cyrilzakka/clinical-trials huggingface dataset:
Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial

Currently no consensus exists on the optimal way to manage asymptomatic patients with celiac disease (CD) and Type 1 diabetes (T1D). The impact of dietary treatment as it pertains to clinically relevant outcomes such as metabolic control, bone mineralization and wellbeing will be evaluated in this study. A randomized controlled study longitudinally evaluating HbA1c and glycemic excursions using continuous glucose monitoring will rigorously determine the impact of a gluten-free diet (GFD) on blood glucose variability in patients with T1D.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet each of the following criteria for inclusion into the study:

1. Males and females age between 8 and 45 years.
2. Diagnosis of T1D by American Diabetes Association (ADA) criteria with duration of T1D greater than 1 year.
3. CD screen positive (Positive TTG serology).
4. Presence of a positive duodenal biopsy for CD (Marsh score of 2 or greater).
5. Ability of the subject or a legally authorized representative to speak and read English or French.
6. Ability of the subject to participate in all aspects of this clinical trial.
7. Written informed consent must be obtained and documented, with assent of the child if \<14 years of age.

Exclusion Criteria:

1. Prior diagnosis of CD.
2. Symptoms or other evidence of overt CD defined by at least one of:

   * CD symptoms using the Gastrointestinal Symptom Scale \[GISS\]
   * Impaired growth
   * Anemia
3. Presence of recurrent apthous ulcers (painful mouth ulcers involving mucous membranes) or dermatitis herpetiformis (blistering skin rash). Mouth or skin lesions known to be related to diagnosed herpes are not included in this exclusion criteria.
4. Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
5. Prior enrolment in the current study.
6. Concurrent enrolment in a longitudinal intervention study.
7. Previously diagnosed or treated osteoporosis.
8. Pregnancy or lactation.
Proton Radiation for Resectable Carcinoma of the Pancreas

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will look at the side effects from the treatment and the quality of your life in relation to pain. It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.

Chemotherapy capecitabine on radiation days

Proton radiation over 6 weeks

Surgery 6 weeks after radiation completion

Adjuvant Chemotherapy starting 2-8 weeks after surgery with Gemzar

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of the pancreas.
* Patients must have marginally resectable disease.
* Patients with biliary obstruction must have adequate drainage prior to starting chemoradiation.

Exclusion Criteria:

* Evidence of distant metastasis including peritoneal seeding and/or ascites.
* Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
* Prior surgical resection.
* Gastroduodenal obstruction
Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones

Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for pancreatic duct stones is a amjor problem, especially bigger size stones. After ERCP failure, surgery was the only option but patients not suitable for surgery were treated through stenting. But had to undergo multiple ERCPs and show lower success rate. Recently, SpyGlass and extracorporeal shock wave lithotripsy (ESWL) have been applied for the treatment of huge stones. The present study aims to compare the efficacy and safety outcomes of SpyGlass-guided lithotripsy and ESWL procedures for the removal of pancreatic duct stones.

ESWL was first used for the removal of renal calculi and ureteral calculi however, now a day is being used for pancreatic duct stones and biliary calculi. It has the advantages of simple operation, lower cost, and higher safety. Recent studies show that the procedure time for ESWL is also shorter and the utilization rate of mechanical lithotripsy was effectively reduced with fewer complications. But It is difficult for ESWL to break the stones larger than 3cm into small pieces.

Spyglass has been used in clinics for more than ten years. Recently, a study reported difficult bile duct stones that were treated with SpyGlass-guided laser lithotripsy that shows promising results. Compared with laser lithotripsy under X-ray monitoring, there is no significant difference in stone removal rate and complication rate between the two methods. However, the effect of lithotripsy under Spyglass direct vision is better, which can break large stones into smaller pieces, thus making it easier to take stones. Investigator conducted the current study to compare the therapeutic outcome and complications between SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large pancreatic duct stones.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic duct sone
* Falied to eliminate through ERCP only

Exclusion Criteria:

* Pregnancy
* Refusal of written informed consent
* Patients not suitable for ESWL/ Spyglass
* Contraindications to ERCP exist
* Complicated with acute pancreatitis or acute cholangitis
* Coagulation dysfunction#thrombocytopenia
* Patients after gastrointestinal reconstruction
* Allergic to drugs
French Adaptation of the AIDA (Assessment of Identity Development in Adolescence) and LoPF-Q (Levels of Personality Functioning Questionnaire) Scales.

The main objective of this study is to develop the French version of the two questionnaires AIDA and LoPF-Q. The secondary objective is to investigate the links between disrupted development of identity and adolescent psychopathology.

To participate in the study, patients will have to complete online or paper versions of the questionnaires AIDA-LoPF and other assessments of personality and general psychopathology (BB5, SDQ). Parents will have to answer complete the parent version of the SDQ questionnaire. The BPFSC-11, which is a clinician-rated assessment, will be completed in a subgroup of patients, by the same healthcare professional, in order to assess the concurrent validity. The investigators will also add the clinical diagnoses according to ICD-10 found in the medical record.

A personality disorder is a lasting mode of behavior and lived experience that deviates significantly from what is expected in the culture of the individual is invasive and rigid, appears in early adolescence or adulthood, is stable over time and is a source of distress or impaired functioning.

Most of the tools for assessing high-risk personality disorders and traits have been developed in adults.Yet it is important to have effective tools to distinguish personality disorders from other mental disorders as early as possible. The identification of young people at high risk of personality disorders allows their rapid referral to appropriate psychotherapies.

The AIDA and LoPF-Q, screening questionnaires, were recently developed to include an assessment of personality functioning in the process of diagnosing emotional and behavioral disorders in adolescence. They have been tested in several countries such as Germany, USA, Mexico, Croatia... The results of the studies show that AIDA and LoPF questionnaires are reliable and valid instruments for assessing normal and disturbed identity in adolescents and distinguishes well between patients with psychiatric illnesses and healthy controls.

Eligibility Criteria:
Inclusion criteria:

* The adolescent must be between 12 and 18 years old
* be able (see non-inclusion criteria below) and agree to complete the various evaluations proposed, and not present a psychotic episode at the time. time of the questionnaires.
* The adolescent does not have to have any risky personality traits to participate in this study.

Exclusion criteria:

* insufficient levels of French and / or reading
* presence of an intellectual development disorder or a clinically proven current psychotic disorder,
* active or passive opposition of the patient and / or its legal representatives to participate in the study.
Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)

The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an arteriovenous graft (AVG). Data from this study will be used to aid dose selection of MK-2060 in future studies. The primary hypothesis is that at least one of the MK-2060 doses is superior to placebo in increasing the time to first occurrence of AVG event.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of ESRD.
* Receiving hemodialysis (including hemodiafiltration) ≥3 times per week for a minimum of 3 hours per session via a mature normally functioning, uninfected AVG with at least 75% of the sessions meeting these criteria over the 4 weeks prior to randomization.
* A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 90 days after the last dose of study intervention.

Exclusion Criteria:

* Recent history of cancer (\<1 year). Non-melanoma skin cancers are allowed.
* Mechanical/prosthetic heart valve.
* Recent hemorrhagic stroke or lacunar stroke (\<1 month).
* Recent evidence (\<1 month) of bleeding requiring hospitalization or unplanned medical attention, a history (≤2 years) of recurrent bleeding episodes including epistaxis, gastrointestinal (GI) bleeds or genitourinary (GU) bleeds requiring medical treatment or events requiring treatment with blood products.
* Recent history (\<1 year) of drug or alcohol abuse or dependence.
* Currently receiving or planning to receive anticoagulants or antiplatelet medications (intradialytic heparin and aspirin are permitted).
* Planning on receiving a living donor renal transplant within 12 months (participants are permitted to be candidates for deceased donor renal transplants).
* Planning on receiving an arteriovenous fistula (AVF) placement within 12 months.
Far Infrared Radiation Treatment for Diabetes

A study to determine the use of far infrared (FIR) radiation for treatment of diabetes.

Diabetes mellitus is a disease in which glucose is not sufficiently metabolized. This results in high glucose levels in blood and glucose in the urine. Cells can starve because glucose is not being metabolized.

Both types of diabetes can cause dangerous complications, including blindness, heart and blood vessel disease, and kidney failure. A decrease in circulation may eventually require the amputation of limbs.

We are postulating that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby improving the health of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Persons with type 1 or type 2 diabetes

Exclusion Criteria:

* None
Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple Sclerosis

This study was carried out to investigate the relationship between pain, anxiety and fatigue and knee position sense, balance and dual task performance during menstrual cycle in females with Multiple Sclerosis (FwMS).

In the neurologic group, especially in MS patients, it is well known that disease activity, course, and symptoms can be influenced by the menstrual cycle. Previous studies have reported that the fluctuations of estrogen and progesterone during the menstrual cycle may have an effect on several neurological functions. Menstrual-related symptomatology has primarily been studied as a physiological phenomenon. Increased neurological symptoms, physical disorders and behavioral changes have been reported just before or at the beginning of menstruation in FwMS.

For all these reasons,investigators think that relationship between pain, anxiety and fatigue and knee position sense, balance and dual task performance during menstrual cycle in FwMS.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria were as follows: patients with a confirmed diagnosis of MS according to the McDonald criteria, physician-administered Expanded Disability Status Scale (EDSS) range of 1-3.5, having regular menstrual cycle (between 21-35 days), and cognitive levels to give history and following the instructions.

Exclusion Criteria:

The exclusion criteria were: patients with acute attacks and using corticosteroid (three months prior to the study), taking oral contraceptive agents, and history of orthopedic lower extremity problems or other neurological disorders.
Immunoparalysis in Acute Kidney Injury After Cardiac Surgery

Infection and sepsis are common after acute kidney injury (AKI) and increase mortality. In this study, the investigators will determine whether patients with acute kidney injury after cardiac surgery have immunosuppression as judged by blood markers of immunoparalysis.

Immunoparalysis is an immunosuppressed state that occurs after a wide variety of insults including sepsis and cardiopulmonary bypass surgery. Due to the impaired infection fighting ability, patients with immunoparalysis are at risk of subsequent infection which can increase mortality. Immunoparalysis can be measured by two methods: 1) ex vivo endotoxin stimulation and 2) blood monocyte HLA-DR levels. Since sepsis is also a known complication of Acute Kidney Injury(AKI), the investigators hypothesize that AKI is a risk factor for immunoparalysis. The investigators plan to look at these blood factors of immune function from patients before and 3 days following cardiac surgery. Urine will also be collected from the patients before their surgery as well as the 3 days following for AKI biomarker measurement. This prospective cohort will enroll 300 patients and determine the duration and severity of immunoparalysis among patients who develop AKI and those who do not develop AKI.

Eligibility Criteria:
Inclusion Criteria:

* All adults undergoing cardiac surgery with CPB will be considered for enrollment.

Exclusion Criteria:

* Factors that affect immune function or AKI assessment are the basis for exclusion criteria:

  * Concurrent disease associated with immunosuppression including malignancy, chronic infection (e.g., HIV, Hepatitis C), organ transplant and immunosuppressant medications
  * Documented acute infection with the past 1 month (e.g., pneumonia, urinary tract infection)
  * Prednisone or other steroid use currently or within the past one month
  * AKI at the time of surgery
  * ESRD requiring renal replacement therapy
  * Estimated GFR \<45 mL/min (as judged by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy

This study aims to assess brain death and deep coma with the self-made near infrared spectroscopy (NIRS) instrument. The investigators used the noninvasive method to monitor the Δ\[HbO2\] (the concentration changes in oxy-hemoglobin) and Δ\[Hb\] (the concentration changes in deoxy-hemoglobin) in the region around the forehead of medically evaluated participating patients and healthy subjects. A multiple-phase protocol at varied fraction of inspired O2 were utilized during the assessment.

Brain death is an irreversible loss of all brain functions, while deep coma is a profound state of unconsciousness associated with depressed cerebral activity. Timely distinguishing the two states is crucial for saving patients. The noninvasive, sensitive, universally available, and timely ancillary method to assess brain death and deep coma has not been established. This study aims to explore a noninvasive and straightforward way in brain death and deep coma online assessment. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy instrument attached on the forehead of participators. A multiple-phase protocol at varied fraction of inspired O2(FIO2) were utilized during the assessment. Then the investigators compared the multiple physiological parameters changes among different groups at different FIO2.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had brain death or serious brain trauma.
* Patients who have deep coma with autonomous respiration according to GCS coma Scale
* Healthy people who are interested in optical assessment of hemodynamic parameters

