cyrilzakka/clinical-trials huggingface dataset:
ANAIS, a Spanish Version of the DAFNE Programme

ANAIS is a therapeutic education programme for type 1 diabetes based on a flexible insulin regime adjusted to the patient's food intake. Participants are randomised in two groups, to attend the training course immediately (immediate ANAIS) or a year later (delayed ANAIS). The main outcome was HbA1c at one year.

ANAIS (Alimentación Normal con Ajuste de InSulina) is a Spanish version of the DAFNE programme, performed in patients with type 1 diabetes. ANAIS is a randomised, controlled, parallel trial.

ANAIS is a group-based, therapeutic education programme for type 1 diabetes based on a flexible insulin regime adjusted to the patient's food intake.

Participants with type 1 diabetes and an HbA1c between 7 and 10% were recruited from the outpatient clinics in a tertiary care center. They were randomised (opaque, sealed envelopes, 2:1 ratio) to attend the training course immediately (immediate ANAIS) or a year later (delayed ANAIS).

The main outcome was HbA1c at one year. Secondary outcomes included lipids, weight, hypoglycemic events, treatment satisfaction, quality of life and self-defined objectives.

Eligibility Criteria:
Inclusion Criteria:

We considered patients to be eligible if they were aged over 18 years, had type 1 diabetes, had an HbA1c between 7-12%, (or HbA1c \< 7% with a history of severe hypoglycemia), duration of diabetes of more than two years without advanced complications and ability to understand written and spoken Spanish.

Exclusion Criteria:

Exclusion criteria included severe psychiatric illness, pregnancy, or other circumstances that, according to the investigators' criteria, could interfere with study completion.
Social Deprivation and Pregnancy

Social deprivation during pregnancy is associated to adverse perinatal outcomes. However, prenatal screening of social deprivation by reliable measurement is not performed. Prevalence of social deprivation is yet underestimated during pregnancy and vulnerable women are not being provided optimal prenatal care.

Our aim is to validate EPICES score during pregnancy.

The process of deprivation was defined first by J. Wrezinski and P. Townsend who also reported that deprivation is the main cause of inequalities in health. Several studies have already shown an association between socioeconomic deprivation and adverse birth outcomes. EPICES score is the only one that measure individual deprivation. The EPICES score should be therefore included systematically in standard follow-up of pregnant women.

Descriptive analysis will assess women's characteristics and prevalence of social deprivation. Two groups of women will be compared deprived women and non-deprived women.

Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression.

Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* delivery at 2 maternity hospitals of Clermont-Ferrand area
* fluent command of spoken and written French

Exclusion Criteria:

* Terminations of pregnancy
* protected women
Research Biobank From Neuromuscular Biopsy Residues (in the Context of Care)

Neuromuscular diseases are rare diseases for which significant progress has been made in the context of diagnosis thanks to advances in molecular techniques, but the intimate mechanisms of lesion formation remain poorly understood. Advances in cellular and molecular biology, the development of a few animal models, such as transgenic mice, which make it possible to mimic human pathology have made it possible to better understand the physiopathology of these diseases. However, they still do so very imperfectly and incompletely, making it even more necessary than ever to study diseased human muscle tissue to find new avenues of research or to confirm results obtained by experimentation.

The purpose of this collection of tissue samples for neuro-muscular purposes is to collect such samples under the best conditions in order to promote basic and translational research on muscle diseases.

This is why the CHU de Bordeaux wishes to keep the remainders of samples taken as part of the treatment to constitute a collection of biological samples and associated data kept according to quality standards and in compliance with the regulations in force.

The "COLMYONEU" project is a project to collect leftover frozen neuromuscular biopsy samples from patients taken as part of their health care at the Bordeaux University Hospital for neuromuscular disease.

Its main objective is to store, under the conditions of the CRB standard, residual biological samples from patients with neuromuscular symptoms.

Eligibility Criteria:
Inclusion criteria

* Patients treated at Bordeaux University Hospital (neurology services, neuropediatrics), rheumatology, medical genetics for suspected neuromuscular disease.
* Men and women are affected, adults and minors.

