cyrilzakka/clinical-trials huggingface dataset:
Cardiac Arrest and Ventilation Method

Comparison of Manual Ventilation and Automatic Mechanical Ventilation during CPR, Pilot \& Feasibility Study (CAVE-I trial)

This is a preliminary randomized clinical trials comparing the effectiveness of the automatic mechanical ventilation method compared to manual ventilation methods commonly performed during advanced cardiac life support (ACLS) in emergency room for out-of-hospital cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest (OHCA)
* Transferred by only EMS without prehospital return of spontaneous circulation (ROSC)
* ACLS for at least 20 minutes in the emergency room
* Arterial blood gas analysis at least once during ACLS

Exclusion Criteria:

* In-hospital cardiac arrest (IHCA)
* Not transferred by Emergency Medical Service
* ROSC gained before arriving at the ER
* OHCA caused by trauma
* ACLS is not performed for more than 20 minutes because the death is obvious
* Not able to intubate the trachea
LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

The hypothesis in this study was that ticagrelor switched to 60 mg after 1 month of standard dose, with antiplatelet activity that is not inferior to the standard dose and better than 75 mg clopidogrel for patients with ACS after PCI.


Eligibility Criteria:
Inclusion Criteria:

* Agree to sign the Informed Consent;
* Male or female, ≥ 18 years of age, and ≤ 70 years of age
* Patient presents with acute coronary syndrome (ACS)
* Planned to undergo PCI
* Planned to DAPT for 1 year after PCI

Exclusion Criteria:

* Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
* Patients cannot use ticagrelor or clopidogrel due to contraindications or other reasons.
* Patients with active pathological hemorrhage or a history of intracranial hemorrhage
* Patient unable to receive 12 months of dual anti-platelet therapy
* Patient developing procedure-related complications such as stent thrombosis, coronary dissection, coronary perforation, cardiac tamponade or no-reflow during PCI
* Patient or physician refusal to enroll in the study
* History of intracranial hemorrhage
* Patient has a history of bleeding diathesis or coagulopathy
* Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding
* Patient is pregnant, breastfeeding, or planning to become pregnant within 12 months
* Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)
* Patient with cardiogenic shock or mechanical circulatory assist devices placed
* Patient with active liver diseases
* Patient with severe renal insufficiency (eGFR \<30ml/min/1.73m2 based on simplified MDRD equation or CrCl \<30ml/min based on Cockcroft-Gault equation)
* Patient has a malignancy or a life expectancy of less than one year
* Platelet count \<100 000/μL, or hematocrit \<32% or \>52%, or white blood cell count \<3000/μL
* Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor
Echocardiography for RILI Prediction

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation. In this study the investigators want to evaluate the prognostic value of baseline cardiac function assessed with echocardiography for prediction of RILI.

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation (CRT).This side-effect can heavily impact quality of life and is a dose-limiting factor for the treatment. Identifying high risk patients before the start of the treatment would make it possible to adapt the treatment by choosing another radiation technique or proton therapy. However, despite the fact that many patient and treatment characteristics have been associated with RILI, it is not possible to accurately predict the risk of RILI for individual patients. Recently, it has been shown that the radiation dose to the heart is a risk factor for lung toxicity in both animal and clinical studies. Also, in a study, carried out jointly by CARIM and GROW, it was found that patients with a previous diagnosis of cardiac disease had a significantly higher risk to develop RILI after CRT (p-value \<0.001), even with low or no radiation dose to the heart. It is unknown whether asymptomatic cardiac comorbidity is also related to development of RILI. Taking into account that approximately 30% of all lung cancer patients suffer from symptomatic cardiac comorbidity at the start of cancer treatment, there is an urgent need for research projects focusing on cardio-oncology. These projects will make it possible to unravel the complex relationship between heart, lungs, chemotherapy and radiation treatment. In the current project the investigators hypothesize that biomarkers based on echocardiography, which reflects cardiac function, are prognostic for development of radiation induced lung injury after chemoradiotherapy. In addition, the investigators will validate our previous finding that presence of cardiac comorbidity is associated with RILI.

Eligibility Criteria:
Inclusion Criteria:

* Clinical stage I-III non small cell lung cancer, excluding malignant pleural/pericardial effusion
* Planned for curatively intended primary (chemo)radiotherapy, due to irresectable disease and/or medical inoperability
* WHO performance status 0-2
* No history of prior chest radiotherapy
* No uncontrolled infectious disease
* No other active malignancy
* No prior lung surgery (VATS, wedge resection, segment resection, lobectomy)
* Willing and able to comply with the study prescriptions
* 18 years or older
* Ability to give and having given written informed consent before patient registration

Exclusion Criteria:

* malignant pleural/pericardial effusion
* history of prior chest radiotherapy
* uncontrolled infectious disease
* other active malignancy
* prior lung surgery (VATS, wedge resection, segment resection, lobectomy)
A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, ≥ 18 years of age;
* moderate to severe active rheumatoid arthritis (Disease Activity Score (DAS28) \> 4.4);
* inadequate response to methotrexate;
* on a stable dose of ≥ 15mg/week methotrexate for at least 6 weeks.

