cyrilzakka/clinical-trials huggingface dataset:
Non-Interventional Study Among Users Of LoFric Origo

Primary objective: To evaluate compliance of LoFric Origo in a general intermittent catheterization (IC) population with the use of LoFric Origo, by means of a subjective assessment scale

Secondary objectives:

* To evaluate the subject's perception associated with the use of the LoFric Origo, by means of a subjective assessment scale
* To evaluate the subject's discomfort associated with the use of the LoFric Origo, by means of a subjective assessment scale
* To observe and collect data on bladder regimen/IC frequency by assessments of descriptive data of demography, catheter therapy, history and other patient reported outcomes.

Study Design: Non-interventional study, multicentre, prospective study. Target Subject Population: General intermittent catheterization, LoFric Origo male users.

Medical Device: LoFric Origo

Study Variable(s):

* Primary variable: Use or No use of LoFric Origo after 8 weeks.
* Secondary variable(s): patient reported questionnaire with regards to perception, discomfort, diagnose, health status, catheter history and other patient reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent.
2. Males, aged 18 years and over
3. Practice intermittent self-catheterization, at least one time daily
4. Subjects using LoFric Origo
5. Able to read and fill out a patient reported questionnaire as judge by the investigator
6. The prescription of/decision to use the medical device is separated from the decision to include the subject in the study.

Exclusion Criteria

1. Simultaneous participation in any interfering clinical study
2. On-going, symptomatic urinary tract infection (UTI) at enrolment as judged by the investigator
3. Involvement in the planning and/or conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
4. Previous enrolment in the present study.
An Extension Study of WA19926 of the Long-Term Safety of Tocilizumab (RoActemra/Actemra) in Patients With Early Moderate to Severe Rheumatoid Arthritis

This open-label, single arm, multicenter long-term extension study of WA19926 evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who completed the 104-week WA19926 core study. Eligible patients received tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Participants who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
* No current or recent adverse event or laboratory finding preventing the use of the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
* Women of childbearing potential must agree to use adequate contraception as defined by protocol during the treatment period

Exclusion Criteria:

* Pregnant females
* Participants who have withdrawn prematurely from the WA19926 core study for any reason
* Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926
* Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926
* Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926
* Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
* Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
* Evidence of severe uncontrolled concomitant disease or disorder
* Known active or history of recurrent infections
* Active tuberculosis requiring treatment in the previous 3 years
* History of alcohol, drug or chemical abuse since inclusion in the WA19926 study
Renal Function in Patients Submitted to Myocardial Revascularization Surgery

Acute renal insufficiency (ARI) represents a frequent and serious complication in patients submitted to cardiac surgery, and is associated with increases in time of hospitalization, costs, morbidity and mortality. Its incidence varies from 3.5% to 31%. The present study aims to evaluate renal function and oxidative stress in patients submitted to revascularization surgery with extracorporeal circulation (ECC), comparing targeted venous anesthesia controlled with propofol and inhalational anesthesia with isoflurane.

Acute renal insufficiency (ARI) represents a frequent and serious complication in patients submitted to cardiac surgery, and is associated with increases in time of hospitalization, costs, morbidity and mortality. Its incidence varies from 3.5% to 31%. The present study aims to evaluate renal function and oxidative stress in patients submitted to revascularization surgery with ECC, comparing targeted venous anesthesia controlled with propofol and inhalational anesthesia with isoflurane.The study will be conducted at the Botucatu Medical School (FMB) and will analyze 60 patients, divided into two randomized groups, submitted to revascularization surgery of the myocardium with ECC. The researcher responsible for data collection from patients will not have knowledge of the type of anesthesia being delivered to the patient.Blood samples will be collected by central venous access for dosing of troponin I, troponin T, CKMB, MDA, creatinine, urea, albumin and cystatin C.Renal function will be evaluated by serum cystatin C and creatinine and the estimated glomerular filtration rate (GFR). GFR will be measured by means of serum cystatin C (Larsson's formula) and by serum creatinine through the Cockcroft-Gault formula (CG) and by the MDRD formula (Modification of Diet in Renal Disease).Markers of renal tubular function will be dosed in the urine, including: alkaline phosphatase, γ - glutamyltransferase(γ-GT), β 2 microglobulin, creatinine and urinary cystatin C.

Eligibility Criteria:
Inclusion Criteria:

* both sexes,
* aged from 18 to 75 years,
* submitted to revascularization surgery of the myocardium
* extracorporeal circulation,
* who had consented to participation by signing the Terms of Free and Clear Consent.

