cyrilzakka/clinical-trials huggingface dataset:
Gut-Associated Lymphocyte Trafficking

The gut immune barrier is not fully restored in HIV-1-infected subjects despite they were receiving antiretroviral treatment. This leaky gut leads to microbial translocation from the gut lumen into the bloodstream that fuels deleterious systemic inflammation. The chemotaxis axes that allow T lymphocytes to migrate from the blood to the gut mucosa in order to reconstitute the mucosal immune barrier seems altered in treated HIV-1-infected subjects.This study aims at better understanding the mechanisms involved in this lack of mucosal immune restoration.

Pathophysiological study in human subjects, comparative, national, multicentric and prospective. Peripheral blood and intestinal biopsies will be collected.

Eligibility Criteria:
Inclusion Criteria are:

For HIV-1-infected subjects group :

* Age at least 18-year old
* HIV-1 infection
* Receiving continuous cART for ≥ 12 months, started during the chronic phase
* Plasma viral load ≤50 copies/mL for ≥ 6 months (one blip ≤200 copies/mL authorized)
* Blood CD4+ T cells count ≥ 350 cells/mm3
* Indication for upper and/or lower digestive endoscopy
* Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme)
* Written informed consent.

For uninfected control group :

* Age at least 18-year old
* Indication for upper and/or lower digestive endoscopy
* Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme)
* Written informed consent

Exclusion Criteria are:

For HIV-1-infected subject group :

* HIV-2 infection
* Inflammatory bowel diseases (Crohn's disease, ulcerative colitis) ; coeliac disease
* Platelets count \<50 G/L or abnormal hemostasis tests
* Decompensated cirrhosis
* Past or current lymphoma
* Involvement in an HIV-1 immunotherapeutic vaccine study
* Pregnant or breastfeeding women
* Subjects participating in a study excluding participating in another study
* Vulnerability, such as an age under 18, tutorship, trusteeship, or subjects deprived of liberty by a legal or administrative decision.

For uninfected control group :

* HIV-1 and 2 infection
* Inflammatory bowel diseases (Crohn's disease, ulcerative colitis) ; coeliac disease
* Platelets count \<50 G/L or abnormal hemostasis tests
* Decompensated cirrhosis
* Past or current lymphoma
* Pregnant or breastfeeding women
* Subjects participating in a study excluding participating in another study
* Vulnerability, such as an age under 18, tutorship, trusteeship, or subjects deprived of liberty by a legal or administrative decision
Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

This study will assess the complete clinical response (no clinical evidence of remaining disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal opening after radiation therapy given at the same time as chemotherapy over a 6 week period, followed by chemotherapy alone given three times over an additional 9 weeks. Follow-up begins with an examination at the end of treatment (at 15 weeks), with ongoing follow-up every 4-6 weeks for one year.

Research has shown that low rectal cancer treated with neoadjuvant chemoradiation (54Gy concurrent with 3 cycles of 5-FU/Leucovorin) followed by 3 additional cycles of 5FU/Leucovorin, followed by close follow-up (every 4-6 weeks for one year)has had good success in achieving complete clinical response, avoiding surgical intervention. If at follow-up remaining disease is found or if there is recurrent disease, surgery can be performed.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* tumor potentially resectable en bloc; tumors tethered or fixed to a structure that can be removed
* clinical/radiological stages T2,T3,or T4, N0-1
* ANC \>1500, PLT\>100,000
* AST and alkaline phosphatase \< 2.5 X ULN
* bilirubin \< 1.5 X ULN
* CrCl \> 50 ml/min using Cockcroft-Gault formula
* KPS \>60
* ECOG Performance Scale 0-2
* No malignancies within previous 5 years other than non-melanoma skin cancer, in-situ cervical cancer, in-situ ductal breast cancer
* no evidence of metastatic disease

Exclusion Criteria:

* initial tumor fixation to pelvic bone or side wide; technically unresectable disease
* any evidence of distant metastasis
* perforation
* obstruction
* hereditary non-polyposis colorectal cancer
* synchronous primary colon carcinomas except T1 lesions
* known dihydropyrimidine dehydrogenase deficiency
* prior radiation therapy to the pelvis
* prior chemotherapy for malignancies
* known existing uncontrolled coagulopathy
* pregnancy or lactation
* women of childbearing potential not using reliable and appropriate contraceptive method
* serious, uncontrolled concurrent infection(s)
* participation in any investigational drug study within 4 weeks preceding the start of study treatment
* clinically significant heart disease
* other serious uncontrolled medical conditions that might compromise study participation (in the investigator's opinion)
* major surgery within 4 weeks prior to the study treatment
* lack of physical integrity of the upper GI tract or malabsorption syndrome
Virtual Peer-to-Peer (VP2P) Support Mentoring for Juvenile Idiopathic Arthritis (JIA): A Pilot RCT

Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes and quality of life in adolescents with Juvenile Idiopathic Arthritis

The aim of this project is to develop and examine the impact of a virtual peer support program on health outcomes and quality of life of adolescents with Juvenile Idiopathic Arthritis using a waitlist randomized controlled trial. In addition to standard medical care, adolescents in the experimental group will receive a manualized peer mentorship program that will provide modeling and reinforcement by trained young adults aged 16-25 years who have learned to function successfully with their pain. Mentoring sessions consist of 10 sessions of 30-45 minute Skype calls over 8 weeks. Feasibility of the program will be measured in addition to quality of life, physical and emotional symptoms, pain coping, self-efficacy, social support, and self-management skills.

Eligibility Criteria:
Inclusion Criteria:

* males and females 12-18 years old
* diagnosed with Juvenile Idiopathic Arthritis (JIA) by a Rheumatologist (any sub-type)
* able to speak and read English
* access to Internet connection, computer capable of using free Skype software
* willing and able to complete online measures

Exclusion Criteria:

* significant cognitive impairments
* major co-morbid illnesses (i.e., psychiatric conditions) likely to influence HRQL assessment
* participating in peer support or self-management interventions (e.g., Teens Taking Charge).
Nutritional Supplement's Effects on Cognition

This is a prospective, placebo controlled study, examining the effects of dietary supplement's effects on cognition and confirming safety.

The objective of this prospective, placebo controlled, double-blinded, parallel-group study is to examine the effects of dietary supplement containing grape juice extract, astaxanthin, and vitamin E over 12 week consumption on cognitive performance and self report results based on questionnaires. Furthermore, an evaluation of general well-being, mood, markers of oxidative stress, neurogenesis (BDNF), eye health, skin health, skin carotenoid concentrations, and safety measurements will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Health Individuals
* Residing in independent living accommodations
* Subjective report of memory or attention problems by answering 'yes' to the following questions: Do you have problems with your memory, attention, or concentration?
* Non-smoker
* Body Mass Index (BMI) between 18-35 kg/m2
* No plan to commence new treatments over the study period
* Understand, willing and able to comply with all study procedures
* Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the study

Exclusion Criteria:

* Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer's Association (NIA/AA) criteria
* A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M)
* Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/malignancy
* Diagnosis of a psychiatric disease (other than mild-to moderate depression of anxiety) and/or neurological condition/disease (e.g. Parkinson's, Alzheimer's disease)
* History of paralysis, stroke or seizures or head injury (with loss of consciousness)
* Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibiters, or steroid medications.
* Taking vitamins or herbal supplements that are reasonably expected to influence study measures
* In the last 6 month, commenced or changed the dose of nutritional and/or herbal supplements that may impact on treatment outcome
* Alcohol intake greater than 14 standard drinks per week
* Current or 12-month history of illicit drug abuse
* Pregnant women, women who are Brest feeding, or women who intend to fall pregnant
* Any significant surgeries over the last year
* Planned major lifestyle change in the next 3 months
Impact of Early Intensive Stimulation on Bimanual Function in Infants at High Risk of Unilateral CP (BB-BIM)

The aim of this study is to measure the impact of early bimanual stimulation in babies with clinical signs of underuse of one hand. The observation focuses on the developmental curve of hands use. The intervention is provided by the family environment and takes place in the child's familiar surroundings.

Congenital hemiplegia, often referred to as Unilateral Cerebral Palsy (UCP), is characterized by a unilateral or asymmetrical brain injury that occurs around birth and impacts the development of manual skills and motor abilities of one side of the body.

Affected children frequently develop hemiplegia with major limitations in the use of their impaired hand, resulting in poor bimanual coordination, thus impacting the performance of daily activities at home, school and in the community.

Several intensive therapy approaches currently exist, including the bimanual approach (BIM) which aims to improve the use of the affected hand as an assisting hand in daily functional activities. These approaches have long been established as effective, however, with these children reaching 90% of their potential gross motor skills around the age of 5, or even earlier in some cases, there is a growing interest in earlier approaches, well before school age. It has also long been established that during the first year of life, there is a critical time frame for hand motor development.

The investigators have thus set up an intensive bimanual stimulation program for infants showing early signs of UCP, delivered by the family environment, in the child's familiar surroundings, under the guidance of a therapist, over a period of 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Baby between 3 and 12 months of age at the time of inclusion
* Clinical signs of underuse of one of the two upper limbs, (reported by the parents and authenticated by the HAI)
* Unilateral brain injury
* Brain imaging performed at birth or upon initial parental concerns
* Possibility of a home visit by the occupational therapist
* At least one parent volunteering to actively participate in the intensive stimulation
* Parental consent to enter the study
* Consent for image rights

Exclusion Criteria:

* Prematurity
* Lack of interest suggesting underlying associated disorders
* Active epilepsy
Quality of Life of Older Patients Who Are Undergoing Treatment for Cancer and of Their Family Caregivers

RATIONALE: Studying quality-of-life in patients having cancer treatment and in their caregivers may help identify the intermediate- and long-term effects of treatment on patients with cancer and on their caregivers.