Exclusion Criteria:

* prior treatment with a biologic;
* Rheumatoid arthritis (RA) functional class IV;
* known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections;
* evidence of active malignant disease.
Evaluate the Shade Matching of Polychromatic Versus Monochromatic Composite Layering Techniques in Fractured Class IV Maxillary Central Incisors Using Universal , Layering & One Shade Composite In-vivo on Patients

The goal of this clinical trial is to evaluate shade matching ability of different techniques of application and different materials of resin composite restorations in class IV carious lesions

Shade matching cabability of different resin composite materials and different techniques for restoration application, layering versus conventional incremental

Eligibility Criteria:
Inclusion Criteria:

1- Fractured class IV upper central incisors.

Exclusion Criteria:

1- cracked teeth
Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy

Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy.

This is a Phase 3, single-arm, open-label, multicenter clinical trial to evaluate both the efficacy and long-term safety of lomitapide in Japanese patients with HoFH receiving maximally-tolerated, stable lipid-lowering therapy. This study is comprised of a run-in period, a primary 26-week Efficacy Phase, and a 30-week Safety Phase.

Eligibility Criteria:
Inclusion Criteria:

1. Japanese male and female patients aged ≥ 18 years of age who are receiving maximally tolerated, stable, lipid-lowering therapy
2. Diagnosis of functional HoFH
3. Body weight ≥ 40 kg and \< 136 kg
4. Negative pregnancy test at screening

Exclusion Criteria:

1. Uncontrolled hypertension
2. History of chronic renal insufficiency
3. History of biopsy proven cirrhosis or abnormal liver function tests (LFTs) at screening
4. Any major surgical procedure occurring \< 3 months prior to the screening visit
5. Cardiac insufficiency
6. Previous organ transplantation
7. History of a non-skin malignancy within the previous 3 years
8. Patients who are not able to limit their alcohol intake
9. Participation in an investigational drug study within 6 weeks prior to the screening visit
10. Known significant gastrointestinal bowel disease
11. Nursing mothers
12. Serious or unstable medical or psychological conditions
13. Requirement for certain prohibited medications known to be potentially hepatotoxic
14. Use of strong or moderate inhibitors of CYP3A4
15. Use of simvastatin at doses \>10 mg per day
16. Documented diagnosis of any liver disease
Suitability of PICC for Transpulmonary Thermodilution Compared to CICC

Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous infusion. In the present study we try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥18 years) admitted to the ICU
* Patients requiring hemodynamic monitoring using EV1000TM
* Patients having both PICC and CICC in place (these patients had their PICC replaced with a CICC, usually at the time of ICU admission, or vice versa, usually at the end of their ICU stay, and were enrolled immediately after the placement of the new device before the previous one was removed)

Exclusion Criteria:

* body weight \<40 kg
* severe aortic regurgitation or intra-cardiac shunt
* treatment with an intra-aortic balloon pump
* contraindication for placement of PICC, CICC or a femoral arterial catheter
* abdominal aneurism
* extracorporeal circulation
* pregnancy
* lack of informed consent
Effects of Local Anesthetic or Saline Solution on Peripheral Nerve Stimulation - a Randomised Study

In this study we want to examine the effect of a small amount of local anesthetic or saline solution on nerve conduction using a peripheral nerve stimulator.

Using electrical nerve stimulation in performing peripheral nerve helps to control the needle position in relation to the nerve and therefore may increase the likelihood of a successful nerve block. Defining the minimal stimulating current accepted also may help to avoid direct contact between nerve and needle or accidental endoneural injection and subsequent nerve lesion.

In recent years there have been many reports where several nerves, parts thereof or plexuses have been anesthetised using a multiple injection approach. That is, nerves in close proximity of each other have been subsequently blocked after using a nerve stimulator to locate them.

It is not clear though, whether a nerve may already be partially anesthetised in this situation and whether that would impair the correct use of a peripheral nerve stimulator.

The aim of this study is to examine the excitability of a peripheral nerve after injecting a small amount of local anesthetic agent or saline solution into the proximity of the nerve.

Eligibility Criteria:
Inclusion Criteria:

ASA 1-2

Exclusion Criteria:

peripheral neuropathy, ASA \>2
The Heidelberg Engineering ANTERION Imaging Agreement Study

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess image quality of acquired biometry images of the eye

The conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. Because the study is not interventional, the study is not an Applicable Clinical Trial per Clinicaltrials.gov definition.