Exclusion Criteria:

* history of hepatic or renal dysfunction,
* history involving acute myocardial infarct
* patients that made use of vitamin C and E;
* patients presenting other cardiac pathologies (valvular, congenital, corrected or not in the same operational act).
Physical Training and Blood Pressure in High Risk Youths

To determine the effects of physical activity on blood pressure and body fat in children varying in ethnicity, gender, and health status.

DESIGN NARRATIVE:

There were two specific aims. The first was to test the hypothesis that controlled physical training (PT) reduced blood pressure, at rest and in reaction to forehead cold and exercise stressors, in 8-9 year olds who were high in both blood pressure and body fatness. Subjects were divided equally on gender and blood pressure and body fatness. Subjects were divided equally on gender and ethnicity (black/white). Both resting and reactive blood pressure were correlated with left ventricular mass and were predictive of future essential hypertension. The underlying hemodynamic regulators of blood pressure, cardiac output and the total peripheral resistance, were measured with impedance cardiography to explore hemodynamic mechanisms through which training had a favorable influence on blood pressure and left ventricular mass.

The second aim tested the hypothesis that physical training reduced percent body fat, as measured with dual energy x-ray absorptiometry (DEXA). Children above the 70th percentile in both blood pressure and fatness were randomly assigned, within ethnicity and gender, to a physical training or waiting list control group. After the physical training group underwent four months of training, all subjects were retested and these data were used to test the primary hypotheses. The initial control subjects then performed four months of physical training, after which they were retested. The data from this second phase were added to the data of the initial physical training group to explore interactions of training with gender and ethnicity. The initial physical training group was brought back four months after cessation of training to see if the changes elicited by the training were reversible. To document the stimulation provided by the training, heart rate was monitored during training sessions. To observe the time course of changes between the full lab testing sessions, skinfolds and resting blood pressure were measured monthly. Diet and free living physical activity were assessed to help explain changes in body composition. Aerobic fitness was measured with treadmill tests of maximal oxygen consumption.

Eligibility Criteria:
No eligibility criteria
A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma

To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease to irinotecan-based chemotherapy and who have failed (progressive disease or intolerance) previous oxaliplatin-based and fluoropyrimidine-based chemotherapies.


Eligibility Criteria:
Inclusion Criteria:

* The subject must have surgically unresectable metastatic colorectal carcinoma.
* The subjects who have received and failed Ilinotecan, oxaliplatin and fluoropyrimidine-based chemotherapy
* ECOG PS 0-2

Exclusion Criteria:

* Subjects with symptomatic cerebral metastasis
Registry for Chronic Venous Disease Incidence and Natural Course

A prospective cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development of chronic lower limb vein disease.

Multicenter prospective cohort observational study based on a termless epidemiological registry.

Periodic inspection and collection of data from the subjects is carried out annually, in the last quarter of the current year.

Patient data is recorded in a promising digital database and is constantly updated.

Eligibility Criteria:
Inclusion Criteria:

* A family members of the researcher (spouse, childrens, brothers and sisters, parents) or the researcher himself
* The possibility of annual clinical and ultrasound assessment of the venous system of the observed individuals

Exclusion Criteria:

* Any invasive treatment of the chronic venous disorder in anamnesis
* Venous thrombosis in the anamnesis or at the time of inclusion
Back School for Non-specific Low Back Pain (LBP) in an Urban Setting

This study will be a comparative design between 2 groups of subjects attending classes on back education in an urban setting. Participants will be randomized to either an individual one-on-one back school session or to the 8 group sessions.


Eligibility Criteria:
Inclusion Criteria:

* Participants 18 years of age or older who have been suffering from non-specific LBP for at least 3 months

Exclusion Criteria:

* Additional impairments contraindicating their safe participation in the back school program, such as evidence of spinal cord pathology, cauda equina, progressive neurological damage, infection, inflammation, malignancy, fracture or a progressive, neurodegenerative disease as well as back surgery within the past year
Prevalence of Obstructive Sleep Apnoea (OSA) Among 4-8 Years Old Children in the General Population

The purpose of this study is to estimated prevalence of obstructive sleep apnea (OSA) in 4-8 year old children. To date, most studies estimating prevalence of sleep apnea in young children are based on utilizing subjective questionnaires. The few studies that have utilized objective sleep measures have tested only those children suspected of sleep apnea based on subjective questionnaires, finding prevalence in the range of 1-13%. Untreated OSA is associated with significant morbidities in children, affecting their behavior, cognitive development, cardiovascular-and cardio metabolic health, endocrine and immune function. Better understanding of prevalence of sleep apnea in young children should be beneficial. This study will help to understand the prevalence of sleep apnea in each age-group of children 4-8 years of age and whether certain groups, such as children with obesity or asthma have higher prevalence and/or more severe disease.

The primary objective of this study is to get better understanding of prevalence and severity of sleep apnea in young children using objective sleep measures for all participants.

The study is a population-based, observational study of 4-8 year old children located in Akureyri, Iceland. All parents in this geographical area will be invited for their child/children to participate in the study.

Parents of all participating children will be asked to answer questionnaires to assess general health, sleep habits, behavior and quality of life and then measure their sleep for five consecutive nights with a home based sleep test.

Eligibility Criteria:
Inclusion Criteria:

* Children 4-8-years old

Exclusion Criteria:

* Children with atrial fibrillation or ventricular trigemini
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)

This investigation is to evaluate the performance, comfort and ease of use of the Toffee full face and toffee nasal mask masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.

Up to 20 OHS patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a F\&P Toffee Full face (if they are existing full face users) or F\&P Toffee Nasal (if they are existing nasal users) for an overnight polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18+
* Diagnosed with OHS by a practicing physician
* Existing full face mask user or a nasal mask user
* Prescribed PAP therapy (Bi-Level or CPAP)

Exclusion Criteria:

* Inability to give informed consent
* Pregnant or think they may be pregnant
* Anatomical or physiological conditions making PAP therapy inappropriate
* Patients requiring supplemental oxygen with their PAP device
* Patients who are in a coma or decreased level of consciousness
* Existing Toffee full face and Toffee nasal mask users
* No arterial PCO2 value from their medical records
A Trial on Efficacy and Safety of Full Dose Tenecteplase Combined With Unfractionated Heparin (UFH) or Enoxaparin in Acute Myocardial Infarction (AMI) in the Prehospital Setting

The primary objective of ASSENT 3 Plus (the same as for ASSENT 3) was to evaluate the safety and efficacy of full dose tenecteplase combined with unfractionated heparin (UFH, group A) and full dose tenecteplase combined with enoxaparin (ENOX, group B). An additional objective in ASSENT 3 Plus was to describe the different time intervals in the prehospital phase.


Eligibility Criteria:
Inclusion Criteria:

* Onset of symptoms of AMI within six hours prior to randomisation
* A 12-lead ECG with one of the following: ST-segment elevation ≥ 0.1 millivolt (mV) in two or more limb leads, or ≥ 0.2 mV in two or more contiguous precordial leads indicative of AMI, or left bundle-branch block
* Age ≥ 18
* Informed consent received

Exclusion Criteria:

* Hypertension defined as blood pressure (BP) \> 180/110 mmHg (systolic blood pressure (SBP) 180 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg) on repeated measurements during current admission prior to randomisation
* Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding seven days
* Major surgery, biopsy of a parenchymal organ, or significant trauma within two months
* Any minor head trauma and any other trauma occurring after onset of the current myocardial infarction (MI)
* Any known history of stroke or transient ischaemic attack or dementia
* Any known structural damage of the central nervous system
* Prolonged cardiopulmonary resuscitation (\> 10 min) in the previous two weeks
* Current oral anticoagulation
* Standard UFH (heparin sodium) \> 5000 international units (IU), or a subcutaneous (SC) therapeutic dose of any low molecular weight heparin (LMWH) within six hours of randomisation
* Known thrombocytopenia (prior platelet count below 100 000 cells/μL (100 x 10\*\*9/L))
* Known renal insufficiency (prior S-creatinine \> 2.5 mg % (\> 220 μmol/L) for men and 2.0 mg % (\> 175 μmol/L)) for women
* Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential had to have a negative pregnancy test, or use a medically accepted method of birth control
* Treatment with an investigational drug under another study protocol in the past seven days
* Previous enrolment in this study
* Known sensitivity to tenecteplase, tissue plasminogen activator (tPA), abciximab, heparin or LMWH
* Any other condition that the investigator felt would place the patient at increased risk if the investigational therapy was initiated (e.g. known haemorrhagic diathesis, acute pericarditis and/or subacute bacterial endocarditis, acute pancreatitis, severe hepatic dysfunction, diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions, active peptic ulceration, arterial aneurysm and known arterial/venous malformation, neoplasm with increased bleeding risk)
* Inability to follow protocol and comply with follow-up requirements
Effect of Dietary DHA Supplementation on Sperm Quality

The aim of this study is evaluated the effect of dietetic supplementation with DHA on human sperm quality, antioxidant capacity and sperm DNA damage.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of male factor.

Exclusion Criteria:

* Metabolic and genetic diseases.
* Oncological patients.
* Patients with anticoagulants treatment.
COVID-19 Risk Stratification

The investigators seek to derive and validate a clinically useful risk score for patients with Coronavirus Disease 2019 to aide clinicians in the safe discharge of patients.

The investigators a-priori plan the following analysis:

1. Derivation and Retrospective Validation.

   * Select all adult patients with a positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 beginning March 1, 2020 until approximately 1000 patients are included.
   * Use 75% of this cohort to develop a simple risk-score that prognosticates a patient's suitability for discharge (no supplemental oxygen, no intensive care unit, and no death). Use multivariable logistic regression with forward selection informed by clinical judgement to choose variables a priori that emphasizes readily available data and easy calculation for use at the point of care.
   * Use 25% of this cohort to retrospectively validate the risk-score.
2. Prospective Validation.

   * Select all adult patients with a positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 as soon as the derivation cohort in step 1 is assembled. Include approximately 250 patients.
   * Use this sample to prospectively validate the risk-score developed in part 1.

Eligibility Criteria:
Inclusion Criteria:

* Positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2
* Age 18 and older

Exclusion Criteria:

* None
A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.

This prospective, observational study will evaluate the patient-based sentinel lymph node detection rate when using the Infracyanine® (indocyanine green) dye technique in patients undergoing surgery for breast cancer.

The study will describe the demographic, clinical, and tumour characteristics of patients with breast cancer undergoing surgery.

The study will describe the characteristics of how the indocyanine green dye technique is used including the dose and volume of dye used, the number and type of injection sites used to give the dye, the equipment used to detect the dye and locate the sentinel lymph node, and whether indocyanine green is used on its own or with other dyes (blue dye and/or 99mTechnetium dye).

The study will evaluate the characteristics of sentinel lymph node biopsy procedures performed using indocyanine green dye including the number of biopsies performed, the time taken to detect the sentinel lymph node and perform the biopsy, and how many sentinel lymph nodes are detected using indocyanine green dye, blue dye, and 99mTechnetium dye.

The study will also assess the safety of using indocyanine green dye for 6 weeks following surgery.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged ≥18 years
* Undergoing breast cancer surgery with an indication for sentinel lymph node biopsy
* Receiving Infracyanine® (indocyanine green; alone or in combination with blue dye or 99mTc) for intraoperative identification of sentinel lymph node according to the Summary of Product Characteristics

Exclusion Criteria:

* Male
* Pregnant or nursing female
* Previous allergy to indocyanine green or to any excipients
* Already included in a surgical trial
* Patient opposed to collection and processing of their data
Immune Regulation in Multiple Sclerosis: MicroRNA and Antigen-Presenting Cells

MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in many human diseases. The purpose of this pilot study is to determine if microRNA expression is changed in untreated and interferon-beta-treated patients with multiple sclerosis.

MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in many human diseases. The purpose of this pilot study is to determine if microRNA expression is changed in untreated and interferon-beta-treated patients with multiple sclerosis. The expression of microRNA will be analysed in cell subsets separated from peripheral blood mononuclear cells.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 year-old healthy subjects or patients with RRMS/CIS

Exclusion Criteria:

1. Any treatment with steroids in the last 30 days prior to the blood draw or any immunosuppressive or Disease-modifying treatment (DMT) other than Glatiramer Acetate in the last 90 days
2. Presence of other disorders that may be associated with immune-deficient or autoimmune process (e.g., HIV, lymphoma, lupus) or demyelinating disease other than MS (e.g., Lyme, B12 deficiency)
3. Pregnancy
4. Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting (Expanded Disability Status Scale (EDSS) score greater than 5.5 )
Effects of Animal Assisted Activity on Biobehavioral Stress Responses of Hospitalized Children: A Randomized Control Trial

The purpose of this study is to assess the efficacy of a 10-minute therapy dog visitation (TDV) in reducing biobehavioral stress responses among hospitalized school-age children by comparing responses between TDV and non-TDV control groups.


Eligibility Criteria:
Inclusion Criteria:

* understand English
* alert and oriented to person, place, and time
* able to complete study instruments
* able to provide saliva specimens, and
* consent from parent/legal guardian, and
* assent from child.

Exclusion Criteria:

* currently taking hormone replacement, or steroidal antiinflammatory medications
* in contact precautions at facility
* diagnosed with Addison's or Cushing's disease, and
* fears, phobias, or allergies to dogs.