cyrilzakka/clinical-trials huggingface dataset:
First-in-man Trial of the Magnetic-controlled Balloon Inflation Mechanism of a Novel Ingestible Weightloss Microcapsule

The objective of this study is to demonstrate the ease of deployment of a novel magnetically-controlled ingestible weight loss microcapsule\* and the functionality of the magnetically controlled inflation of the balloon within the stomach.

The objective of this study is to demonstrate the ease of deployment of a novel magnetically-controlled ingestible weight loss microcapsule and the functionality of the magnetically controlled inflation of the balloon within the stomach. Device comes in the form of a gelatine coated pill (Ø9.6mm x 27mm) . Once in the stomach, the device may be driven by external magnetic controllers which can control both its position and orientation. It allows flexible approach of the external magnetic fields in any axial directions of the device, and it also controls the inflation valve which controls the inflation of an attached balloon. The inflated balloon will partially fill up the stomach, giving the subject the feel of satiety to reduce his/her desire to eat more food.

Eligibility Criteria:
Inclusion Criteria

* Healthy subject, as evidenced by medical history
* Male or female aged 21-50 years of age
* Willing to undergo endoscopy to retrieve the balloon and to comply with all study procedures
* Ability to provide a signed and dated informed consent form

Exclusion Criteria:

* Individuals with anatomical abnormalities or functional disorders that may inhibit swallowing or passage through to the stomach
* Individuals with history or symptoms of clinically significant esophageal or gastric disorders, peptic ulcerations, hiatal hernia, patulous pyloric channel, erosive esophagitis, varices, angiectasia, Barrett's esophagus
* Individuals with bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease
* Individuals with bleeding disorders
* Individuals already having other bioenteric devices placed
* Individuals who have pace makers, metal implants or other devices on them
* Pregnant women
* Individuals unable to make/sign informed consent
IVIg for Demyelination in Diabetes Mellitus

The purpose of this study is to determine whether intravenous immunoglobulin (IVIg) is an effective intervention for patients with diabetes, peripheral neuropathy, and demyelination on nerve conduction studies. All patients will receive both IVIg and placebo for 3 months each, with a 3 month washout period in between.

There is a knowledge gap with regards to the appropriate method of detecting and treating chronic inflammatory demyelinating polyneuropathy (CIDP), in patients with co-existent diabetes. In this pilot study the investigators plan to examine the overlap between diabetic polyneuropathy and CIDP by treating patients with diabetes and demyelinating abnormalities using IVIg. The investigators will enroll diabetes patients with a broad spectrum of demyelinating abnormalities.

The proposed trial will be an explanatory, blinded, single-centre, superiority, randomized controlled cross-over trial. Each patient will receive 3 months of 10% intravenous immunoglobulin and 3 months of placebo (0.9% sodium chloride in water) with a 3-month washout period. The primary outcome measure is the mean change in ONLS (Overall Neuropathy Limitation Scale), a measure of disability in polyneuropathy; however secondary outcome measures will consider impairments and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Diabetes, as per American Diabetes Association Criteria.
3. Clinical evidence of polyneuropathy and NCS shows 2 separate motor nerves (median, ulnar, tibial, or peroneal) which meet criteria for demyelination, defined as follows:

   1. Conduction velocity \<90% lower limit of normal (LLN), distal latency \>110% upper limit of normal (ULN), or minimal F-wave latency \>110% ULN
   2. The changes are not exclusively due to median neuropathy at the wrist, ulnar neuropathy at the elbow, or peroneal neuropathy at the fibular head.
4. Clinical suspicion of possible demyelinating polyneuropathy (CIDP).

