cyrilzakka/clinical-trials huggingface dataset:
Ultrasound and Cytological Evaluation 3 Years After Radiofrequency Thermal Ablation of Benign Thyroid Nodules : a Prospective Exploratory Cohort of 180 Nodules

There is no scientific data on post-thermal ablation cytological aspects, but treated nodules that grow back significantly after a procedure justify a new cytology in order not to ignore a neoplastic process.

The EU-TIRADS classification usually used to stratify the risk of cancer (and to justify a fine needle aspiration biopsy) of thyroid nodules is not validated for nodules treated by thermal ablation (TA) (post-RF nodules). However, these nodules often acquire ultrasound criteria of suspicion making it necessary to develop an ultrasound stratification of the risk of malignancy specific to nodules treated by TA.

The objective of this work is to describe the ultrasound and cytological aspects of these treated nodules by performing a systematic assessment at 3 years after thermal ablation including systematic neck ultrasound and fine needle aspiration biopsy. Thus, an ultrasound and cytological atlas (Bethesda classification 2017) of nodules treated by thermal ablation will be constituted.


Eligibility Criteria:
Inclusion Criteria:

1. Patients \> 18 years old
2. Carrier of a benign thyroid nodule that has undergone radiofrequency thermoablation 36 months previously ± 12 months, whether the nodule is stable, progressing or decreasing in volume during the screening period and/or on the day of inclusion.
3. Obtaining written informed consent
4. Affiliation to a social security system (excluding AME)

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Previous alcohol use
3. Patients on anti-vitamin K anticoagulants
4. Patients on direct oral anticoagulants
5. Persons deprived of liberty by judicial or administrative decision
6. Persons under forced psychiatric care
7. Persons admitted to a health or social institution for purposes other than research
8. Persons of full age who are under legal protection (guardianship or curatorship)
9. Persons unable to express their consent
10. Persons under a legal protection measure (there can be no derogation for this category)
Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ

The purpose of this study is to determine whether the study drug is safe and effective.

The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.

Eligibility Criteria:
Inclusion Criteria:

- Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.

Exclusion Criteria:

- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
Biomarkers in Chronic Arthritis

Use of genotyping for the optimization of treatment with biologics in chronic arthritis by looking for an association between certain alleles and response to treatment.

Chronic arthritis in children and in adults represent a public health problem in number and difficulty of treatment. 30% of patients are non-responders and / or relapse upon discontinuation of treatment. Some of these treatments are not always well tolerated, sometimes with infectious complications including tuberculosis limiting the use of biological therapies. This study will validate a battery of genetic markers to predict responders biotherapy, determine the prognosis of patients, these treatments are reserved for the most severe forms, and thus improve the care of patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated with biotherapy may be included in this study with all information necessary for regular medical consultations (filling specific monitoring by GPs questionnaires), physical therapists visits, occupational therapists, psychologists.. etc

Exclusion Criteria:

* Patients treated with biological therapy for non rheumatic disease
* Other inflammatory diseases such as Crohn's disease
* Refusal to participate in the collection
Computer-Based Training for Cognitive Enhancement: In Home Study

The primary objective of this study is to evaluate the effects of a computer-based training program on the memory and cognitive abilities of mature individuals undergoing healthy aging.

The computer-based training program is focused on speech reception to strengthen an individual's memory for speech. This type of training program was chosen because speech perception and memory are crucial elements of human communication and losses in this area are often the first signal of overall cognitive decline.

Subjects meeting eligibility criteria and providing written, informed consent are randomized to three groups; two 40-session, computerized training programs or a no contact control group.

Eligibility Criteria:
Inclusion Criteria:

A)Participants must be at least 60 years old B)Participants must have a Mini-Mental State Exam (MMSE) score of 24 or higher to ensure that participants do not meet common criteria for dementia C)Participants must be a native English speaker D)Participants must be able to see well enough to read the consent form E)Participants must be able to hear well enough to understand ordinary spoken conversation in a slightly noisy room F)Participants must be willing to commit to the time requirements of the study and not have any scheduled trips or absences for more than 1 week during the training.

Exclusion Criteria A)Participants must not be planning to begin cholinesterase inhibitor (AChEI) therapy or to change their dosing levels. Subjects currently using AChEI will be included if they have an established steady dosing history at least one month prior to the study and are expected to continue at the same dosage throughout the study.