Exclusion Criteria:

* Patients who are in pregnancy or have plan to conception.
* Patients who have vertebra surgery or have plan of surgery.
* Patients who are inappropriate to join this trial judged by the radiologists or specialists.
* AIDS, Active Hepatitis, Tuberculosis, Syphilis
* Patients who regularly take anticoagulants, antiplatelet drugs
PULSAR Combined With PD-1 Ab and Chemotherapy Plus Bev. for CRLM

To explore Progression-Free-Survival(FPS) of PULSAR(personalized ultrafractionated stereotactic adaptive radiotherapy) combined with PD-1 Ab and Chemotherapy plus Bevacizumabfor CRLM


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years, any gender.
2. Pathologically confirmed colorectal cancer with liver metastases (stage M1).
3. Karnofsky Performance Status ≥70.
4. Adequate organ function, no contraindications to radiotherapy, or immunotherapy.
5. Microsatellite/mismatch repair status MSS/pMMR.
6. No prior chemotherapy or any other anti-tumor treatment before inclusion.
7. No prior immunotherapy.
8. Ability to comply with the study protocol during the study period.
9. Signed written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Pathological diagnosis of signet ring cell carcinoma.
3. History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
4. Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
5. Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
6. Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
7. Patients with autoimmune diseases.
8. Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
9. Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L.
10. Known deficiency of dihydropyrimidine dehydrogenase (DPD).
11. Allergy to any investigational drug components.
School- and Home-Based Early Intervention for Toddlers With Autism

This study will determine the impact of early intervention on the communication and social development of toddlers with autism.

Autism is a condition that affects brain development, often leading to difficulties in social, emotional, and educational functioning. This study will determine whether early intervention can improve such functioning in toddlers with autism.

Each treatment session will last 6 months. Children with an autism spectrum disorder will be enrolled in one of two parallel classes and will receive one of two treatments 4 days a week for the duration of the session. Children in each class will receive the same amount and level of intervention, but with a different goal focus. Treatments will be school- and home-based; parents will receive instruction on administering the at-home part of the treatment. The intervention will include environmental engineering, developmental approaches, adaptations of traditional behavioral approaches, and contemporary behavioral approaches that apply principles of applied behavior analysis in more naturalistic teaching frameworks. A series of measures including scales, interviews, and observations will be used to assess the children at baseline, study completion, and 6 months after study completion. The children will be videotaped during the school-based intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism spectrum disorder
* Parent or guardian willing to give informed consent for child's participation
* Developmental level above 9 months on the Visual Reception Scale of the Mullen Scales of Early Learning and on the Adaptive Behavior Composite of the Vineland Adaptive Behavior Scales
* English is primary language for child and family

Exclusion Criteria:

* Evidence of vision or hearing impairment
* Diagnosis of fragile X syndrome, Rett syndrome, tuberous sclerosis, neurofibromatosis, phenylketonuria, or congenital rubella
* History of severe birth trauma or traumatic brain injury
* Siblings with autism spectrum disorder
Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease

Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.

Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. At this age, comorbidities are frequent and numerous, and often linked to pain. The prevalence is comprised between 40 and 85% according to different studies. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.

The primary outcome is to evaluate the singing support on physical pain, by comparison with a control activity : "painting session".

Eligibility Criteria:
Inclusion Criteria:

* Patients 60 years old and older, fulfilling the diagnostic criteria for Alzheimer's disease to a mild dementia stage, or mild cognitive impairment
* Delay of at least one month between the diagnosis and the early work sessions
* If use of psychotropic drugs, they must be stabilized for 3 month
* If analgesics consumption level 2 or 3 they must be stabilized for 1 month
* With a score greater than or equal to 22 on the simplified visual scale (EVS) pain.
* Visual capabilities , auditory and oral or written expression in French language sufficient for conducting clinical and neuropsychological evaluations;
* MMSE \> 20
* Patient affiliated or entitled to a social security scheme

Exclusion Criteria:

* Patient with a different etiology of cognitive disorder that of Alzheimer's disease
* Patients with severe disease, progressive or unstable nature which may interfere with the evaluation variables
* Patient with blindness or deafness could compromise its assessment
* Patient under guardianship