cyrilzakka/clinical-trials huggingface dataset:
Educational Intervention on Celiac Disease and Gluten-free Diet Through Social Networks (GLUTLEARN Project).

Celiac disease (CD) is an autoimmune disease that occurs in people who are genetically predisposed to gluten consumption (1). The prevalence of the disease is about 1-2% and it is more common in women than in men, and in children than in adults (2).

The only current treatment for celiac disease is a strict, lifelong gluten-free diet. This involves the complete elimination of gluten from the diet. Gluten is not only present in some cereals such as wheat, rye, barley and oats, but is also found in many foods that have been processed. In addition to being safe, the gluten-free diet must also be balanced.

Following a gluten-free diet creates psychological and social problems for the people who have to follow it (3). It has been seen in several studies that people with celiac condition can feel different and excluded, as it is difficult to eat out, to make sure that the food is gluten-free and to avoid cross-contact (4-8).

Due to the complicate situation of people with celiac disease, they do not hesitate to seek information about the management of their diseas. That is why people with celiac disease turn to social networks, as a rapid, visual and accessible way to share information (9-11).

In line with the objectives of the University to which the Gluten3S research group belongs to (University of the Basque Country, UPV/EHU), the group has been aware for some time of the importance of disseminating science on social networks in order to make the results of the research reach the general public. It is considered that creating a nutritional education programme about CD and Gluten-Free Diet (GFD), delivered by experts in the field, could be useful in improving knowledge and attitudes about this matter. This will empower people with CD to improve their self-care and take control of their situation. Furthermore, it is also interesting to design the programme in such a way that the impact of the intervention can be measured, always with the intention of continuous improvement and reaching people with celiac disease and their environment in an effective way.

The educational intervention will be carried out for one month and is aimed at adults with coeliac disease or adults with coeliac relatives who are involved in their care. Each day a post will be uploaded to Instagram with specific, accurate and current information. The content of the intervention has been divided into 5 main blocks: 1) general concepts about CD, 2) balanced GFD, 3) food labelling, 4) cross-contact/cross-contamination, 5) new research on CD and useful resources for disease management.

The evaluation of the intervention will be carried out through pre- and post-intervention questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Be of legal age
* Have celiac disease or be involved in the care of a person with celiac disease
* Be an Instagram user
Video Education and Behaviour Contract to Optimize Adherence in Renal Transplants

This study aims to test the effectiveness of an electronic-based video intervention and behavioral contract on improving medication adherence among kidney transplant recipients.

Non-adherence to immunosuppressive medications is a major problem after kidney transplantation, leading to increased rejections, hospitalizations and health care expenditures. Effective educational opportunities may positively influence adherence, especially when combined with a behavior intervention. However, increasing education and support to transplant recipients demands greater use of care providers' time and resources in a health care system that is already stretched.

A patient-oriented video series has been developed according to best practices for transplant education, featuring an animated character embarking on a transplant journey. Animated segments illustrate difficult concepts for patients with poor health literacy, and patient narratives provide support and encouragement. A multicenter randomized controlled trial will be conducted with 4 sites across North America. Patients will be randomized (1:1) to either the intervention (i.e., home-based video education + adherence contract plus usual care) or usual care alone. Patients will be enrolled in the study prior to hospital discharge and will be provided with access to the video intervention and contract electronically. The primary outcome will be adherence at 12 months post-transplant, as measured by self-report (BAASIS), and variability in immunosuppressant levels. Secondary outcomes include the change in knowledge score between the intervention and control in groups (measured by the Kidney Transplant Understanding Tool); differences in self-efficacy (Generalized Self-efficacy Scale), beliefs about medicines (Beliefs of Medicine Questionnaire), and quality of life (SF-12). Individualized viewing statistics will be analyzed to determine patient uptake, and satisfaction about the educational experience will be captured on a self-reported survey.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* can speak and understand and read English
* receive their first kidney transplant at one of the participating sites during enrolment

Exclusion Criteria:

* do not meet inclusion criteria
* have previously participated in a study entitle "Improving health outcomes of kidney recipients: A randomized controlled trial of a pre-transplant education intervention"
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)

The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

Study KTE-C19-102 (NCT02601313) enrolled participants with r/r MCL who have been treated with up to 5 prior regimens including a Bruton's tyrosine kinase inhibitor (BTKi) in Cohort 1 and Cohort 2. However, to fulfill FDA Postmarketing Requirement Cohort 3 is added to the study. It will include participants with r/r MCL who have been treated with up to 5 prior regimens but have not received prior therapy with a BTKi.

The primary analysis in Cohort 1 and Cohort 2 is already completed. Data for Cohort 3 will be analyzed separately. Therefore, this separate registration is only for Cohort 3.

After the end of KTE-C19-102, subjects who received an infusion of anti-CD19 CAR T cells will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

Eligibility Criteria:
Key Inclusion Criteria:

* Up to 5 prior regimens for MCL. Prior therapy must have included anthracycline- or bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy. Individuals must not have received prior therapy with a BTKi.
* At least 1 measurable lesion
* Platelet count ≥ 75,000/uL
* Creatinine clearance (as estimated by Cockcroft Gault) ≥ to 60 cc/min
* Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA), and no clinically significant electrocardiogram (ECG) findings
* Baseline oxygen saturation \> 92% on room air

Key Exclusion Criteria:

* Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). Individuals with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing
* History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement
* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome

The purpose of this study is to assess the effects of ethinylestradiol 30µg-drospirenone combined with metformin and weight loss by means of dietary intervention on the indices of endothelial dysfunction (i.e. flow-mediated dilation and serum endothelin-1), serum hsCRP,lipids,insulin resistance and body composition in young women with PCOS.

Women with polycystic ovary syndrome (PCOS) frequently cluster several cardiovascular risk markers and early subclinical atherosclerosis. Because combined oral contraceptives (COCs), the most common treatment of this disease, might adversely influence insulin resistance, glucose tolerance, lipid profile or aggravate chronic inflammation the possibility of worsening the already unfavorable cardiovascular risk profile of PCOS subjects is of concern. On the contrary, the insulin sensitizer metformin has been shown to ameliorate insulin resistance, reduce hyperandrogenism and triglyceride levels and also to improve endothelial structure and function in PCOS. Drospirenone (DRP) is a progestin with antiandrogenic and antimineralocorticoid activity. However, the studies assessing the effect of the COC containing 30 µg EE+3mg DRP (DRP/EE30µg) on surrogate markers of atherosclerosis are few and inconclusive. Therefore,the purpose of the present study is to assess the effects of the oral contraceptive DRP/EE30µg combined with metformin and weight loss by means of dietary intervention on the indices of endothelial dysfunction, i.e. flow-mediated dilation and serum endothelin-1, serum hsCRP,lipids, and insulin resistance in young women with PCOS.

Eligibility Criteria:
Inclusion Criteria:

* women with diagnosis of polycystic ovary syndrome defined according to Androgen Excess Society 2006 guidelines

Exclusion Criteria:

* secondary causes of hyperandrogenism such as hyperprolactinemia, thyroid disease, androgen-secreting tumours, Cushing's syndrome and congenital adrenal hyperplasia
* current or previous use (within 6 months) of oral contraceptives, anti-androgens, ovulation induction medications
* use of drugs known to affect carbohydrate-lipid metabolism or inflammation (anti-inflammatory drugs) at the time of evaluation and during the last one month preceding the evaluations
* concurrent minor infection reported during the last one month preceding the evaluations
* personal history of diabetes mellitus
Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients

This is a research that will investigate the safety and efficacy of virgin coconut oil (VCO) as an adjunctive therapy for Coronavirus Disease 2019 (COVID-19)

This study will be a randomized controlled trial among hospitalized COVID-19 patients, aged 18 years old and above, admitted at the Philippine General hospital. Patients will be grouped into the following:

1. Group receiving standard of care
2. Group receiving standard of care plus virgin coconut oil (15ml, 3x/day for 2 weeks) as adjunctive therapy.

Patients will be observed as regards to primary outcomes such as recovery/resolution of symptoms and duration of hospital stay

Eligibility Criteria:
Inclusion Criteria:

* symptomatic and asymptomatic COVID-19 hospitalized patients
* has laboratory-confirmed illness during the time of recruitment
* able to take food and medicines enterally

Exclusion Criteria:

* uncontrolled or newly diagnosed diabetes mellitus
* with chronic heart disease
* having elevated lipid profile at baseline (admission)
The Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy

A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy and safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with essential hypertension uncontrolled with valsartan 160mg monotherapy


Eligibility Criteria:
Inclusion Criteria:

* 19 aged or over
* A patient who was diagnosed with essential hypertension at screening(Visit 1)
* A patient understood objective of this clinical trial and gave their written informed consent voluntarily

Exclusion Criteria:

* A patient with severe hypertension(MSSBP≥200mmHg or MSDBP≥120mmHg) at Visit 1
* A subject with difference(as MSSBP≥20mmHg or MSDBP≥10mmHg) in blood pressure between right and left arm at screening evaluation
* Medical history or evidence of a secondary form of hypertension
* A subject with history of hypersensitivity to CCB(Calcium Channel Blocker), ARB(Angiotensin II Receptor Blocker) or sulfonamide
Circulating Tumor Cells and Neutrophils Count for Colorectal Metastatic Cancer

Colorectal cancer represents a major public health problem in France because of its high incidence and severe prognosis. Early stages of the disease are well know and have justified the establishment of a mass screening strategy. Unfortunately, the factors determining the progression to metastatic disease about them much harder to grasp. Various prognostic factors and predictors of treatment response have been identified and are being used but most of them are In practice, they are sometimes coarse and relatively little discriminant for patients.

It is now possible to directly quantify the amount of circulating tumor cells in peripheral blood. Quantification of circulating tumor cells beyond a threshold of 3 cells/7,5 ml has been established as a major prognostic factor, and the rapid decrease in the number of these cells under treatment is also a predictor of response for patients suffering from metastatic colorectal cancer . Furthermore, it has also been shown that the quality and importance of the systemic and peritumoral inflammatory response in carcinomas, including colorectal, played a key role in the prognosis of patients. In particular, the presence of high levels of blood neutrophils has been raised by many studies as being followed by a poorer prognosis.

However, the correlation between the presence of circulating tumor cells and high levels of neutrophils has never been studied. There is a rational to assume that this association exists, and secondly that the presence of circulating tumor cells in a proinflammatory environment represented by a high levels of blood neutrophils promotes metastasis by exerting a negative synergistic effect on the prognosis of patients.

The main objective of this pilot study is to find a correlation between the amount of circulating neutrophils and the presence of circulating tumor cells in patients with colon cancer metastatic unresectable non-pretreated. The secondary objective is to investigate whether this association results in a negative synergistic effect in terms of progression-free survival and survival to one year. This is a non-interventional study. The investigators expect the inclusion in one year of thirty patients in two centers (University Hospital Centre Antoine Lacassagne Nice) to achieve these goals.


Eligibility Criteria:
* Inclusion criteria:

  * Age \> 18 years
  * Metastatic colorectal cancer
  * Chemotherapy required
  * Measurable scannographic target
  * CT-scan \< 3 weeks
  * Written consent

Non-inclusion criteria :

* Personal history of invasive carcinoma
* Prior chemotherapy regimen
* Treatment with G-CSF analogs
* Corticotherapy

Exclusion criteria:

• Consent withdrawal
Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI

Background:

The presence of orthostatic hypotension (OH) as a consequence of blood volume redistribution during verticalisation in persons with spinal cord injury (SCI) is a common condition.

Aims:

To investigate the impact of three different types of electric stimulation (ES) (ES of the abdominal muscles versus ES of lower limb muscles versus simultaneously ES of abdominal and lower limb muscles versus control) on blood pressure stabilization and verticalisation-degrees between 0° and 70°. The hypothesis is, that the ES-induced contractions of the muscles cause a stabilisation respectively an increase of the blood pressure during the tilt-table test.

Subjects:

20 Women and men, at least 18 years of age, following an acute and traumatic SCI, with a lesion level above T6, an American Spinal Injury Association (AIS) Impairment Scale A,B or C and a diagnosis of OH (by tilt table test) were eligible for the study.

Methods:

Each patient underwent randomly three different types of ES sessions while being positioned on a tilt-table. The following sessions were planned:

A) ES of the abdominal muscles B) ES of the lower limb muscles C) Combination of A and B D) Control session (=diagnostic session)

Study type: Intervention Design: Prospective interventional study


Eligibility Criteria:
Inclusion Criteria:

* inpatients
* positive diagnosis of OH
* acute traumatic SCI
* lesion level above T6
* AIS A, B or C

Exclusion Criteria:

* fractures of the lower limbs
* decubitus (NPUAP \>2)
* massive psychiatric dysfunction
* suicide intention
Beta 2 Adrenergic Stimulation vs Cold Exposure to Activate Human Brown Adipose Tissue

The purpose of the study is to asses brown adipose tissue activity in humans after intravenous administration of the selective beta-2-adrenergic agonist fenoterol as compared to the natural activator of brown adipose tissue, a mild cold stimulus.

The activation of brown adipose tissue in response to beta-2-adrenergic stimulation as compared to cold exposure will be studied in an open-label, cross-over trial in healthy volunteers with random sequence of the two study interventions a) and b):

1. A bolus of 25µg fenoterol will be slowly injected intravenously during 2-3 minutes followed by a continuous infusion of fenoterol 1µg/min over 120 minutes. The total dose of fenoterol per subject will thus be 145µg.
2. During 120 minutes participants will be exposed to a mild cold stimulus water using cooling sleeves, covering the participant's waist, is gradually decrease body surface temperature to 10 degrees or to the lowest tolerable temperature without shivering.

Energy expenditure will be measured during both interventions by indirect calorimetry and brown adipose tissue activity will determined by 18F-FDG-PET/CT 30 min after injection of 75 MBq of 18F-FDG.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18,5-23 kg/m2 or 30-35 kg/m2

Exclusion Criteria:

* History or signs of any medical or psychological condition
* pregnancy or lactation
* medications except prescription free analgesics and contraceptives
* habitual alcohol or tobacco use
* weight change \>5% within prior 3 months
* Resting heart rate \>85 bpm
* Systolic blood pressure \>140 mmHg or diastolic blood pressure \<50 mmHg
* Presence of following ECG changes: ST-segment deviations, QTc \>500ms, signs of pre-excitation
* Hyper- or Hypothyroidism
* inability to follow study procedures
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* hypersensitivity to cold
* enrolment into study with ionizing radiation within prior 12 months.
* Cold induced thermogenesis of less than 5% basal metabolic rate and normal weight or cold induced thermogenesis of more than 5% and overweight (determined during screening visit)
Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study

A Three-arm, Randomized Controlled Trial for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety: Intranasal Midazolam by SipNose versus MAD Versus oral administration


Eligibility Criteria:
Inclusion Criteria:

* every child \>1y who is intended for medical procedure in the emrgency room(suce as: IV insertion, blood sample collection, urinary catether insertion, laceration repair

Exclusion Criteria:

* ASA\>2
* Active respiratory infection
* systemic illness
* Allergy to Midazolam
Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD

This study evaluates the ability to support diagnosis and monitor of the dynamics in ADD/ADHD subjects with an easy to use EEG Device.

The study will be conducted in two arms (arm I and arm II). In arm I, participants diagnosed with ADD/ADHD. In arm II, healthy participants.

The status of the participants will be evaluated with questionnaires computerized test and EEG characteristics will be collected for all study participants. .

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged 18 -45 years.
* Able and willing to comply with all study requirements.

Diagnosed with ADD/ADHD based on clinical evaluation based on the questionnaires:

* Adult ADHD Self-Report Scale (ASRS)
* Wender-Utah Rating Scale
* Positive And Negative Affect Schedule (PANAS)

Exclusion Criteria:

Diagnosed with Psychotic or bipolar disorder.

* Diagnosed with a substantial Neurological disorder or general medical condition with an effect on EEG patterns such as Epilepsy or stroke
* A user of recreational or illicit drugs or has had a recent history (six months) of drug or alcohol abuse or dependence.
* Cognitive impairment.
* Hearing disorder and/or known ear drum impairment.
Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab

This extension study is designed to enroll participants with hematologic malignancies who are receiving clinical benefit from tafasitamab treatment in a parent study with tafasitamab..


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Having been enrolled and is still receiving treatment with tafasitamab at the end of a parent tafasitamab clinical study.
* Is tolerating tafasitamab treatment at the dose specified in the parent protocol as assessed by the Investigator.
* Is in complete/partial response or stable disease and is receiving clinical benefit from treatment with tafasitamab in the parent study, as assessed by the Investigator.
* Has demonstrated compliance, as assessed by the Investigator, with the parent protocol requirements.
* Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.

Exclusion Criteria:

* Patient who is legally institutionalized, or under judicial protection.
* Has met one or more criteria for permanent tafasitamab treatment discontinuation as stipulated in the parent protocol.
* Able to access tafasitamab outside a clinical study.
* Patient with an uncontrolled intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
* A female patient who is pregnant confirmed by a pregnancy test prior to enrollment, breastfeeding, or a woman of childbearing potential (WOCBP) who does not agree to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment, and does not refrain from donating oocytes during this period.
* A male patient who does not agree to use contraception as detailed in the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment (if they have a heterosexual partner who is a woman of childbearing potential) and who does not refrain from donating sperm during this period.