 6 months.
* Having fewer than 20 teeth (excluding third molars).
* Having any systemic diseases.
* Not smoking or having quit at least 5 years ago.
Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients

The purpose of this study is to determine whether a drug named Fluvastatin is beneficial and safe in reducing the risk of cardiovascular disease and blood clots in patients with antiphospholipid antibodies or Antiphospholipid Syndrome (APS).

The primary objective of the study is to determine the effects of fluvastatin on pro-thrombotic and pro-inflammatory markers in aPL-positive lupus and non-lupus patients (primary endpoint) and to determine the safety of fluvastatin in aPL-positive lupus and non-lupus patients (secondary endpoint).

All eligible patients will sign an IRB-approved consent form during the screening visit and give blood for baseline laboratory tests. Within a week of the screening visit, all patients will be started on Fluvastatin 40 mg daily for three months. At three months patients will be instructed to stop the study medication and they will be followed for another three months. Thus, the total duration of the study is six months: first three months is interventional and the last three months is observational.

Eligibility Criteria:
Inclusion Criteria:

* Persistently antiphospholipid-antibody positive patients (positive lupus anticoagulant test, anticardiolipin antibody ≥ 40 GPL /MPL, and/or anti- β2-glycoprotein I antibody \> 20 SGU/SMU) with or without systemic lupus erythematosus

Exclusion Criteria:

* Younger than 18 year-old
* Pregnant
* Planning to get pregnant within the next 6 months
* Taking other cholesterol lowering agents
* Taking other immunosuppressive medications (such as methotrexate, azathioprine, cellcept, enbrel, remicade, or rituximab)(Hydroxychloroquine \[Plaquenil\] during the study period is allowed).
* Treatment with biologic agents including anti-TNF medications and Rituximab
* Treatment with erythromycin, itraconazole, or clarithromycin
* Taking prednisone higher than 10 mg daily
* Taking non-steroidal anti-inflammatory drug (such as Motrin, Advil, etc) regularly
* Have a muscle or liver disease
* Have chronic renal disease requiring dialysis
* Have hepatitis C and/or HIV infection
* Have active infections requiring antibiotics
* Have the diagnosis of a systemic autoimmune disease (such as rheumatoid arthritis or systemic sclerosis) other than lupus
* Have diagnosis of another chronic condition requiring corticosteroid treatment more than 10mg daily
* History of an allergic reaction to cholesterol lowering agents
SIMIDIS: Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome

The primary objective is to evaluate the efficacy of the treatment in response rate terms. Otherwise this study wants to evaluate the safety of the treatment.

A total of up to 30 patients diagnosed of myelodysplastic syndrome red cell transfusion dependent with low or intermediate -1 risk will be included.

The patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment, Treatment and Follow up.

The Pre-treatment includes Screening and baseline visits. After providing informed consent, patients will be evaluated for study eligibility.

During Treatment Period patients will be evaluated once a month although biochemistry and haematology parameters will be evaluated every 2 weeks.

If an erythroid response after 24 weeks is determined, a extension treatment will be carry out without disease progression.

Eligibility Criteria:
Inclusion Criteria:

1. Must voluntary sign the informed consent.
2. Age ≥ 18 years.
3. Must be able to comply with the protocol requirements
4. Patient recently diagnosed with Myelodysplastic syndrome red cell transfusion dependent with low or intermediate -1 risk according IPSS criteria.
5. Red cell transfusion dependent anemia.
6. El patient has to be able to complain with the protocol visits.
7. Women and man must accept to use high efficacy anticonceptive methods

Exclusion Criteria:

1. Pregnancy or breast-feed women.
2. Patients previously received treatment with azacytidine .
3. Patients previously received treatment with erythropoietin agents.
4. Proliferative Chronic myelomonocytic Leukaemia (leukocytes ≥ 12000/mL).
5. Patient with a previous clinical history of another cancer (except for basocellular carcinoma or spinocellular carcinoma in situ of cervix or breast) except if the patient is free of symptoms during ≥ 3 years.
6. Cytotoxic chemotherapy or experimental agents usage for myelodysplastic syndrome treatment during 28 days.
7. Previous haematopoietic transplant.
8. Mielosupresion and antitumoral treatment during the previous 28 days.
9. The following laboratory data:

