cyrilzakka/clinical-trials huggingface dataset:
Helsinki Ultra-acute Stroke Biomarker Study

The aim of this study is to establish diagnostic and predictive biomarkers for patients with suspected acute stroke, that are transported by EMS as candidates for thrombolytic treatment. The study focuses on the ultra acute phase, \<4.5 hours from symptom onset, including the prehospital setting. Analyses will include known biomarkers (e.g. GFAP, NR2 peptide) and a discovery phase for novel markers. Patient outcome will be evaluated at 3 month using the modified Rankin Scale (mRS).


Eligibility Criteria:
Inclusion Criteria:

* Acute stroke suspected by EMS personnel
* Transport to tertiary hospital as possible candidate for thrombolytic treatment of ischemic stroke
* Age ≥18
* Successful prehospital blood sampling by EMS personnel

Exclusion Criteria:

* Unsuccessful prehospital blood sampling by EMS personnel
A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)

This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).

Patients selected by investigator according to clinical routine

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic breast cancer

Exclusion Criteria:

* History of hypersensitivity to Caelyx or its components
* Women who are pregnant or breast-feeding
* Patients with severe myelosuppression
Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial

Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. Use of sedation during bronchoscopy has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is routinely performed at many centres including ours.

Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is limited literature on the efficacy of lignocaine delivered with the nebulized route during awake flexible bronchoscopy. This study would help to determine the utility of nebulized lignocaine in airway anaesthesia during flexible bronchoscopy.

For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to nebulized lignocaine (4%) or saline (placebo) nebulization group. Prior to the bronchoscopy blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the nebulized lignocaine. Patient, Operator, outcome assessor will be blinded to the allocation.

During the procedure, 1.5ml aliquots of 1% lignocaine will be delivered through the bronchoscope using spray-as-you go technique. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction.

Post procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.

Eligibility Criteria:
Inclusion Criteria:

* Adult (Age \> 18 years) patients undergoing diagnostic or therapeutic flexible bronchoscopy

Exclusion Criteria:

1. Pregnancy
2. Hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with Fio2 of ≥ 0.3
3. Bronchoscopy done through endotracheal or tracheostomy tube
4. Not willing to provide informed consent.
5. Patient requiring sedation for flexible bronchoscopy
6. Patients with known allergy to lignocaine -
Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma

Primary Objective:

To compare the efficacy of TACE vs. CyberKnife SBRT in the treatment of locally recurrent HCC after initial TACE.

Secondary Objectives:

1. To determine the progression-free survival of TACE vs. CyberKnife SBRT
2. To determine the overall survival of TACE vs. CyberKnife SBRT for locally recurrent HCC
3. To determine the toxicities associated with TACE or CyberKnife SBRT for the treatment of recurrent HCC.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed hepatocellular carcinoma by one of the following:

  * Histopathology
  * One radiographic technique that confirms a lesion \>=2 cm with arterial enhancement with washout on delayed phase
* Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure
* Radiographic evidence of persistent, progressive or recurrent disease in an area previously treated with TACE. This evaluation should be determined after 6 weeks of initial TACE
* Multi-specialty evaluation whereby the recurrent liver lesion was deemed by both the attending radiation oncologist and interventional radiologist amenable to treatment by the respective modality