Exclusion Criteria:

1. Pregnant patients, or those of childbearing potential not using contraception.
2. Patients \<18 years of age.
3. Presence of an alternative etiology of peripheral neuropathy, such as: hereditary neuropathies (Charcot Marie-Tooth disease); B-vitamin deficiency- or excess-related neuropathy; uremic neuropathy; neuropathy secondary to monoclonal gammopathy; history of cancer- or chemotherapy-related neuropathy; other toxin exposures; and alcoholic neuropathy.
4. Contraindication to IVIg, including: history of recurrent thrombosis, immunoglobulin A deficiency, or severe hypersensitivity reaction to IVIg in past, renal failure, recurrent deep venous thrombosis, pulmonary embolus, stroke, or myocardial infarction.
5. Presence of serious or unstable medical condition, which may preclude study completion or lead to inability to tolerate IVIg. This may include active heart failure, uncontrolled hypertension, or severe anemia, among other conditions.
6. Presence of concomitant neurological illness, which may confound evaluation.
7. Fails or unable to provide informed consent.
A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis

Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for 14 consecutive days.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a clinical diagnosis of stable plaque psoriasis
* Subject has an ODS score for the Treatment Area of 3 or 4 at study start

Exclusion Criteria:

* Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
* Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
* Subject has used any phototherapy, photo-chemotherapy or systemic corticosteroid therapy within 30 days prior to study start
* Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to study start
* Subject has used any systemic biologic therapy for the treatment of psoriasis within 5 half-lives of the biologic prior to study start
* Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start
* Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to study start
* Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start
* Subject is currently using lithium or Plaquenil (hydroxychloroquine)
* Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE (e.g., lisinopril) inhibitor at a dose that has not been stabilized
* Subject is pregnant, lactating, or is planning to become pregnant during the study
* Subject is currently enrolled in an investigational drug or device study
* Subject has used an investigational drug or investigational device treatment within 30 days prior to study start
* Subject has been previously enrolled in this study and treated with a test article
Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits

Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa

Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* BMI between 18.5 and 30 kg/m2
* Sedentary to moderate physical activity habits

Exclusion Criteria:

* Consumption of dietary supplements, antioxidants or anti-inflammatory medication, such as aspirin, ibuprofen, naproxen, or any medication that can affect the study outcomes
* Actively smoking
* Suspected abuse of alcohol or illicit drugs
* Significant illness within two weeks prior to study start or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study
* Subject who cannot be expected to comply with study procedures
* Currently participating or having participated in another clinical trial during last 4 weeks prior to the beginning of this study
* Consumption of chocolate or its derivates 24 hours before the blood sample taken
VIDAS® NEPHROCLEAR Diagnostic Accuracy Study

This is a multi-center sample analysis study in which urine samples previously collected from persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to validate the VIDAS® NEPHROCLEAR™ CCL14 Test

The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI), as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment.

The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older.

The objective of this study is to evaluate the diagnostic accuracy of the VIDAS® NEPHROCLEAR™ CCL14 test when used on the VIDAS® 3 instrument. Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), likelihood ratios (LR), and relative risk (RR), will be evaluated at the pre-determined cut-off values.

Previously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in this study. The VIDAS® test results will be compared to the clinical AKI status established by independent adjudication by medical professionals, that are blinded to the VIDAS® test results.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 21 years of age or older;
* Receiving care in an intensive care unit;
* Expected to remain in the ICU for at least 48 hours after enrollment;
* Use of indwelling urinary catheter as standard care at the time of enrollment;
* Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
* Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
* Documented informed consent provided by patient or legally authorized representative (LAR).

Exclusion Criteria:

* Prior kidney transplantation;
* Comfort-measures-only status;
* Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
* Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic); (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
* Special populations, pregnant women, prisoners or institutionalized individuals;
Application of New Technologies in the Resection of Intracranial Tumors

Main Outcome: To assess the effectiveness of new intraoperative technologies in the resection of intracranial tumors.

Design: Prospective observational study.

Method: Prospective observational study of the use and effectiveness of intraoperative neuronavigation ultrasound, intraoperative tractography, intraoperative fluorescence, advanced neuronavigation and intraoperative neurophysiology in the resection of intracranial supratentorial tumors.

Number of patients: 70 - 100.

Duration of the study: 3 years.

Ethical considerations: The study will be carried out following the international ethical recommendations for medical research in humans. Before beginning the study, the Ethical Committee of the Hospital of Santa Creu i Sant Pau approved the study protocol. It is about the study of surgical techniques that we use in our usual clinical practice.

Fundings: There are no funding sources.


Eligibility Criteria:
Inclusion Criteria:

* intraaxial brain tumors that are tributary to surgical treatment.