   Absolute neutrophil count \< 1000 cel/ml (0.5x 109L) Platelet count \< 50000/μL (25 x 109/L) Creatinine \> 2.0 mg/dL (177 mmol/L) Aspartate transaminase (AST) or Alanine transaminase (ALT ) \> 5 x the upper limit of normal. Total bilirubin: \> 2 mg/dL
10. Patients with B12 vitamin, folic acid and ferrum deficiency.
11. Patient with positive VIH-1.
12. Any other organic or mental illness that could make impossible to sign the Inform consent or involve risk to the patient.
13. Patient has hypersensitivity previous to beta ,azacytidine, erythropoietin and/or mannitol.
To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea

The goal of this clinical trial is to compare the efficacy of four different drugs in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is:

* Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea?

Participants will be divided into 3 treatment groups.

* Each group will be given a combination of drugs for 2 weeks
* At the end of study, efficacy of different drug combinations and their potential side effects will be compared between the treatment groups

The goal of this clinical trial is to compare the efficacy of four different drugs (Rifaximin , Mebeverine, Amitriptyline and Psyllium Husk) in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is:

• Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea?

Total of 162 Participants will be enrolled in study.

* Participants will be divided into 3 treatment groups i.e. Group A, Group B and Group C.
* Participants of Group A will receive drug combination of Rifaximin and Mebeverine
* Participants of Group B will receive drug combination of Rifaximin and Amitriptyline
* Participants of Group C will receive drug combination of Rifaximin and Psyllium Husk
* Each group will be given a combination of drugs for 2 weeks

Stool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention

Data will be collected using Questionnaire. Questionnaire will be filled by the researcher

SPSS will be used for analysis of data and appropriate test like Chi square Test, Student T test and One way ANOVA will be used to draw conclusions about the efficacy of different drug combinations and their potential side effects between the treatment groups

Eligibility Criteria:
Inclusion Criteria:

Individual of both gender between the age of 18-50 years Diagnosed case of Irritable Bowel Syndrome associated with Diarrhea

Exclusion Criteria:

* Presence of co morbid diseases
* Coronary Artery Disease (CAD)
* Chronic Obstructive Pulmonary Disease (COPD)
* Congestive Heart Failure (CHF)
* Patients taking drugs which modify or aggravate symptoms of IBS (antidepressants, calcium channel blockers etc.)
* Patients having hyperthyroidism \& gluten hypersensitivity
* Patients with alarming symptoms, viz. history of fever, passage of blood in stool, loss of weight, any organic gastrointestinal disease in the recent past
* Patients with recent change in bowel habits, patients on any other concomitant medication for abdominal pain, bowel disturbance or altering gastrointestinal motility and malignancy of any other organ
* Patients with Irritable Bowel Disease and Celiac disease
Genetic Information as a Life Style Change Motivator

The study investigates whether information on having a risk genotype (ApoE4) and life style advisory information affects lifestyle changes and sensory preferences. The project studies also the ethic aspects of giving the information of risk genotype.

We will run intervention based on our earlier pilot study. It includes intensive intervention and a modification of our earlier pilot intervention. Our intervention methods are general lectures of the effects of healthy diet (Finnish Nutrition Recommendations 2014) and healthy lifestyle for all participants. Effects on motivation, attitudes and preferences will be studied and verified by questionnaires and risk factors of cardiovascular disease and Alzheimer disease by analyzing clinical markers of lipid metabolism, general phenotype markers and profiles of nutritional markers. Nutritional biomarkers will verify also the self-reported changes of diet in the questionnaires and in digital food diaries.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 60 years
* overall good health (no chronic conditions e.g. mental disorders, cancer, liver or kidney disease, current or previous diagnosis),
* body mass index (BMI) under 35 kg/m2,
* blood pressure under 140/90 mmHg (medication allowed),
* serum total cholesterol under 7.25 mmol/l (medication allowed)
* fasting plasma glucose level under 7 mmol/l.