Exclusion criteria

- no exclusion criteria
Intralymphatic eASC Administration in Healthy Volunteers

The objective is to determine the safety, tolerability and feasibility of the inguinal intralymphatic administration of expanded allogeneic adipose-derived stem cells (eASCs)

Phase I, unicentric, single blind, clinical trial with healthy volunteers to determine the feasibility of a new administration technique.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 55 both included
* Inform Consent Form signed
* Body Mass Index (BMI) between 19 and 29 kg/m2
* Presence of, at least, one lymph node of 1cm in its larger diameter in each inguinal location. It has to be accessible for administration after its localization using ultrasound scan.

Exclusion Criteria:

* Pregnant (positive to urine pregnancy test) or breastfeeding women.
* Subjects with history of any organic or psychic pathology in their records, physical exploration or any complementary test.
* Any relevant current pathology, including cancer, liver pathology, gastrointestinal dysfunction, renal alteration, respiratory pathology or active acute infectious problems.
* Chronic disorders or previous recurrent like hypertension, infections, cardiovascular, respiratory, endocrine, neurologic, hematologic, renal or liver disorders.
* Subjects treated four weeks before the first administration with any drug, medicinal plant or Consumer Health Care in a continue routine. It is not consider exclusion criteria a sporadic medication. The physician will study the interaction between the eASC with this medication.
* History of hypersensibility to drugs.
* Volunteers participants in other clinical trial within 4 months prior the start of the study.
* Blood or derivatives transfusion in 6 months before the trial.
* Known history of abuse of alcohol or other addictive substances(amount of alcohol allow as maximum in this trial is 0.5 liter of wine or two beers or amount in grams equivalent to this of any other alcoholic drink).
* Illegal drugs consumption during the month before the enrollment in the study or positive result to a drug test.
* Positive serology for B hepatitis virus (HbsAg), C hepatitis virus or HIV (Human Inmunodeficiency Virus).
* Subjects whose freedom depends on legal or administrative requirements.
Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class 1 or 2 physical status;
* 18 to 65 years of age (inclusive);
* Scheduled for elective surgical procedure under general anesthesia requiring a short duration of neuromuscular block with the use of rocuronium or succinylcholine and requiring endotracheal intubation;
* Scheduled for surgery in supine position;
* Body mass index (BMI) \< 30;
* Given written informed consent.

Exclusion Criteria:

* Has ischemic heart disease or history of myocardial infarction within the last year;
* May experience difficult intubation due to anatomical malformations;
* Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
* Known or suspected family history of malignant hyperthermia;
* Known or suspected allergy to narcotics, muscle relaxants, midazolam, anesthetics or other medications used during surgery;
* Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
* Individuals in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
* Females who are pregnant or breast-feeding;
* Females of childbearing potential who are not using an acceptable method of birth control \[condom or diaphragm with spermicide, vasectomized partner (\> 6 months), IUD, abstinence\];
* Has already participated in a sugammadex trial including Protocol 19.4.303.
The Yield of Laryngeal Ultrasound in the Evaluation of Stridor and Dysphonia in Children

Stridor is a respiratory noise caused by partial obstruction of the large airways at the level of the pharynx, larynx and/or trachea. The second most common cause of stridor is vocal cord paralysis.

Awake nasolaryngoscopyn (ANL) is regarded as the gold standard for the diagnosis of laryngomalacia. However, ANL has some drawbacks as it may cause discomfort for the patient and the laryngeal view may be obscured due to patient movement or anatomical variations.

Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique. Evaluation of the dynamic characteristics of the glottis by US revealed perfect reliability in comparison to nasolryngoscopy suggesting that US can be useful in the assessment of laryngeal adduction.

The investigator hypothesize that laryngeal US can be an accurate and reliable adjunct in the diagnosis of functional and anatomical causes of stridor and dysphonia in the pediatric population.


Eligibility Criteria:
Inclusion Criteria:

children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre will undergo US of the larynx.

Exclusion Criteria:

* None
Maintenance Hormonal Therapy and DLBCL

the study aims to detect the benefit of maintenance tamoxifen after achieving CR with conventional immuno-chemotherapy and/or radiotherapy in patients with DLDCL

Diffuse large B-cell lymphoma (DLBCL) is the most common form of aggressive non-Hodgkin lymphoma. The standard immuno-chemotherapy (R-CHOP) markedly improves the prognosis of DLBCL, but up to 40% of patients still experience relapse or incomplete remission . So, there is a need for new targeted therapy for such malignancy. Recent studies identified a potential novel target in DLBCL, the ESR2 gene, which codes for the estrogen receptor beta (ERβ) protein, a receptor that can be targeted with selective ER modulators (SERMs) such as tamoxifen. Recent data shows that exposure of DLBCL cell lines to tamoxifen (either alone or in combination with CHOP chemotherapy) results in apoptosis and growth inhibition in vitro and in vivo. these data suggest the potential importance of ERβ in the pathogenesis of DLBCL as well as a potential role for tamoxifen in the treatment of DLBCL.50-100 patients with newly diagnosed DLBCL will be treated with standard immuno-chemotherapy according to disease stage with detection of ERB and ERA on the tissue samples using IHC. After the end of chemotherapy treatment patients who achieve CR will be randomized to either receive tamoxifen maintenance (20 mg daily) versus follow up to evaluate possible tamoxifen effect on disease recurrence, DFS and OS.

PT who achieve CR after 2nd line chemotherapy versus post BMT will also be recruited.

Eligibility Criteria:
Inclusion Criteria:

adults 18-75 years old newly diagnosed DLBCL patients who achieve CR after conventional primary treatment can be included PS 0-2

Exclusion Criteria:

less than 18 years or older than 75 years other types of lymphoid neoplasms cardiac comorbidity
A Model for Healthy Aging: Moscow Centenarians (AGE-100)

This study evaluates the associations between biomarkers of ageing, comprehensive geriatric status, telomere length and progerin level, the composition of the gut microbiota, 16sRNA metagenome sequencing in Moscow centenarians.

The global average life expectancy and the average age of the population are growing steadily along with the age-related diseases. The same trend is also observed in our country. Although, maximum life span in Russia decreases. E.g., the number of centenarians in Moscow decreased by 244 persons from 2013 to 2014. There were about 400 centenarians in Moscow in 2014. That is about 3.3 per 100 000 population. In the US, this figure is about 10-20, and there are 50 centenarians per 100 000 population in the Okinawa region, Japan. The rate of ageing varies substantially, a prime example of this is the centenarians population. These people break conventional stereotypes about aging. Chronic diseases in centenarians are postponed. They are more active, they work longer, they can better tolerate stressful situations. Scientists all over the world are trying to find the secret of their longevity. Studies on the medical and social aspects of centenarian longevity are actively carried out in the US, Europe, Japan, Australia. In Russia studies were carried out in St. Petersburg, Western and Eastern Siberia. According to the New England Centenarian Study, the supercentenarians (persons who have lived more than 110 years) life span is actually equal to the healthy span without serious illnesses. The aim of research is to study features of social status, lifestyle, habits, clinical status, blood chemistry, the amount of progerin, genome, composition of the gut microbiota in Moscow centenarians in order to create a model of healthy aging. In this study a comprehensive analysis of the longevity phenomenon of one hundred centenarians from Moscow and the Moscow region planning to be conducted. Analyzing of anamnesis vitae, medical, social, neuro-cognitive, and genetic features is planning. Each study participant will undergo a comprehensive geriatric assessment, including examination by the neurologist, an assessment of cognitive status,psychogeriatric consultation with the assessment of self-perceptions of aging and depression assessment by using the geriatric depression scale, neuropsychological testing using the Montreal Cognitive Assessment (MoCA), verbal recognition memory 12 word test, clock-drawing test.Telomere length and progerin level in buffy coat layer evaluation, 16sRNA metagenome sequencing, and nuclear magnetic resonance spectroscopy for qualitative and quantitative analysis of metabolites in blood serum, will be done in all participants. This study will take the science closer to the goal of identifying the patterns of "healthy" aging.

Eligibility Criteria:
Inclusion Criteria:

age over 90 years

-

Exclusion Criteria:

age under 90 years refusal to participate in the study

-
The Swedish Birth Seat Trial

The purpose of this study is to determine whether birth on a birthing seat will effect numbers of instrumentally assisted vaginal births, vaginal traumas, blood loss,use of artificial oxytocin for labour augmentation and fetal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* nulliparous women who understood the Swedish language sufficiently well to receive information and give informed consent
* a normal pregnancy,singleton fetus in cephalic presentation
* spontaneous onset of labor occurring between gestational weeks 37 + 0 and 41 + 6
* Body Mass Index less (BMI) than thirty
* gestational diabetes not requiring medical treatment
* women who were planning a vaginal birth after a caesarean section (VBAC)
* women induced because of spontaneous rupture of membranes with no spontaneous contractions for longer than twenty-four hours

Exclusion Criteria:

* multiparous women
* birth before gestational week 37
* breech presentation
* maternal BMI more than 30
* multiple pregnancy
* infectious disease
* pre-eclampsia or other conditions requiring medical care
Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers

The primary objective of the current study is to investigate the safety and tolerability of BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and healthy Japanese male volunteers following single oral administration and multiple administrations.


Eligibility Criteria:
Inclusion criteria:

1. Healthy
2. Chinese ethnicity for single rising dose (SRD) part, Japanese Ethnicity for multiple rising dose (MRD) part.
3. Age \>= 20 and age =\< 50
4. Body Mass Index (BMI) \>=18.5 and BMI =\< 25 kg/m2
5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria:

1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement
2. Any evidence of a clinically relevant concomitant disease
3. Intake of drugs with long half life (\>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration
Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms

The purpose of the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months) using optical coherence tomography.

Hypotheses:

1. The alloy composition and strut design of a drug-eluting stent has a direct bearing on stent apposition measured using OCT.
2. Stent design and alloy composition have a direct influence on radial support and scaffold shrinkage.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction
3. Presence of one or more coronary artery stenosis \> 50% in a native coronary artery with a reference diameter ranging from 2.25 to 4.25 mm which can be covered with one or multiple stents
4. No limitation to the number of treated lesions or number of vessels according to the randomization group
5. De-novo native coronary disease with complex lesions involving: Bifurcations, chronic occlusions \> 3 months, lesions \> 20mm in length or moderately/heavily calcified lesions of any length

Exclusion Criteria:

1. Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, platinum chromium, everolimus, contrast material
2. Acute ST-segment elevation myocardial infarction
3. Type A lesion including vessel angulation \<45 degrees
4. Bypass graft
5. Inability to provide informed consent
6. Pregnancy
7. Planned surgery within 12 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
8. Left ventricular ejection fraction \< 25%
9. Serum creatinine \> 180mmol/L
Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).


Eligibility Criteria:
Inclusion Criteria:

* Measurable disease based on RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function per protocol-defined criteria.
* Documentation of results from testing of human papilloma virus (HPV) status for oropharyngeal cancer.
* Baseline archival tumor specimen available or willing to undergo a prestudy treatment tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain the specimen.

Exclusion Criteria:

* Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
* Disease progression within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
* Use of protocol-defined prior/concomitant therapy.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic treatment in past 2 years.
* Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
* Known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (defined as HCV RNA \[qualitative\] is detected).
Developing and Testing a Small Private Online Course (SPOC) for Nurse-patient Communication About Sex.

This is a three-year research project. The goal is to develop and test "The SPOC-based blended teaching and learning platform (Nightingale in Gen-sEx)" that integrates effective educational strategies and e-learning methods to meet the Taiwanese nurse's learning needs. This project is aimed at resolving sexual education learning problems in nursing continuing education due to the time constraints at clinical sites and the shortage of teaching staff. Nurse-patient communication attitudes and skills about sex will be enhanced.

The research team constructed a course for hospital nurses that followed the commonly used ADDIE (Analysis, Design, Development, Implementation, and Evaluation) model. The first year research purpose is to: (1) explore the characteristics of nursing-patient communication about sex and the core educational needs content for nurses using triangulation methods. (2) Construct gender-sensitivity structures characteristics of nursing-patient communication about sex and course framework according to the modified Delphi method results and course needs assessment. The second year develops the SPOC-based blended teaching and learning platform (E-generation Angel of Happiness") and conducts a pilot study to test and correct the course content and method. In the third year a pretest-posttest randomized control group design will be implemented to investigate the effectiveness of the course "E-generation Angel of Happiness" in improving competencies of nurse-patient communication about sex, including attitudes, and practices, among nurses.

Eligibility Criteria:
Inclusion Criteria:

1. 20 to 50 years old.
2. Below N3 rank.
3. Full-time nurse in clinical care.
4. Have smartphones or computers, and be able to use and be online.
5. Nurses who are willing to participate in this study and sign the consent form

Exclusion Criteria:

1. Will leave within 3 months.
2. unable to learn online.
3. The working units are surgery room, recovery room, hospice ward, supply center.