Exclusion Criteria:

* extra-axial brain tumors.
Clinical, Functional and Inflammatory Evaluation in Asthmatic Patients After a Simple Short-Term Educational Program

Background: Patient education is one of the pillars of asthma treatment according to GINA guidelines. It has considered essential for adherence to treatment and for correct technique of inhaled devices.

Objective: analyze clinical, functional and inflammatory features of adult patients with partly controlled and uncontrolled asthma, before and after an educational intervention. Methods: 58 adult asthmatic patients (18-70 years old) were randomized into two groups: intervention group (IG) (n=38) or control group (CG) (n=26). IG patients were submitted to three 30-minutes intervention of a shortterm educational program delivered by a nurse in 3 visits with a one-month interval. CG group did not receive educational intervention. All patients were submitted to a spirometry, induced sputum collection, nitric oxide measure, collecting exhaled condensed (cytokine analysis) air and it's ph measure, Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ), Beck Depression Inventory (BDI), and answered a symptoms diary, Statistical analysis: repeated measures (Sigma Plot Software 3.0).

Eligibility Criteria:
Inclusion criteria:

* Non-smokers or those who stopped smoking more than five years ago
* Age between 18-69 years
* Be legally capable
* Response to the short-acting bronchodilator FEV1\> 12% and\> 200 mL
* Absence of upper airway infection during 30 days and associated systemic diseases

Exclusion criteria:

* Smokers
* Over 70 years old
* Airway infection
* Legally incapable persons
* Diseases that may affect respiratory function
A Clinical Study of Furmonertinib in the Treatment of EGFR-Mutated NSCLC With Leptomeningeal Metastases

This study adopts a retrospective design. Patients enrolled will include those who received furmonertinib (treatment duration ≥1 month) between March 3, 2021, and December 31, 2024, with concurrent therapies permitted (e.g., radiotherapy, intrathecal chemotherapy, surgical interventions such as ventriculoperitoneal shunting). A retrospective analysis will be conducted to investigate the efficacy and safety of furmonertinib-based therapy (with or without other treatments) in EGFR-mutated NSCLC patients with leptomeningeal metastasis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years, male or female;
2. Histologically or cytologically confirmed diagnosis of \*\*non-small cell lung cancer (NSCLC);
3. " EGFR mutation-positive"(classic or non-classic mutations) confirmed by genetic testing;
4. "Leptomeningeal metastasis" definitively diagnosed by investigators based on "EANO-ESMO diagnostic criteria", involving comprehensive clinical assessment including symptom evaluation, imaging evaluation (MRI/CT), and/or cerebrospinal fluid (CSF) cytology;
5. Received furmonertinib (treatment duration ≥1 month) between "March 3, 2021, and December 31, 2024", with concurrent therapies permitted (e.g., radiotherapy, intrathecal chemotherapy, surgical interventions such as ventriculoperitoneal shunting).

Exclusion Criteria

1. History of other malignancies during NSCLC treatment or prior to diagnosis, except those effectively controlled (e.g., complete remission ≥5 years);
2. Severe gastrointestinal disorders affecting drug administration or absorption, including but not limited to peptic ulcer disease, inflammatory bowel disease, or malabsorption syndromes;
3. Evidence of uncontrolled systemic diseases (e.g., uncontrolled hypertension \[BP \>140/90 mmHg despite treatment\], diabetes mellitus \[HbA1c \>8%\], arrhythmias, heart failure \[NYHA class III/IV\], active bleeding, active infections requiring IV antibiotics, or interstitial pneumonia requiring corticosteroid therapy), which in the investigator's judgment may directly compromise patient prognosis;
4. Incomplete medical records or follow-up data;
5. Pregnancy or lactation;
6. Other severe acute/chronic medical conditions, psychiatric disorders, or laboratory abnormalities that, in the investigator's opinion, may confound the interpretation of study results.
Prevalence of Gastroesophageal Reflux During Childhood and Teenage Years in France

The purpose of this study is to assess prevalence of gastrooesophageal reflux during childhood and teenage years in France and to describe patients'symptoms and gastrooesophageal reflux management


Eligibility Criteria:
Inclusion Criteria:

* children from 0 to 17years old seen in consultation

Exclusion Criteria:
A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure

The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.


Eligibility Criteria:
Inclusion Criteria:

* \>= to 18 years of age
* Hypertension uncontrolled on current monotherapy
* Females:
* negative serum pregnancy test at screening
* post menopausal or have had a hysterectomy or tubal ligation or practicing approved methods of birth control

Exclusion Criteria:

* Pregnant females
* Uncontrolled hypertension with multiple drugs, except for hydrochlorothiazide/triamterene
* Diabetes requiring insulin
* Serious disorders that may limit the ability to evaluate the efficacy or safety of treatment
* History of myocardial infarction, bypass graft, angioplasty or heart failure within the past 6 months
* History of Class III or IV congestive heart failure
* History of stroke or transient ischemic attack within the last 1 year
Effect of Yogurt With Polydextrose,L Acidophilus and B Lactis in Chronic Constipation

Background and aims:Constipation is a frequent complaint and the combination of a prebiotic and probiotics would have a potentially synergic effect on the intestinal transit. The present study therefore aims to investigate the combination of polydextrose (Litesse®), L. acidophilus NCFM® and B. lactis HN019 in a yogurt on intestinal transit in subjects who suffer from constipation.

Methods: Patients with constipation were randomly divided into two groups, Placebo Group (PG) and Treatment Group (TG), and had to eat 180 ml of unflavored yogurt every morning for 14 days. Those in the CG received only yogurt, while the TG received yogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513). Expect that patients who took a combination of polydextrose has a decrease in the colonic transit time (CTT) when comparing initial and final transit time.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chonic constipation
* agachan between 10 and 20
* bowel transit time with ingestion of 24 radiopaque markers (Sitzmarks) and retention of 80% of them on day 5

Exclusion Criteria:

* Patients with hypothyroidism
* antidepressant users
* normal colonic
* transit time (24 hrs or less) as well as higher than 96 hours were
Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode

Controlled, prospective, qualitative and quantitative trial. The goal of this trial is to evaluate the mutual assistance early intervention device efficacy and its impact on insight and personal recovery of participants living with a first psychotic episode. This intervention lasts 5 days with 1 session per day of 1 hour 30 minutes. Three evaluations, before the intervention, after intervention and 1 month after the hospitalization's end.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman between 18 and 40 years old
* First psychotic episode under the guidance of a doctor
* Brief psycotic trouble (SM-V)
* Presenting a first psychiatry hospitalization (all modalities hospitalizations combined)
* Fluent in French language (read and written)
* Patient affiliated to a social protection system or beneficiary of Medical Aid of State
* Patient having signed informed consent for his participation in the protocol

Exclusion Criteria:

* Patients whose clinical condition does not allow them to participate in research
* Patients placed in isolation rooms during the intervention
Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP

Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI procedures, the immunogenicity and safety of the combined immunization group and the individual vaccination groups will be compared and analyzed.

It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be carried out as soon as possible, and the immunogenicity and safety studies should also be conducted. Currently in China the vaccination schedules of sIPV and DTaP overlap at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the possibility of simultaneous vaccination, we design this clinical study of simultaneous vaccination of the two vaccines.

To be specific, the subjects were divided into 3 groups. Group 1 : sIPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) were simultaneously inoculated at 3,4,5 months old ; Group 2 : received 1 dose of sIPV at 3,4,5 months old ; Group 3 : received 1 dose of DTaP at 3,4,5 months old . Blood sample would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody would also be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 3 months old at the date of recruitment;
* with informed consent signed by parent(s) or guardians;
* parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
* subjects have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines;

Exclusion Criteria:

* subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
* allergic to any ingredient of vaccine or with allergy history to any vaccine;
* subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
* administration of immunoglobulins within 30 days prior to this study;
* acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
* have a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
* any serious chronic illness, acute infectious diseases, or respiratory diseases;
* severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
* any kind of infectious, purulent, or allergic skin diseases;
* any other factor that makes the investigator determines the subject is unsuitable for this study.