PURPOSE: This clinical trial is studying quality of life of older patients who are undergoing treatment for cancer and of their family caregivers.

OBJECTIVES:

* Obtain quality of life and psychosocial data from older patients who are undergoing treatment for cancer and from their family caregivers.

OUTLINE: This is a pilot, cross-sectional study.

Patients undergo a 45-minute interview in person or by phone to provide demographic data and to complete quality of life questionnaires, including Functional Assessment of Cancer Therapy (FACT), Spiritual tool, Quality and Satisfaction with Treatment (QUEST), and Profile of Mood State (POMS), at baseline and at 3 and 12 months. Caregivers undergo a 20- to 30-minute interview in person or by phone to provide demographic data and complete quality of life questionnaires, including the Caregiver Reaction Assessment (CRA), Quest, and POMS, at baseline and at 3 and 12 months. Caregivers complete the Quality of Death and Dying (QODD) questionnaire 2-3 months after the patient's death.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patient:

  * Confirmed diagnosis of any type of cancer
  * Undergoing cancer treatment at Ireland Cancer Center
* Caregiver:

  * Identified family caregiver of a patient diagnosed with cancer
* Patient and caregiver may participate regardless of whether the other person agrees to participate or not

PATIENT CHARACTERISTICS:

Performance status

* ECOG 0-3 (patient)

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Able to speak and comprehend English
* Cognitively competent to be interviewed (patient)

PRIOR CONCURRENT THERAPY: Not specified
N-of-few Study of Pain Perception

A behavioral study that will examine how pain perception is affected by different types of conditioning and by context, with a few participants and multiple sessions ("N-of-few" design).


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants

Exclusion Criteria:

* Cannot tolerate heat pain applied to the forearm/leg, based on a calibration task at the beginning of the experiment
Transcranial Magnetic Stimulation in Alcohol Use Disorder

Repetitive Transcranial Magnetic Stimulation (rTMS) of the dorsolateral prefrontal cortex may affect neuro-adaptations associated with alcohol use disorder (AUD), potentially influencing craving and alcohol intake.

Investigators investigated alcohol intake and dopamine transporter (DAT) availability by Single Photon Emission Computed Tomography (SPECT) in the striatum of AUD patients before and after deep rTMS.

The study included AUD patients. Patients were enrolled by the alcohol addiction unit of the Internal Medicine, Gastroenterology and Hepatology Department of the Catholic University in Rome, Italy, according to the inclusion criteria. Screening collection of medical history, physical, neurological and psychiatric examinations as well as laboratory tests were performed. Moreover, patients were underwent to baseline SPECT assessment of striatal DAT availability using 123I-N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-iodophenyl) nortropane (123I-FP-CIT) as the radiotracer. Subsequently, patients were randomized in two groups (matched for gender and age) by a computer program for the REAL deep rTMS or SHAM. After weekly sessions of deep rTMS for four weeks, patients were underwent to the same clinical assessment as in the screening phase and second SPECT .

Moreover, the alcohol intake during both the four weeks prior to the enrollment and the 4 weeks of rTMS sessions were assessed through the Timeline Followback (TLFB) interview, an instrument providing a retrospective estimation of the number of drinks per drinking days, the number of drinking days, the number of abstinence days, the number of heavy drinking days and the total number of drinks. Patients were also evaluated with Alcohol Dependence Scale (ADS), Obsessive Compulsive Drinking Scale (OCDS), State-Trait Anxiety Inventory Scale (STAI Y1 and STAI Y2),Zung Self-Rating Depression Scale.

Eligibility Criteria:
Inclusion Criteria:

* At least two days a week of excessive alcohol consumption during the month prior to screening;
* Ability to provide informed consent;
* A Clinical Institute of Withdrawal Assessment in Alcohol Withdrawal score \< 10;
* Willingness to abstain from or substantially reduce alcohol consumption;
* Permanent residence.

