cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effectiveness of Vaccination With 2009 H1N1 Vaccines During Influenza Season 2010-11

A cohort of 3000 adults is followed to evaluate the effectiveness of the monovalent 2009 H1N1 vaccines used 2009-2010 and seasonal influenza vaccines used 2010-2011 in preventing the first laboratory-confirmed 2009 H1N1 influenza during the influenza season 2010-11.

In the beginning of the study, changes in the background information collected in the original study (conducted 2009-2010) are asked with a questionnaire. Information on influenza vaccinations is collected with vaccination cards and monthly short message service (SMS), and verified in registers, if needed. If an epidemic caused by the 2009 H1N1 virus starts in Finland, the participants are asked to actively report symptoms of influenza like illnesses (ILI). The symptoms are also monitored by weekly SMS. In case of ILI, nasal and oral swabs are collected to verify the 2009 H1N1 influenza cases. Paired serum samples are collected at the acute on convalescence phase of the disease. The occurrence of laboratory-confirmed 2009 H1N1 influenza cases is compared between vaccinated and not (yet) vaccinated persons.

Eligibility Criteria:
Inclusion criteria for the interview follow-up:

* Participating in the study "Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study" (AH1N1-483-09THL)
* Assigned to use the services of Tampere health care centre;
* Written consent for the interview follow-up phase obtained by mail;
* Able to adhere to all protocol-required study procedures without any special burden or risk, as judged by the participant himself/herself

Inclusion criteria for the confirmation of 2009 H1N1 influenza cases:

* Participating in the study interview follow-up of the current study 'Evaluation the effectiveness of vaccination with 2009 H1N1 vaccines during influenza season 2010-11 (H1N1-495-10THL)
* Assigned to use the services of Tampere health care centre
* Written informed consent for the confirmation phase obtained at the first study visit
* Able to adhere to all protocol required study procedures without any special burden or risk, as judged by the investigator or designate

Exclusion criteria:

* No specific exclusion criteria will be applied
Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis

Primary Objective:

To assess the safety and tolerability of a single dose of subcutaneously administered sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant treatment with methotrexate.

Secondary Objective:

To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in Japanese RA patients.

Total study duration per patient is up to 88 days

1. Screening: 3 to 28 days
2. Treatment: 1 day
3. Follow-up: 57± 3 days after dosing

Eligibility Criteria:
Inclusion criteria:

1. Male or female Japanese who are 20 to 65 years of age
2. Diagnosis of rheumatoid arthritis (RA) ≥ 3 months duration
3. Treated for a minimum of 8 weeks with Methotrexate (MTX) and with a stable dose of MTX (6-16 mg/week) for a minimum of 4 weeks prior to the screening visit

Exclusion criteria:

1. Autoimmune or inflammatory systemic or localized joint disease other than RA
2. Women of a positive pregnancy test
3. Latent or active tuberculosis
4. Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist
5. Treatment with anti-TNF agents, as follows:

   1. Etanercept: within 28 days prior to randomization
   2. Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to randomization
6. Received any live, attenuated vaccine within 3 months prior to the randomization visit (eg, varicella-zoster, oral polio, rubella vaccines)
7. Significant concomitant illness such as, but not limited to, cardiovascular, renal, neurological, endocrinological, gastrointestinal, hepato-biliary, metabolic, pulmonary or lymphatic disease that would adversely affect the patient's participation in the study.
8. Received surgery within 4 weeks prior to the screening visit or planned surgery during the study
9. History of a systemic hypersensitivity reaction

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Developpement of 3T MRI Protocol

Since January 2010, a new magnetic resonance imaging scanner (Philips 3T, Achieva) is installed on the Baudot Building in Toulouse hospital. This tool, is completely dedicated to the research. It was installed with sequences RMN supplied by the manufacturer.

Imagers also contain an instrumentation susceptible to evolution and/or to adjustment (antennas radio frequency, sheath of gradients, elements of physiological monitoring (for example control of the breath), regulation of the homogeneity of the magnetic field).

This MRI scanner and this instrumentation are used for anatomical examinations or for paradigms of cognitiveresearch (for example of detection of intellectual activations following simple stimuli of fingers movement, visual tasks, or of mental processes).