Exclusion Criteria:

* Abnormal values of the alanine amino transferase, alkaline phosphatase, haptoglobin and thyroid stimulating hormone
An fMRI Study of Attention and Effort After Concussion

Approximately 1.1 million people a year suffer a mild traumatic brain injury (MTBI), or concussion, in the United States. Although most MTBI patients fully recover, as many as 28% have physical, cognitive, and/or emotional symptoms up to 6 months post-injury. When symptoms persist past three months, it is known as post-concussion syndrome (PCS). The cause of PCS is unknown, as structural neuroimaging and neuropsychological (NP) testing results are often normal. However, recent functional magnetic resonance imaging (fMRI) research in concussed adults showed differences in brain activity compared to controls on working memory tasks, despite normal structural MRI and neuropsychological findings. We propose improving this research by assessing brain activation patterns during simple versus complex attention and working memory tasks in 10 concussed adults via fMRI. This will be the first study to examine brain activation patterns associated with the degree of effort applied to testing, a factor known to confound interpretation of NP test performance. Validated computerized measures of selective attention (Modified Stroop Interference Task), working memory (n-back), and effort (Green's Medical Symptom Validity Test; MSVT) will be used. Ten paid controls will be used for comparative purposes. We hypothesize that concussed patients will show less brain activation than controls on complex versus simple working memory tasks and that activation patterns in concussed patients will generally be lower in those with suboptimal effort. We will also characterize self-reported emotional and physical symptoms in the PCS patients, which has not been done in prior fMRI research with this population.


Eligibility Criteria:
Inclusion Criteria:

* Mild TBI (based on criteria of the American Congress of Rehabilitation Medicine)
* Aged 18 to 60
* History of non-penetrating head injury
* Obtaining medical assistance (e.g., personal physician, Emergency Room) within 24 hours post-injury

Exclusion Criteria:

* No prior history of prior post-concussion syndrome (i.e, uncomplicated mild TBI)
* Moderate to severe TBI
* Substance dependence
* Learning disorder
* Attention-deficit disorder
* Mental retardation
* Severe psychiatric disorder requiring hospitalization
* Previous central nervous system disease
* Absence of neurosurgery
* No evidence of alcohol/drug use related to the injury
Impact of Human Papillomavirus Carriage on IVF/ICSI Results (HPV AMP)

The prevalence of the papilloma virus in the general population is 12%. This virus is known to impair male fertility but its impact on female infertility remains uncertain. This is a public health problem since there is a vaccination protocol. Demonstrating the impact of the human papillomavirus on fertility would be an argument in favor of vaccination.

This is a single-center prospective study in the assisted reproduction center of Brest University Hospital. All new patients coming to consult will be offered participation in the study. The HPV test will be updated if it is older than 12 months. We will analyze stimulation results and pregnancy outcomes according to HPV status. Inclusions will take place over 3 years

Eligibility Criteria:
Inclusion Criteria:

* all etiology of infertility AMH \> ou = à 1.1 ng/ml First ou second protocol of IVF between 25 years and 37 years and 11 months

Exclusion Criteria:

Age \< 25 y Age \> ou = 38 y AMH \< 1.1 ng/ml patient under juridic protection rejection of participation
Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis

This is a study prospectively enrolling adolescent idiopathic scoliosis (AIS) patients and try to find how the age will impact the surgical outcome of AIS.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent idiopathic scoliosis patients; undergoing posterior correction surgery; with minimum 5 years follow-up; with full-spine radiography.

Exclusion Criteria:

* with spinal tumor; with hip disease; without quality of life measurements.
An Integrated Radio-immunological Approach

The most aggressive primary brain tumors in adults, glioblastomas, are characterized by a profound local and systemic immune suppression. During tumor progression, the infiltration of inflammatory leukocytes, especially of myeloid origin, endowed with immunosuppressive function is observed. Aim of this study is to evaluate myeloid cell infiltrate and iron metabolism in tumor-associated macrophages by combining a multimodal MRI imaging technique with immunophenotyping of the tumor microenvironment.


Eligibility Criteria:
Inclusion Criteria:

* All patients with histologic confirmation of malignant glioma
* Patients must be age \>= 18 years
* Patients must be able to obtain an MRI scan with gadolinium contrast
* Patients must sign informed consent indicating that they are aware of the investigational nature of this study: