cyrilzakka/clinical-trials huggingface dataset:
The Effect of Gluten on Gut Microbiome and Metabolic Health.

Objective: To identify how specific changes of the gluten content in the diet affect the host-gut microbiome interactions with implications for metabolic health.

Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included.

Intervention: low vs high gluten intake.

The study is designed as a randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included. Participants consume, in randomized order, a gluten-poor diet (\<5 g/d) in the active treatment period and a gluten-rich diet (\>25 g/d) during the control period.

Measurements: Altered quantitative metagenomics at bacterial gene- and species levels is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, circulating appetite hormone levels,serum metabolomics, gastrointestinal transit time and intestinal permeability. Furthermore, selected control measures are included; 4-day food records and a study intervention dietary records.

Eligibility Criteria:
Inclusion Criteria, compulsory:

* Body mass index (BMI): 25 - 35 kg/m2 OR
* Abdominal obesity: waist circumference: men: ≥ 94cm; women: ≥ 80cm
* No medically prescribed diet
* Weight stable
* Intense sporting activities less than 10 h/week
* Alcohol consumption less than 14 units/week (female) and 21 units/week (male)
* Signed informed consent

Inclusion criteria, minimum one of the following:

* Fasting plasma glucose from 6.1 mmol/l to 6.9 mmol/l
* Reduced high density lipoprotein (HDL) cholesterol; HDL ≤ 1.03 mmol/L for men and ≤ 1.29 mmol/L for women
* Increased triglyceride (TG) \> 1.3 mmol/L
* Systolic blood pressure \> 130 mmHg

Exclusion Criteria:

* Pharmacological treatment; diabetes and blood lipid regulation
* Lactating (or lactating, 6 weeks ago), pregnant (or pregnant, 3 months ago) or wish to become pregnant during the study
* Participation in another biomedical trial 1 month prior to study start
* Diagnosed with any form of diabetes, celiac disease or chronic pancreatitis
* Reported chronic gastrointestinal disorders
* Antibiotic treatment for 3 month prior to study start
* Blood hemoglobin \< 7.0 mmol/l
* Blood donation within 1 month prior to study start
Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan

This study is a prospective, multicenter, real-world study. There are four cohorts. Cohorts 1-3 include second-line, posterior-line, and neoadjuvant colorectal cancer patients, respectively. Cohort 4 include patients with the exception of those with pancreatic and colorectal cancer. As this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. Through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.


Eligibility Criteria:
Inclusion Criteria:

1. Cohort 1:

   * Patients with histologically or cytopathologically confirmed colorectal adenocarcinoma who were diagnosed with unresectable metastatic disease.
   * Known to be pMMR/MSS or MMR/MS status unknown.
   * Prior first-line systemic oxaliplatin - and fluorouracils-based therapy for metastatic disease progressed.
   * Patients had not received IRI or Nal-IRI during the treatment phase of metastatic disease.
   * Patients were scheduled to receive Nal-IRI plus fluorouracils or IRI plus fluorouracils chemotherapy regimens as second-line systemic therapy.
2. Cohort 2:

   * Patients with histologically or cytopathologically confirmed colorectal adenocarcinoma who were diagnosed with unresectable metastatic disease;
   * Known to be pMMR/MSS or MMR/MS status unknown.
   * Patients had received ≤ 3 lines of previous treatment for metastatic disease.
   * Progression of metastatic disease after treatment with an IRI-containing regimen (no limit on the number of IRI treatment lines).
   * The patient had not previously received Nal-IRI and was scheduled to receive a systemic Nal-IRI containing chemotherapy regimen as palliative treatment.
   * Have at least one measurable lesion according to RECIST v1.1.
3. Cohort 3:

   * High-risk (CRS score 3-5) synchronous liver metastatic colorectal adenocarcinoma with ≤5 liver metastases, confirmed by histopathology or cytopathology, and planned resection.
   * Known to be pMMR/MSS or MMR/MS status unknown.
   * The patient was scheduled to receive Nal-IRI+ oxaliplatin + fluorouracils chemotherapy regimen as neoadjuvant therapy.
4. Cohort 4:

   * Non pancreatic cancer and non colorectal cancer patients confirmed by histopathology and/or cytology.
   * Have received at least one systemic treatment for unresectable diseases;
   * Plan to receive a systemic treatment regimen containing Nal IRI;
   * At least one measurable lesion (according to RECIST v1.1);

Exclusion Criteria:

Cohort 1-4:

* Treatment with an immune checkpoint inhibitor (e.g., pembrolizumab, nivolumab) was planned during chemotherapy.
* Allergy to irinotecan or liposomal irinotecan and its excipients is known.
* Female patients known to be pregnant or lactating.
* Other patients who were deemed by the investigator to be ineligible for enrollment.
Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast

The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination

CadAI-B for Breast is a real-time AI diagnosis system designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. The primary objective of the study is to evaluate the effectiveness of CadAI-B in the assistance of detection and diagnosis of breast cancer by comparing the clinical performance of physicians before and after using CadAI-B in their ultrasound reading. The secondary objective of this study is to evaluate the sensitivity and specificity using CadAI-B for US examinations.

Eligibility Criteria:
Inclusion Criteria:

* Women who underwent breast US examination
* Women with breast cancer (DCIS or invasive cancer) diagnosed via biopsy
* Women who had been followed for more than 2 years after initial US examination

Exclusion Criteria:

* women who had breast implants
* women who had US images containing artifacts affecting the review of images
Defining the 'Sniffing Position" in Infants and Toddlers - A Pilot Study

The "sniffing position" is widely accepted as a favorable position for direct laryngoscopy (DL) in both pediatric and adult patients. External anatomical markers are well documented to confirm proper 'sniffing position' in adults, but data on their use in the pediatric population is sparse. The investigators propose to define these markers in young children and investigate whether patients positioned using this standardized approach have better intubating conditions than those positioned randomly per the preference of the anesthesiologist.

The procedure of endotracheal intubation in adults and children is a continuum, and begins with proper head positioning prior to direct laryngoscopy (DL). It is an accepted paradigm that proper positioning optimizes intubating conditions, and decreases subsequent airway maneuvers and manipulation.

The sniffing position is an accepted airway positioning concept in pediatric airway management, and continues to be recommended by experts and textbooks in the field. Anatomical peculiarities such as the large head relative to the torso in infants and toddlers is assumed to put the head in proper position when gently extended. However, reproducible parameters to confirm optimal head positioning remain vague and unclear. In the absence of objective and measurable markers, practitioners position infants and toddlers according to their individual preferences, and as such the procedure lacks definition and objective clarity.

The investigators plan to recruit 40 healthy patients between the ages of 1 month - 48 months and randomize them to be positioned either according to a predetermined algorithm or positioned freely according to the provider's preference. Patients randomized to the intervention group will be positioned with the aim to horizontally align the external auditory meatus (EAM) with the sternal notch (SN).

In summary, the study aims to define the sniffing position for infants and toddlers using reproducible objective secondary markers, and investigate whether a systematic approach to positioning using such markers improves direct laryngoscopic outcomes in the young pediatric patient population.

Eligibility Criteria:
Inclusion Criteria:

* healthy infants and toddlers undergoing non-emergent surgery under general anesthesia with an oral endotracheal tube

Exclusion Criteria:

* neonates (infants under 1 month of age), infants and toddlers with congenital syndromes affecting the airway, and patients undergoing emergency surgery.
The Use of Cyproheptadine in Pediatric Feeding Disorders

The goal of this clinical trial is to learn if Cyproheptadine, an appetite stimulant, can improve eating habits in children with Pediatric Feeding Disorders. Pediatric Feeding Disorders is a broad term that describes disorders of eating-related behaviors that causes altered consumption of food and impairs physical or psychosocial health.


Eligibility Criteria:
Inclusion Criteria:

* Any patient aged 2-6 years of age who presents to Pediatric Gastroenterology Clinic with complaint of "poor weight gain, malnutrition, failure to thrive/weight faltering, picky eating, or feeding issues" who screens positive for a pediatric feeding disorder using the Child eating disorder questionnaire (CEBQ)
* Age Range: 2-6 years
* English or Spanish speaking

Exclusion Criteria:

* Patients who are tube fed
* Patients who are overweight (BMI at 85th%tile or greater)
* Patients who have active symptoms from a diagnosis of a GI disorder (Inflammatory Bowel Disease, Eosinophilic Esophagitis, Gastritis)
* Patients actively undergoing behavioral feeding therapy
A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain

The purpose of this study was to determine the immediate effect of 3 common physical therapy interventions for people experiencing low back pain on the perception of thermal pain. Additionally, the investigators wished to determine the influence of psychological factors related to fear and anxiety on their findings and to determine whether the effects of the individual interventions were local (specific to the area of application) or global (influenced regions away from the area of application).


Eligibility Criteria:
Inclusion Criteria:

* ages eighteen to sixty
* currently experiencing low back pain OR currently not experiencing low back pain and have not had an episode for the prior six months

Exclusion Criteria:

* non-English speaking
* systemic medical conditions (e.g. diabetes, hypertension)
* current use of psychiatric medication
* pregnancy
* signs and symptoms indicative of nerve root compression (reflex change, myotomal weakness, or sensation change)
* history of surgery to the low back
Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.

The BEET IT study investigates the possible protective effect of beetroot juice on POI following colorectal surgery in (partially) blinded single-center phase 2 randomized trial (pilot study).

Postoperative ileus (POI) is a transient impairment of gastrointestinal motility following abdominal surgery, which leads to increased morbidity, prolonged hospitalization and increased healthcare cost. The pathogenesis of POI involves inflammation and oxidative stress, similar to ischemia/reperfusion injury that can be counteracted with beetroot juice. Beetroot juice is a source of inorganic nitrate, which by conversion of nitrate to nitrite in the body, exerts its protective effect. We before demonstrated in a preclinical model that administration of exogenous nitrite was shown to protect against POI. The aim of this pilot study is to investigate the possible protective effect of beetroot juice ingestion on POI following colorectal surgery.

Eligibility Criteria:
Inclusion Criteria:

• All patients undergoing colonic or upper rectum laparoscopic surgery.

Exclusion Criteria:

* Pregnancy or breast feeding
* Psychiatric pathology capable of affecting comprehension and judgment faculty
* History of metastatic disease
* History of prior abdominal bowel surgery
* Abdominal radiation treatment
* Chronic constipation (defined as two or fewer bowel movements per week)
* Gut motility influencing agents (e.g. tricyclic antidepressants, chronic use of laxatives)
* Frequent use of mouthwash, as this affects the enterosalivary circulation of nitrate
* Current use of broad-spectrum antibiotics, which will affect the oral flora and likely affect the nitrate reductase activity
* More than one bowel anastomosis during this surgery
Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker

It is a translational research study with mechanistical objectives and including biological samples of patients with thrombocytopenia

This study is a prospective study to collect blood, bone marrow and hair bulb from patients with thrombocytopenia, to better understand the mechanism of idiopathic chronic thrombocytopenia of undetermined significance (ICTUS)

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80
* Nosological criteria for thrombocytopenic patients:
* ICTUS: acquired thrombocytopenia lasting\>6 months, without feature of dysimmunity (antiplatelet Ab, or anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), normal bone marrow examination, absence of other thrombocytopenia in the family. All ICTUS patients included in the study will thus have a bone marrow aspiration.
* ITP: Diagnosis of ITP is made according to the international ITP consensus (diagnostic criteria of Rodeghiero){Provan, 2010 #18}, knowing that a presumptive diagnosis of ITP is made when the history, physical examination, complete blood count, and examination of the peripheral blood smears do not suggest other etiologies for the thrombocytopenia. There is no "gold standard" test that can reliably establish the diagnosis. We are concerned that this group of patients may include ICTUS patients.
* ITP with immunological features: ITP with detectable anti-platelet antibodies (Ab) and/or autoimmunity (anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), and/or previously responsive to immunomodulatory ITP-directed therapies (steroids, intravenous Immunoglobulin, rituximab, splenectomy). We will use these patients as non-ICTUS, ITP positive controls.
* Thrombocytopenic myelodysplasia: platelets \<150 G/l and diagnosis of myelodysplasia according to the WHO classification (abnormal bone marrow features).
* Healthy controls: patients with normal blood counts undergoing cardiovascular surgery for valve replacement, or healthy bone-marrow donors.
* Affiliated person or beneficiary of a social security scheme. Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Age under 18 or over 80
* Persons placed under judicial protection,
* Persons participating in another research including a period of exclusion still in course
* Persons in emergency situation,
* Pregnant or nursing women,
* Women of childbearing age who do not benefit from effective contraception (HAS criteria),
* Brain death or deceased persons,
* Person who doesn't speak French, doesn't read it, doesn't write it, and doesn't have a schooling in France.
Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia

Hypotension resulted from neuraxial block is a common problem, of which is a special issue in patients undergoing Cesarean section. A large number of studies and clinical guidelines suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing hypotension. However, it is still a controversy because the fact of a relatively increased blood volume in parturients. In addition, although it is effective of fluid management, it's precise relationship between fluid (crystalloid or colloid) volume and the proportion of hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The investigators designed this trial to clarify the accurate relationship between fluid volume in an escalated manner and the occurrence of hypotension analyzed with a non-linear regression, and wanted to present the 50% effective volume (EV50) of fluid including crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* 21-40 yr
* First time of delivery
* ASA status I-II
* No premature
* No genetic and infectious diseases
* Chinese

Exclusion Criteria:

* \< 21 yr
* \> 40 yr
* Subjects with cardiac and pulmonary disorders
* Dislocation of placenta
* Pregnant hypertension
* Allergy to local anesthetics
* Unwilling to cooperation
* Need intraoperative administration of vascular active agents
* With significant delivery side effects
* With contradictions of neuraxial anesthesia
Psychobiological Mechanisms of Placebo and Nocebo Effects in the Treatment of Chronic Back Pain

Placebo and nocebo responses have mainly been studied in healthy humans for pharmacological rather than psychological interventions. Moreover, only few studies examined patients or tested how previous experience and attitudes affect placebo and nocebo responses. On the psychological level expectancy and classical conditioning have been identified as two primary mechanisms. Both seem to be important with classical conditioning potentially having more long-term effects and expectancy being more important in nocebo effects. There is some initial evidence from the investigators own research that patients may be more prone to these effects and the investigators have also shown that placebo effects may last up to several years after treatment. The investigators therefore examine previous attitudes to pharmacological interventions for chronic pain in patients with chronic back pain and subdivide them into groups with high of low belief in the respective treatment modality. The investigators then apply a pharmacological placebo and study the interaction between the prevailing attitude (implicit and explicit) and the placebo effect with respect to pain perception but also to neurobiological mechanisms using functional magnetic resonance imaging. In addition to expectancy, conditioning of placebo will be examined and the long-term effects of the intervention will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Male and female human subjects with chronic back pain (chronic persistent and recurrent pain \> 6 months)
* Age between 18 and 65
* Voluntary participation.

Exclusion Criteria:

* Acute or chronic somatic diseases and inflammatory, neuropathic or tumor-related pain
* Acute and chronic mental disorders according to DSM-IV (except for comorbid anxiety or depression, which are frequent in chronic pain)
* Insufficient German language skills
* Cognitive limitations
* Intake of opioid medication or tranquilizers
* Metal implants or electric implants that cannot be removed
* Pregnancy
* Claustrophobia
* History of epilepsy, brain trauma, or brain tumor
Validation of Proteomic Analyses for Allergic Asthma and Rhinitis

The purpose of this study is to verify and validate the intrinsic diagnostic value in terms of sensitivity and specificity of proteomic profiles determined during a pre-study for discriminating between allergy related asthma and allergy related rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* signed consent
* never-smokers or non-smoking for at least 2 years + \< 5 packs per year
* capable of understanding the study
* patient is affiliated with a social security system
* positive skin tests (at least one for Montpellier region pneumoallergens)
* treated with nasal or inhaled corticoids, leucotriene receptor antagonists, anti-IgE, Theophylline, anti-histamines, sodium cromoglycate, beta-blockers, benzodiazépine, oral corticoids: all these treatments must be interrupted for at least 72 hours

Exclusion Criteria:

* Co-morbidities: none; no co-morbidities are accepted
* dental infections (any) during the 3 months preceding the study
* suspected alcoholism or drug abuse
* chronic viral infection (hepatitis, HIV)
* patient under guardianship
Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program

This Clinical Trial will evaluate the Feasibility and Acceptability of Oxygen Saturation Monitoring using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program


Eligibility Criteria:
Inclusion Criteria for Client Participants:

* Participants who are18 years of age or greater
* Participants housed within a supportive housing program who intend to inject opioids
* Participants who have given verbal informed consent to participate in the study

Inclusion Criteria for Staff Participants:

* Participant is research staff and/or Rita Thompson Residence staff
* Participant is willing to give implied consent by reading and completing the staff survey

Exclusion Criteria for Client Participants:

* Participants deemed not suitable for the study at the discretion of the principal investigator, research staff or housing program nurses/staff
* Participants with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, or other abnormalities that may interfere with MSNA functioning
* Participants with known allergic reactions to foam/rubber products and/or adhesive tape

Exclusion Criteria for Staff Participants:

-None
The Influence of Aerobic Endurance Training After Roux-en-Y-Gastric Bypass

The aim of this study was to assess the efficiency of aerobic physical exercise (APE) on weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y Gastric bypass (RYGBP).

The only effective treatment for patients with morbid obesity is bariatric surgery. Sudden weight loss following bariatric operations for morbid obesity, such as Roux-en-Y gastric bypass (RYGBP) can result in a concurrent decrease in lean body mass. However the long-time results (weight reduction, elimination co-morbidities) are depending on the post operative treatment. Aerobic physical exercising (APE) is well accepted in conservative treatment of obesity as well as of diabetes mellitus type 2 (DM). The aim of this study was to assess the efficiency of APE on weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y Gastric bypass (RYGBP).

Eligibility Criteria:
Inclusion Criteria:

* Obesity WHO III

Exclusion Criteria:

* Contraindications of aerobic endurance training