The developpement of this equipment is going to favor the emergence of numerous projects and new themes, up to there adressed by other techniques (psychophysics, EEG).

To obtain good quality signals and know the practical limits of this imager, it is thus necessary that the researchers doctors, physicists and engineers, can finalize on volunteers' significant number, all the sequences RMN necessary for the use of these tools for the research.

These developments are going to get organized around four main axes:

1 the control of the geometrical distortions (generated by the introduction of an object within the magnetic field) 2 Optimization of the parameters of sequences to improve the contrast and the spatial resolution of the obtained images 3 the development of new sequences 4 the feasibility study of the protocols of functional MRI


Eligibility Criteria:
Inclusion Criteria:

Healthy adult, age = 18 years;

* Visual, hearing , oral or written capacities and expression sufficient for the suitable realization of the tests;
* Obtaining of the informed consent of the subject.

Exclusion Criteria:

* Subjects presenting a neurological, psychiatric history;
* Subjects under chronic medication which can influence the intellectual activity;
* Subjects presenting a contraindication to the MRI (carriers of a pacemaker, an implanted material(equipment) activated by an electric, magnetic or mechanical system, carriers of haemostatic clips of anévrysmes intracérébraux or carotid arteries, carriers of orthopaedic, claustrophobic implants);
* Subjects refusing to be informed about the possible presence of an anatomical anormality;
* administrative Problems: impossibility to give about the information, no insurance, refusal to sign the consent, under guardianship subject ;
* Subjects participating in another protocol • pregnancy
Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain

A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in pre-menopausal women.

This is a Phase 3 multicenter, double blind randomized study to assess the continued safety and efficacy of the 150 mg once daily (QD) and 200 mg twice daily (BID) doses of elagolix in premenopausal women with moderate to severe endometriosis-associated pain who completed the 6 month treatment period in the pivotal study M12-665 (NCT01620528). The study consists of 2 periods: a 6 month Treatment Period and a post treatment follow-up period of up to 12 months.

Participants who received elagolix in the pivotal study who met all entry criteria continued to receive the same dose, either elagolix 150 mg QD or elagolix 200 mg BID for up to an additional 6 months in this extension study; participants who received placebo in the pivotal study were randomized in a 1:1 ratio to receive either elagolix 150 mg QD or elagolix 200 mg BID for up to 6 months.

An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis associated pain on a daily basis.

All participants who prematurely discontinued treatment (unless pregnant or elected surgery for endometriosis) or completed the 6-month Treatment Period in this extension study were to enter the Post-treatment Follow-up (PTFU) Period within this study for up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528)
* Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period

Exclusion Criteria:

* Clinically significant gynecological condition
* Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip
* Plans to become pregnant in the next 18 months
Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes
* Eye pressure lowering topical medications are not working
* Visual acuity is at least 0.2 in each eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Any other active eye disease other than glaucoma or ocular hypertension
* Significant visual field loss or evidence of progressive visual field loss within the last year
* Anticipated wearing of contact lenses during the study
* Required chronic use of other ocular medications during the study
* Eye surgery or laser treatment within 12 weeks prior to study enrollment
Physiotherapy Applications in Upper Extremity Lipedema

Lipedema which causes excessive accumulation of fat in the subcutaneous tissue, is a rare, progressive disease. This disease generally affects women, following puberty or early adulthood and usually results in the slow increase of the circumference of the legs and/or arms, bilaterally. In a typical presentation of lipedema, the enlargement of the lower extremities is disproportionately greater than that of the trunk and upper extremities When first described in 1940, lipedema was thought to exclusively affect the lower extremities. However, as the disease has been recognized over the years, lipedema has been reported to affect the upper extremities. Upper extremity lipedema, with no involvement of the lower extremities is an extremely rare incident.

Due to the hypertrophy in adipose tissue, the link between lymphatic dysfunction and the progression to lipo-lymphedema, lipedema is conservatively treated with physiotherapy, manual lymph drainage and compression, also known as complex decongestive physiotherapy. Furthermore, the consensus of the International Society of Lymphology has stated that intermittent pneumatic compression is an optional treatment which may be applied as an adjuvant therapy to complex decongestive physiotherapy. All participants included in the study were included in a treatment protocol consisting of complex decongestive physiotherapy and intermittent pneumatic compression. The Perometer was used in the measurement of upper extremity volume and circumference before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 18-65,
* having a diagnosis of upper extremity lipedema
* being willing to participate in the study

Exclusion Criteria:

* accompanying diagnosis of lymphedema,
* deep vein thrombosis
* disease which causes edema in the upper extremities
Fiber and Water Improve Bowel Habit in Humans

Twenty healthy volunteers had their baseline parameters (symptoms, bowel habit, quality of life, fecal characteristics and microbiota) measured during a week of monitoring followed by randomization to a 14 days course of increased fiber in diet or increased fiber and water intake, with repetition of parameters measuring at the end.

Demographic and clinical data were collected and recorded in the first interview after signing the informed consent. The protocol was composed of two phases. The baseline phase lasted 7 days, when participants reported their usual diet on a food dairy in the first 3 days, between Sunday and Tuesday. Calculation of nutrient intake was performed using ADS nutri software (UFPEL, Pelotas, Brazil). Participants approved for the next phase were then randomized to fiber and fiber+water groups, which lasted 14 days. During this period participants were asked to report their intestinal habits including bowel movements, graduation of straining and subjective stool consistency. Participants were instructed to rank straining using a Likert scale from 1 (minimum) to 5 (maximum), and the Bristol scale for stool consistency. In the last day of treatment phase (Saturday) participants collected feces and urine of 24 hours, and responded a symptoms questionnaire. Food and liquid intake were recorded on a diary during the last 3 days of treatment for comparison with the baseline phase stage.

Eligibility Criteria:
Inclusion Criteria:

* non-obese
* absence of abdominal complaints

Exclusion Criteria:

* use of medications that interfere with the gastrointestinal tract function
* past of abdominal surgery
* any acute or chronic disease
A Study of Improving Education of Community Chain of Survival

"High-quality cardiopulmonary resuscitation (CPR)" and "early defibrillation" are the most important parts of "the chain of survival", and they are highly associated with the survival rate and life quality of patients with cardiac arrest. It needs the witness to perform bystander CPR and use the automated external defibrillator (AED) if CPR and defibrillation are expected to be performed earlier. Nevertheless, few patients with cardiac arrest received bystander CPR in Taiwan. It might be caused by some reasons. First, traditional training programs were inefficient and ineffective in the retention of skills and thus students were not confident in their CPR skills after receiving training programs. Second, the current training module focused on personal skill training only and lacked teamwork skills training. It led to poor performance of the students in actual resuscitation scene, where on-scene resuscitators were usually more than one. Third, the current training contents did not improve the attitudes and willingness of performing bystander CPR and it caused people who had received training program did not resuscitate the patients finally. To improve the above-mentioned problem, a three-year research project will be implemented. The aims of the project are the following:

1. to explore the effect of different teaching contents and hand-on practice feedback methods on the students' performance of chest compressing, ventilating and using AED in the CPR and AED training courses.
2. to analyze the current situation of teamwork when CPR and AED were performed, to build up the collaborating module accordingly and evaluate the effect of the new module on the students' performance of chest compressing, ventilating and using AED after the module is introduced into the training course.
3. to understand the factors affecting the motivations and willingness of people to learn and practice CPR and AED by utilizing questionnaires, and then to evaluate the effect of the creative program, which was modified according to the results of the questionnaires, on the motivations and willingness of people to learn and practice CPR and AED.

The investigators expect to design a more efficient resuscitation skill training course by implementing the research project and further to improve the motivations and willingness of people to learn and practice CPR and AED in the future.


Eligibility Criteria:
Inclusion Criteria:

* healthy laypersons without CPR training within two years

Exclusion Criteria:

* non
Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.


Eligibility Criteria:
Inclusion criteria:

* Early and advanced idiopathic Parkinson's disease
* Male and female patients over 18 years of age
* Indication for treatment with pramipexole ER according to Summary of Product Characteristics (SmPC)

Exclusion criteria:

* Ongoing treatment with pramipexole ER
* Exclusion criteria in line with the pramipexole ER SmPC:

In particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the SmPC.
Welfare Benefits in Functional Somatic Disorders

The objective of this observational study is to estimate the number of weeks of welfare benefits, i.e. sickness benefit, unemployment benefit and social assistance, for individuals with functional somatic disorders and compare them to

1. healthy individuals, and
2. individuals with severe physical disease.

Functional somatic disorders (FSD) are common conditions characterized by persistent patterns of physical symptoms that cannot be better explained by other physical or mental conditions (1). The conditions may cause severe impairment for the patients who present with reduced physical and mental health, lower social status, and poor labour market association (2-4).

In 2005, it was estimated that FSD accounted for 3% of hospitalizations and 10-20% of health care expenses in Denmark (5), and a newer Danish primary care study has shown patients with FSD to have higher annual health care costs compared with conventionally-defined conditions (6). In other countries, studies in clinical samples have shown increased direct and indirect health care costs of FSD (7, 8) showing a dose-response relationship with severity of the FSD (9). These studies into highly selected clinical samples may induce high risk of selection bias, and studies including random selected general population samples are therefore needed. One Canadian population-based study on health care costs of children, adolescents, and young adults with FSD also found increased health care use and costs for this group (10). Studies investigating the socioeconomic burden in terms of welfare benefits of FSD in an adult random sample from the general population are, however, lacking.

Objective To estimate the number of weeks of welfare benefits, i.e. sickness benefit, unemployment benefit and social assistance, for individuals with FSD and compare them to individuals without FSD and individuals with severe physical disease.

Eligibility Criteria:
Inclusion Criteria:

* None

Exclusion Criteria:

* Not born in Denmark
* Not being a Danish citizen
* Pregnancy
Lower Extremity Outcome Measures in SCI

Lower extremity (LE) function of patients with a spinal cord injury (SCI) will be assessed in an observational project with a cross-sectional and a longitudinal study design. The main goal is to identify kinematic and kinetic parameters to precisely characterize LE function and in parallel the impairment and limitation in SCI patients throughout rehabilitation in acute patients and in chronic patients to define LE function and LE recovery.


Eligibility Criteria:
Inclusion Criteria - Patients:

* Age 18-80
* Written informed consent
* General consent
* Spinal cord injury (SCI)
* ASIA A-D injury with lowest extent of lesion between C1 and Th12
* Mini-Mental stat examintation score \> 26

Exclusion Criteria - Patients:

* Inability to undertake any component of the trial protocol
* Clinically significant conditions such as severe cardiovascular, pulmonary or malignant disease
* Pure cauda equina i.e. peripheral nerve injury

Inclusion Criteria - Healthy controls:

* Age 18-80
* Written informed consent
* General consent

Exclusion Criteria - Healthy controls:

* Reliance on walking aids / prostheses for mobilisation
* Orthopaedic diagnosis with potential impact on gait
* Previous operations on the lower limbs or spine with potential impact on gait
* Inabilitay to undertake any component of the trial protocol
* Clinically significant conditions such as severe cardiovascular, pulmonary or malignant disease
A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer

This descriptive cross sectional study aims to directly compare the diagnostic capability of the probed-based confocal laser endomicroscopy (pCLE) and the magnifying narrow band imaging (M-NBI) in the Lugol's voiding lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age over 20 years
* Having histological-confirmed diagnosis of head and neck cancer
* Having no esophageal symptoms

Exclusion Criteria:

* Having index cancer of nasopharynx
* History of esophageal surgery
* Having esophageal stricture or obstruction
* Having esophageal varices
* Known case of esophageal cancer
* Uncorrectable coagulopathy and thrombocytopenia
* Pregnancy
* Thyrotoxicosis
* Creatinine clearance less than 30 ml/min
* Allergy to iodine or fluorescein.
Different Crystalloids on AKI in Shock

The goal is to observe that the incidence of acute kidney injury in patients who need fluid resuscitation when resuscitated with saline or acetated Ringer's sodium.

Fluid resuscitation is important to shock patients. Saline is the classical fluids for resuscitation. However, studies showed that resuscitation with saline could increase the incidence of hyperchloremia and acute kidney injury. Thus, the goal is to observe that the incidence of acute kidney injury in patients who need fluid resuscitation when resuscitated with saline or acetated Ringer's sodium.

Eligibility Criteria:
Inclusion Criteria:

* Shock patients who need fluid resuscitation with risk factors of acute kidney injury

Exclusion Criteria:

* Patients with a history of chronic kidney injury and hemodialysis therapy