  * Eligible patients must undergo an IV contrast CT scan of the liver within 6 weeks of enrollment onto the study; a contrast enhanced liver MRI may be substituted for the IV contrast CT of the liver.
  * A recent serum AFP must also be obtained within 4 weeks of enrollment.
* Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension. Multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 7.5cm as long as the dose constraints to normal tissue can be met
* Eastern Clinical Oncology Group performance status 0, 1 or 2
* Patients with liver disease classified as Child Pugh class A/B; if Child's class B, score must be 8 or less
* Albumin \>= 2.5 g/dL
* Total bilirubin \<= 3 mg/dL
* INR \<= 1.5
* Creatinine \<= 2.0 mg/dL
* Age \>= 18 years old
* Life expectancy\>= 6 months
* Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior radiation for the recurrent liver tumors
* Prior radiotherapy to the upper abdomen
* Prior RFA to index lesion
* Liver transplant
* Tumors \>= 7.5 cm in greatest axial dimension
* Portal vein thrombus
* Large varices within 2 cm of index lesion (seen on cross section imaging)
* Contraindication to receiving radiotherapy
* Active gastrointestinal bleed within 2 weeks of study enrollment
* Ascites refractory to medical therapy
* Women who are pregnant
* Administration of any systemic chemotherapy within the last 1 month
* Presence of multifocal lesions located in different lobes of the liver or extrahepatic metastases
* Participation in another concurrent SYSTEMIC treatment protocol
* Prior history of malignancy other than HCC
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma

This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma.

The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments.

Study details include:

* The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study.
* The investigational treatment duration will be up to approximately 52 weeks.
* The number of visits will be 18.


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.
* At least 1 asthma exacerbation in the year prior to Screening (Visit 1).
* Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative \[GLI\] standards) at Screening (Visit 1).

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Other severe lung diseases (eg, chronic obstructive pulmonary disease \[COPD\]. bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.
* Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening (Visit 1) (counting from the date of completion of treatment for asthma exacerbation).
* Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
* Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* Evidence of any infection requiring systemic anti-infective treatment within 2 weeks before Screening (Visit 1) or during the screening period. Significant viral infections within 2 weeks before Screening (Visit 1) or during the screening period even if the participant has not received systemic antiviral treatment (eg, influenza receiving only symptomatic treatment).
* Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active TB), or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).
* Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease.

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical study.
Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoprotein(a)

Lipoprotein(a) \[Lp(a)\] is an independent risk factor for cardiovascular disease. Non-medical treatment measures (e.g. dietary therapy or weight loss) can hardly influence Lp(a) plasma concentrations. Drug therapy has only limited influence, e.g. treatment with niacin. Statins are usually without effect. Lipid apheresis is the only treatment known to lower elevated Lp(a) levels in a relevant way. In patients with pronounced elevation of Lp(a) and normal LDL cholesterol levels, who suffer from progressive cardiovascular disease, the treatment with lipid apheresis seems to be a last-resort treatment option. The current trial will evaluate the effectiveness of lipid apheresis on cardioavascular endpoints.

Lipoprotein(a) \[Lp(a)\] is an independent risk factor for cardiovascular disease. Non-medical treatment measures (e.g. dietary therapy or weight loss) can hardly influence Lp(a) plasma concentrations. Drug therapy has only limited influence, e.g. treatment with niacin. Statins are usually without effect. Lipid apheresis is the only treatment known to lower elevated Lp(a) levels in a relevant way. In patients with pronounced elevation of Lp(a) and normal LDL cholesterol levels, who suffer from progressive cardiovascular disease, the treatment with lipid apheresis seems to be a last-resort treatment option. The current trial will evaluate the effectiveness of lipid apheresis on cardioavascular endpoints. The trial is a randomized multicenter trial in Germany. Patients will be randomized to the apheresis group or to the control group. All patients will receive maximal risk minimizing therapies. The apheresis group will receive in addition weekly lipid apheresis. The principal outcome parameter is a composite endpoint of non-fatal myocardial infarction, interventional therapeutic procedure (PCI, stenting), coronary bypass surgery (CABG), non-fatal ischemic cerebrovascular accident, hospitalization due to acute coronary syndrome (ACS), critical limb ischemia, peripheral arterial revascularization procedure; amputation, death from cardiovascular cause.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Male or female
* Written informed consent
* Lipoprotein(a) \>=60 mg/dL
* Low-density lipoprotein cholesterol \<130 mg/dL
* Progressive cardiovascular disease
* Positive recommendation by the Inclusion Committee

Exclusion Criteria:

* Current participation in a lipid apheresis program
* Previous participation in a lipid apheresis program
* Low-density lipoprotein cholesterol \>=130 mg/dL under maximally tolerated (or necessary) drug treatment
* Triglyceride concentrations \>=450 mg/dL
* Known homozygous familial hypercholesterolemia
* Known type III hyperlipoproteinemia
* Pregnancy, breast feeding
* History of malignant disease (with the exception of non-melanoma carcinomas of the skin and carcinoma in situ of the cervix)
* Planned major surgical procedures in the next 3 months
* Current participation in another interventional trial
* Previous randomization in the current trial (applies only for the RCT)
Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)

To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

1. Filgotinib-naïve participants with moderately or severely active UC as judged by the physician and starting filgotinib treatment according to local treatment guidelines, routine practices and product information.

Exclusion Criteria:

1. Participation in any interventional or non-interventional study without prior approval from the medical leader. This does not preclude inclusion of participants enrolled to national registries.
2. Participant is diagnosed with Crohn's disease.
Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?

Surgery performed during general anesthesia induces a stress effect on the body. Our plan is to identify population at risk of hyperglycemia during perioperative period.

This is a prospective study to define the relationship between time profile of glucose control before, during and after surgery with patient variables, surgical variables and anesthetic variables. Serum glucose levels will be measured preoperatively and then at 30 minute intervals during surgery. Pain score, pain medication and glucose levels will be measured in the post anesthesia recovery room. Subjects will be contacted 2 weeks following the date of surgery to determine the incidence of postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* 18-80 years of age

Exclusion Criteria:

* Known diabetics
* Pregnant patients
* Cardiac surgery patients
* Liver transplant patients
An Observational Study to Assess the Canagliflozin Treatment in Type 2 Diabetes Mellitus in a Usual Clinical Practice in Canada

The purpose of this study is to evaluate canagliflozin use in the treatment of type 2 diabetes mellitus (T2DM) and generate evidence of its effectiveness, safety and patient-reported outcome (PRO) in a usual clinical practice in Canada.

This is a prospective, non-interventional, nation-wide, multicenter (more than one study site) study to evaluate the treatment of T2DM with canagliflozin in a usual clinical practice in Canada. Approximately 535 participants will be enrolled into this study. The planned study duration for each participant will be 12 months \[plus or minus (+/-) 4 weeks\], including 4 study visits in accordance with the usual clinical practice: enrollment and visits at 3, 6 and 12 months (+/- 4 weeks). Participants will primarily be observed for effectiveness, safety and PRO over an observational period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Participant must have a diagnosis of type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin (HbA1c) of greater than or equal to (\>=) 7 percent (%) at baseline
* Participant must be on a stable antihyperglycemic treatment regimen for at least 30 days prior to canagliflozin initiation
* Participant must have estimated glomerular filtration rate (eGFR) \>=60 milliliter (mL)/minute(min)/1.73 meter\^2 (m\^2)
* Must be a sodium-glucose co-transporter 2 (SGLT2) inhibitors naive participant initiating canagliflozin treatment prior to study enrollment
* Participant must provide a written consent for data collection by signing an ICF indicating that they understand the procedures for data collection and are willing to participate in the study

Exclusion Criteria:

* Participants with a history of SGLT2 inhibitors use (canagliflozin, empagliflozin, dapagliflozin or any other SGLT2 inhibitor)
* Participants with a history of diabetic ketoacidosis (DKA), autoimmune diabetes (example, type 1 diabetes mellitus \[T1DM\] and latent autoimmune diabetes in adults \[LADA\]), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* Participants who received an investigational drug (including vaccines) within 3 months before the initiation of canagliflozin
* Participant who is currently enrolled or plans to enroll in an investigational study
* Participant who is pregnant or breastfeeding or planning to become pregnant or breast feed during the study
Decision Support System for Stroke Survivors

The aim of the study is to evaluate the usability of the system and its accordance with the users' needs. This evaluation will consider the effectiveness and the efficiency of the system, as well as stroke survivors' satisfaction. The effectiveness and the efficiency of the system will be measured by:

* The relationship between the control of stroke survivors' daily activities and their risk of having a secondary stroke,
* The decrease of the need for caregivers,
* And consequently an improvement in stroke survivors' self-management.