B)Participants must not have had a head trauma that caused them to lose consciousness.

C)Participants must not have had a stroke within the past year; or have had a stroke that has left them with expressive or receptive language problems.

D)Participants must not have any central nervous system disorder that could contribute to cognitive impairment.

E)Participants must not have a tremor preventing the use of a computer mouse or other pointing device.

F)Participants must not currently be active in another clinical trial.

Exclusion Criteria:

-
Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes.

The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Diabetes To Go: An Inpatient Diabetes Survival Skills Education Program

A learner-centered diabetes survival skills self-management education program was provided to adults with uncontrolled diabetes in the hospital and generated preliminary evidence of impact on medication adherence and a trend toward reduction in hospital and emergency department admissions.

This study was a prospective, nonrandomized pilot study conducted among adults with uncontrolled diabetes admitted to the Medicine Service of an urban tertiary teaching hospital were consented to participate in a pilot study which provided diabetes survival skills education. Based on knowledge deficits identified on a diabetes knowledge pre-test the patient was directed to view video content corresponding to those deficiencies and content on sick days and diabetes complications. Evaluation measures were diabetes knowledge, medication adherence, and hospital admissions plus emergency department visits at and/or 3months before baseline and at 2 weeks and 3 months post-discharge. There was improvement in diabetes knowledge and medication adherence, which was sustained to 3 months. A trend was observed toward reduction in emergency department and/or hospital admissions from 3 months pre-intervention to 3 months post-discharge for uncontrolled diabetes. This knowledge-based program successfully provided survival skills education to hospital patients with uncontrolled diabetes and demonstrated preliminary evidence of a positive impact on medication adherence and a trend toward reduction in hospital and emergency department admissions.

Eligibility Criteria:
Inclusion Criteria:

* English speaking with a diabetes mellitus diagnosis (ICD 9 codes 250.xx)
* an admitting blood glucose level of \> 200 mg/dL or ≤ 40 mg/dL, and
* an anticipated hospital stay of ≥ 2 days, as estimated by the medical staff, to allow sufficient time for delivery of program content

Exclusion Criteria:

* pregnancy
* admission to an intensive care unit, and
* any medical condition or cognitive dysfunction that, in the opinion of the investigator, would preclude active participation
Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Mild to Moderate Essential Hypertension

The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat）in the treatment of mild to moderate essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate and must sign informed consent form
* Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)
* Average DBP measured by 24-hour ambulatory blood pressure monitoring (ABPM) ≥80 mmHg

Exclusion Criteria:

* Secondary hypertension and malignant hypertension
* Pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures
* Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal complications
* Have following complications: cerebrovascular accident within 6 months, myocardial infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina, A-V block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other malignant arrhythmia
* Clinical significant diseases of heart, lung, liver, kidney and hematologic system or malignant tumors, HIV infection, uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥7.8 mmol/L)
* Kock pouch
* Sever gastrointestinal stenosis
* Abnormal laboratory values with clinical significance, including serum potassium \<3.5 or \>5.5 mmol/L, glutamic-pyruvic transaminase (ALT) or glutamic oxalacetic transaminase (AST) \>2-fold upper limit of normal (ULN), Cr \>ULN
* Uric acid \>ULN with the diagnosis of gout
* Gastrointestinal abnormalities or surgery that may interfere with drug absorption
* Hyperthyroidism or hypothyroidism
* Allergic to any ingredient or metabolite of investigational drug or drugs of similar structure
* Heavy smokers (\>25 cigarettes every day), alcoholics (\>250 ml liquor every day), drug addicts
* Psychological diseases, acrasia, cannot express explicitly
* Patients whose mood may be affected by variations in blood pressure, which in turn increases blood pressure
* Anxiety disorders, depression or cannot follow study protocol
* BMI \>30
* Night shift, irregular sleep patterns or insomnia
* participate in other clinical trials within 3 months
* other conditions that investigators consider unsuitable for participation
Consistency of Traditional Chinese Medicine Diagnoses and Herbal Prescriptions for Rheumatoid Arthritis

Practitioners of Traditional Chinese Medicine (TCM) make diagnoses based solely on clinical symptoms. This study will evaluate whether TCM practitioners make diagnoses consistently.

TCM is one of the oldest and most widely-used indigenous medical systems in the world. It is difficult to effectively practice or evaluate TCM outside of its core framework, which includes a diagnostic system that is more conceptual and less technologically driven than that of conventional medicine. TCM diagnosis relies entirely on clinical symptoms and signs that are discerned by the practitioner. The establishment of diagnostic and prescriptive consistency is crucial for efficacy studies involving individualized treatments within the TCM framework. This study will examine the consistency of TCM diagnoses and herbal prescriptions under controlled conditions.

Rheumatoid arthritis (RA) patients will be individually evaluated by three TCM practitioners; the diagnostic and prescriptive behaviors of the practitioners will be recorded and analyzed to determine: 1) the extent to which two or more TCM practitioners assign comparable TCM diagnoses to the same RA patients; 2) the extent to which two or more TCM practitioners prescribe comparable herbal formulas to the same RA patients; and 3) the extent to which TCM diagnoses are related to conventional clinical assessments and biomedical tests of RA. Variables that cause inconsistency will be identified and analyzed.

Eligibility Criteria:
Inclusion Criteria

* Rheumatoid arthritis
Effectiveness of an Interventional Intervention in Improving the Work Environment of Nurses and Nursing Assistants in the Hospital

The goal of this interventional study is to evaluate the effectiveness of a training course on a healthy work environment for nurses and nursing assistants in a hospital. The main questions it aims to answer are:

* To evaluate the effectiveness of a training course on a healthy work environment
* To know the perception of nursing and nursing assistants on what is needed to have a healthy work environment, what elements it should contain and whether it has changed after the course has been completed

Participants in the intervention group will receive the training course and the control group will not. Researchers will compare intervention group with control group to see if the training course on healthy work environment is effective.

Concurrent mixed study consisting of different phases in which the qualitative and quantitative parts will be interspersed. The qualitative part will include focus groups, and the quantitative part will be a controlled non-randomised experimental study by convenience sampling according to hospital unit and professional category (nurses and nursing assistants). Multicenter study carried out at Hospital General de Granollers and the Consorci Sanitari de Terrassa in nursing professionals and nursing assistants with one year of experience working in the hospital in any of the hospitalization services or special services. Once the subjects have been included in the study, they will be assigned in each group (control group and intervention group) through a stratification by quotas following the same criteria as in the sampling. The intervention group will receive training (n=56), and the control group will not (n=112). The training will be based on the American Association of Critical Care Nurses standards on a healthy work environment. In both groups, the same data will be collected at different times (before and just after the training, at 6 months and 12 months post-training). The focus groups will not be conducted in the control group after the training. Work environment, burnout, intention to leave the job and staff engagement will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary acceptance to participate in the study
* Having worked at least one year in the hospital

Exclusion Criteria:

* Nursing supervisors/nursing assistants or people with management positions
* Professionals working in more than one care center
* Professionals working in the outpatient area
Avalglucosidase Alfa Pregnancy Study

This is a worldwide, descriptive safety study collecting data on women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation, to assess the risks of avalglucsodiase alfa on pregnancy and maternal complications and adverse effects in the developing fetus, neonate, and infant.

* Outcomes in exposed infants, including growth and development, will be assessed through at least the first year of life.
* Data will be collected for approximately 10 years.

Study Design Time Perspective: Retrospective and Prospective

Eligibility Criteria:
Inclusion Criteria:

* Women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation for whom an Individual Case Safety Report (ICSR) has been submitted to the Sanofi Global Pharmacovigilance (PV) department, and/or,
* Women exposed to avalglucosidase alfa during pregnancy and/or lactation who have provided informed consent to enroll in the Pompe Pregnancy Sub-registry.

Exclusion Criteria:

There are no exclusion criteria in this study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia

Determination of FH status by genetic testing in school age children who have demonstrated elevated cholesterol on baseline screening.


Eligibility Criteria:
Inclusion Criteria:

Elevated cholesterol on baseline screening to use as means of identifying those with an FH variant

Exclusion Criteria:

* normal cholesterol
Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.

The purpose of this study is to compare the feasibility, safety and efficacy of hemodialysis with unfractionated heparin compared to hemodialysis with Citrasate in Critically Ill Patients.

Objective : To compare the feasibility, safety and efficacy of Sustained Low Efficiency Daily Hemodialysis (SLEDD) using regional anticoagulation with Citrasate® compared to systemic anticoagulation with unfractionated heparin in critically ill patients.

Design : Prospective, randomized, single-center clinical trial Setting : mixed medical-surgical 45 bed ICU in a tertiary university hospital Patients : 250 patients with Acute Kidney Injury (AKI) stage III needing renal replacement therapy Interventions : Patients are randomized to receive SLEDD using standard dialysate and systemic anticoagulation with UF versus SLEDD using Citrasate®-dialysate with no additional UF.

Measurements and main results :

Primary end point :

- The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.

Secondary end points :

* The incidence of bleeding episodes as defined by the WHO-criteria
* The transfusion requirements
* The incidence of technique failure
* The incidence of metabolic derangements (metabolic alkalosis, metabolic acidosis, hypocalcemia, hypercalcemia, hypernatremia, hyponatremia)
* The incidence of citrate intoxication
* The dialysis efficiency expressed as Kt/V and URR

Tertiary end points :

- All cause mortality at day 28 and day 90 after inclusion

Eligibility Criteria:
Inclusion Criteria:

* Need for hemodialysis in the ICU for at least one treatment
* No prior hemodialysis treatment in the ICU except continuous renal replacement therapy

Exclusion Criteria:

* Need for systemic anticoagulation with unfractionated or fractionated heparin, oral anticoagulants or intravenous anti-aggregants for other reasons
* Need for continued thrombolysis therapy within the 6 hours before inclusion
* Need for continued treatment with activated protein C (drotrecogin alfa) within the 12 hours before inclusion
* Need for continued treatment with intravenous anti-aggregants (abciximab, eptifabide) within 12 hours before inclusion
* Liver failure (acute and acute-on-chronic)
* Confirmed or suspected Heparin Induced Thrombocytopenia (HIT)
* Heparin allergies
* Severe uncorrected hypocalcemia (ionized calcium \< 0,8 mmol/l)
* Refusal of informed consent
Microbiology of Severe Acute Tonsillitis, Peritonsillar Cellulitis, and Infectious Mononucleosis

Prospective, observational study of the microbiology of patients referred to a tertiary care center with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis.

Patients referred to tertiary care centers with acute throat infections are most often treated with antibiotics. However, very little is know concerning the prevalent pathogens in patients with acute throat infections without abscess formation. Evidence suggests that Fusobacterium necrophorum plays an important role in complications of acute tonsillitis (e.g. peritonsillar abscess), but also uncomplicated acute tonsillitis.

This study aims to explore the throat microbiology of patients with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis with a special attention to a possible role of Fusobacterium necrophorum.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred to our tertiary care center with acute tonsillitis with or without signs of peritonsillar cellulitis and with or without infectious mononucleosis.
2. Center Score 3 or 4.

Exclusion Criteria:

1. Abscess formation.
2. Previous tonsillectomy.
Iron Deficiency Anemia in Childern With Liver Cirrhosis

Iron deficiency anemia is a common complication of liver cirrhosis in childern and may affects there life this study to improve the outcome of these patients

Patients with cirrhosis are at risk of developing both IDA and anemia of chronic disease concomitantly, and there adverse effects can deteriorate general condition and affect of quality of life in these patients .Also because it is easier to correct IDA than anemia of chronic disease, so this study of the prevalence of IDA helping us in the diagnosis and treatment of IDA and can reduce the need for other diagnostic tests and improve the quality of life in patients with cirrhosis .

Eligibility Criteria:
Inclusion Criteria:

* all childern with liver cirrhosis in GIT and hepatology unit

Exclusion Criteria:

* Neonates less than one month
* childern with other liver diseases
A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in Chinese participants with radiographic axial spondyloarthritis (r-axSpA).


Eligibility Criteria:
Inclusion Criteria:

* Have an established diagnosis of radiographic axial spondyloarthritis (r-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
* Participants have a history of back pain ≥3 months with age at onset \<45 years.
* Biologic naïve or have had prior treatment with 1 tumor necrosis factor (TNF) inhibitor.
* Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
* Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

Exclusion Criteria:

* Have total ankylosis of the spine.
* Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
* Have an ongoing or serious infection within the last 12 weeks.
* Have a compromised immune system.
* Have any other serious and/or uncontrolled diseases.
* Have either a current diagnosis or a recent history of malignant disease.
* Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
* Are pregnant or breastfeeding.