Exclusion Criteria:

* Clinically significant psychiatric diseases;
* Past or current abuse or dependence on substances other than alcohol or nicotine;
* Neurological disorders;
* Unstable medical conditions;
* Pacemakers, implanted metallic pumps, metal implant;
* History of complicated withdrawal symptoms;
* Current use of psychoactive drugs;
* Epilepsy;
* Current use of anticonvulsants, insulin or oral hypoglycemic agents;
* Positive urine toxicological screening;
* Pregnancy;
* Participation in other clinical trial in the last 60 days;
* Involvement in a compulsory medical treatment or pending criminal proceedings.
Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis

In this pilot study, we wish to evaluate the performance of a robotic flexible ureteorscopy (ILY) in the treatment of nephrolithiasis in the superior excretory system


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* The patient has a single kidney stone in the calyx or the pelvis between 5 and 15mm something to do with a JJ probe
* Patient has an indication for in situ lithotripsy by supply ureteroscopy

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The patient is under safeguard of justice or state guardianship
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is pregnant or breastfeeding
* Patient treated with anticoagulants
* Documented untreated urinary infection within the previous 48 hours
Fractional CO2 Laser Assisted Photodynamic Therapy

Nodular Basal Cell Carcinomas:

Compare the efficacy and safety of conventional versus fractional laser assisted PDT for difficult to treat nodular cell carcinomas in the face.

Actinic keratosis:

Compare the efficacy and safety of conventional versus fractional laser assisted PDT for moderate to severe actinic keratoses located in the face and on the hands.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Skin type I-III
* Fertile women using secure birth control
* Moderate to severe actinic keratoses in the face or on the hands,
* Difficult to treat nodular basal cell carcinomas in the face

Exclusion Criteria:

* Pregnancy or breast feeding patients
* Patients with porphyria
* Patients with Gorlins syndrome
* Patients with a tendency to produce hypertrophic scars or keloids
* Patients with known allergy to Metvix
* Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic, dementia, mentally ill etc.)
* Patients with pigmented or morphea basal cell carcinomas
* Know herpes simplex virus infection in treatment areas
Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)

Aortic Stenosis is a common but fatal disease when it becomes symptomatic, specially if not treated. Until now surgery remains the only reliable and effective treatment.

In this study, the investigators will examine the effect of high dose of Menaquinone-7 (MK-7) supplementation (1000 mcg)/day on the progression of the aortic valve disease. The investigators hypothesize that MK-7 supplementation may slow or even reverse the progression of the disease process.

The study is a randomized clinical trial that will use Cardiac Echography and multi-detector computed tomography to compare the changes in the Aortic Valve Calcification Score (AVCS) over 3 years when using:

1. 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3
2. 5000 IU/d Vitamin D3 as a control group

Eligibility Criteria:
Inclusion Criteria:

* AVCS \> 300 without aortic valve stenosis requiring operation
* Focus on patients with:

  1. Bicuspid aortic valve
  2. Dialysis or CKD
  3. Statin treatment

Exclusion Criteria:

* Use of Vitamin K antagonist
* Malabsorption Problem
* LVEF \< 40%
* A life expectancy \< 3 years
Nutritional Support During Antiviral Therapy for Hepatitis C

Standard antiviral treatment consists of weekly injections with Peginterferon-α in combination with ribavirin. This treatment may lead to significant weight loss (7% within 24 weeks on average), with decreased quality of life. In this study the investigators will examine in 50 patients whether nutritional advise and support can prevent weight loss during antiviral therapy.

Standard antiviral treatment consists of weekly injections with Peginterferon-α in combination with ribavirin. This therapy, however, leads to weight loss of approximately 7% in the first 24 weeks of therapy possibly related to impaired postprandial gastric emptying. Such rapid weight loss is a marker of deterioration of the nutritional status with increased risk of complications and reduced immunological barrier function. Deterioration of the nutritional status also exacerbates side effects of the antiviral treatment like fatigue and depression. As a result, the quality of life of these patients may decrease. In the current controlled, prospective, multicenter, study we primarily aim to compare the effects of preventative versus on demand nutritional advice in combination with nutritional support on reduction of weight loss in patients receiving standard antiviral therapy with PEG-interferon in combination with ribavirin. We will randomize patients for the preventative intervention with dietary consultation combined with dietary supplementation of a daily snack or the on demand dietary support group (only dietary follow up, no dietary advice or snack, standard care). In the on demand group, patients will be referred to the dietitian in case of weight loss of ≥ 5% or a BMI \< 20 during antiviral therapy. Assuming that 60% reduction of weight loss during the first 24 weeks of treatment is clinically relevant, 2 x 25 patients need to be included (α=0.05, β=0.2: power=0.8 and a drop-out rate of 15%). Primary aim is to assess whether the intervention can decrease the amount of weight loss during therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hepatitis C
* Indication for antiviral therapy
* Age \> 18 years
* Good understanding of Dutch or English language
* Informed consent

Exclusion Criteria:

* Co-infection with hepatitis B and/or HIV
* Significant non hepatic diseases
* Significant previous surgery of the gastro-intestinal tract
* Hepatocellular carcinoma or other current malignant disease
* BMI \< 20