The aim of the study is to evaluate the usability of the system and its accordance with the users' needs. This evaluation will consider the effectiveness and the efficiency of the system, as well as stroke survivors' satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years.
* First ischemic stroke within the past 6 months.
* Hemiparesia with mild (91-99)-moderate (61-90) disability (Barthel Index).
* With or without speech patology but able to understand simple orders ( \>45).
* Able to cope and to understand the guidelines to use the devices.
* Informed consent signed.

Exclusion Criteria:

* Life expectancy \<12 months.
* Severe cognitive impairments.
* Medical comorbidities that could interfere with the home-rehabilitation program (MoCA \< 26).
* Socio-familiar dystocia (SFES ≥ 14).
* Modified Rankin Scale \> 1.
Annual Study for Fluarix Registration

A pre-requisite to the yearly licensing process of the Influenza vaccine (FluarixTM/ Influsplit SSW®) is to demonstrate in clinical studies, the immunogenicity and reactogenicity of the vaccine composed of the new strains (2005/2006).

Since 1998 it is common practice within the European Community, to grant new licensees for Influenza Vaccines including the actual strain composition, by realizing the EU "Mutual Recognition Procedure" The procedure foresees the clinical testing of the vaccine before approval according to the particulars in the EU-Document CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines" of the "Committee for Proprietary Medical Products (CPMP) as Sub-Organization of the "European Agency for the Evaluation of Medicinal Products". Assessment of the Immunogenicity and Reactogenicity of the in its strain composition actualized, Influenza split vaccine2004/2005 (Influenza split vaccine 2005/2006) versus the criteria of the CPMP.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return, and follow-up visits) should be enrolled in the study.
* All Subjects, enrolled in this study, must not been immunized against Influenza within the season 2003/2004.
* Written informed consent obtained from the subject must be available, after the subject has been informed in an understandable language.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature / axillary temperature \<37.5°C (99.5°F).
* Acute clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Pregnancy (exclusion by safe contraception; pregnancy test at day 0.
* Known allergic reactions, probably caused by one or more vaccine ingredients.
* Drug and/or Alcohol abusers
Pharmacotherapy for HIV Infected Patients With Alcohol Problems

This is a randomized double blind clinical trial to test the effect of Naltrexone on HIV infected heavy drinkers. The study will select 40 HIV positive patients who meet criteria for heavy drinking. Treatments include Naltrexone (25-100mg)and placebo. Patients will be treated, followed up, and assessed for a duration of 12 weeks.

The investigators associated hypotheses Hypothesis 1: Naltrexone will reduce the frequency of heavy drinking. Hypothesis 2: Naltrexone will lead to maintenance or improvement in CD4 lymphocyte count and decreased HIV RNA levels.

Hypothesis 3: Naltrexone will lead to a reduction in sexual risk behaviors. Hypothesis 4: Naltrexone will lead to improved adherence to HAART. Hypothesis 5 (Exploratory): Naltrexone will be well-tolerated with minimal side effects and patients will exhibit good treatment retention.


Eligibility Criteria:
Inclusion Criteria:

1. Be HIV-positive.
2. Report heavy drinking 4 or more times in the past 4 weeks. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on any occasion.
3. Not be abstinent from alcohol for greater than 30 days.
4. Be at least 18 years old.
5. Be able to understand English and provide informed consent

Exclusion Criteria:

1. Be psychotic or severely psychiatrically disabled.
2. Have medical conditions that would preclude completing or be of harm during the course of the study.
3. Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range) or cirrhosis.
4. Have a known contraindication to naltrexone therapy (e.g. taking opioid medication for pain).
5. Be pregnant, nursing or unable to use an effective method of birth control (women).
6. Subjects who are taking or use narcotics will not be included because naltrexone will precipitate withdrawal.