Eligibility Criteria:
Inclusion Criteria:

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. With eye pathology status for each of the two eye populations. A. Eye with normal anterior segment

B. Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to:

* glaucoma surgeries: trabeculectomy, laser peripheral iridotomy and drainage devices
* corneal surgeries: corneal inlays and corneal transplants
* pterygium and corneal scar

Exclusion Criteria:

1. Subjects which were enrolled in the B-2018-1 Study
2. Physical inability to be properly positioned at the study devices or eye exam equipment
3. Contact lenses worn during imaging
Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)

The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase.

Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study.

Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.


Eligibility Criteria:
Inclusion Criteria:

Key Inclusion Criteria Cohort I:

* Documentation of completion of a Novartis AGO178C Double-blind Study in MDD patients.
* Male and female adults, 18 through 71 years of age, inclusive (i.e., same age range as for Double-blind Study, but with upper age limit increased by 1-year to accommodate patients whose age increased during the Double-blind Study).
* Female patients should continue to use effective contraception as defined in double-blind study protocol.

Inclusion Criteria:

Key Inclusion criteria Cohort II:

* Male and female adults, 18 through 70 years of age, inclusive.
* Diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
* Current episode ≥4 weeks.
* CGI-Severity score ≥4 at Screening and Baseline.

Exclusion Criteria:

Key Exclusion Criteria Cohort I:

* Concomitant use of fluvoxamine.
* Any significant medical condition that emerged during Double-blind Phase of a previous study, which may interfere with study participation and/or study assessments as assessed by the investigator.

Exclusion Criteria:

Key Exclusion criteria Cohort II:

* History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
* Any other current Axis I disorder other than MDD which is the focus of treatment.
* Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.
* Prior exposure to agomelatine.
* Female patients of childbearing potential who are not using effective contraception.

Other protocol-defined inclusion/exclusion criteria may apply.
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating adult patients who have stage III or stage IV pancreatic cancer that cannot be removed by surgery.

OBJECTIVES: I. Determine the overall survival in patients with unresectable stage III or IV pancreatic adenocarcinoma treated with gemcitabine, cisplatin, and fluorouracil. II. Determine the resectability rate with curative intent in patients with unresectable stage III pancreatic adenocarcinoma treated with this regimen. III. Assess the tolerability and toxicity of this treatment regimen in this patient population. IV. Evaluate this regimen in terms of response rate, response duration, and overall time to disease progression in these patients. V. Evaluate the quality of life in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, followed by cisplatin IV over 30 minutes on days 1 and 15. Patients receive fluorouracil as a continuous infusion on days 1-15. Courses repeat every 28 days. Quality of life is assessed every 28 days.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed pancreatic adenocarcinoma Unresectable locally advanced (stage III) OR Metastatic (stage IV) Gallbladder or biliary tract cancer allowed No endocrine tumors or lymphoma of the pancreas No CNS metastases

PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than 3.0 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: No active infection No other serious systemic disorders No other active malignancies within the past year except curatively treated basal cell skin cancer or carcinoma in situ of the cervix Must have central venous access device (i.e., Infusaport or PASPORT) Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for locally advanced or metastatic disease At least 6 months since prior adjuvant chemotherapy No prior gemcitabine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Cerliponase Alfa Observational Study in the US

This is a multicenter, observational study for patients with a confirmed diagnosis of neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as TPP1 deficiency, who intend to be or are currently being treated with cerliponase alfa. Patients receiving or expected to receive cerliponase alfa within 60 days of signing the informed consent form (ICF) may be eligible to enroll in the study, assuming all regulatory requirements for sites that have agreed to participate and protocol inclusion criteria are met. Data may be collected for all or some of the assessments as outlined in the protocol, dependent upon the clinic's and/or individual patient's standard of care.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with CLN2 disease.
2. Currently receiving or plan to begin treatment with cerliponase alfa.
3. Written informed consent/assent obtained.

Exclusion Criteria:

1. Currently receiving treatment in another investigational device or drug study.
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adolescents

The purpose of this study is to investigate the effects of dietary exposure to artificial sweeteners on taste sensitivity, preference and brain response in adolescents using fMRI, psychophysical measures, and questionnaires. The investigators hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift preference of sweet and savory taste to a higher dose, and reduce brain response in amygdala to sweet taste compared to sucrose.

We aim to identify neural factors that contribute to taste intensity perception in humans and to determine environmental mechanisms that contribute to variation in taste sensitivity. Significant controversy surrounds the possibility that consumption of artificial sweeteners (AFS) leads to weight gain. Given that the five FDA approved AFSs are found in thousands of foods (Yang 2010) this marks a clear and significant gap in knowledge. Our preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following consumption of a beverage sweetened with two packets of Splenda for just 10 days. These data provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste intensity, most likely by down-regulation of the sweet taste receptor. Adolescents may be more sensitive to exposure to AFS because of changes in metabolism during this period of development. Physiologic insulin resistance occurs during adolescence (Moran, Jacobs et al. 1999); this change in insulin sensitivity may predispose adolescents to greater impairments in sweet taste intensity by altering the relationship between sweet taste and post-ingestive reward, as suggested by the Davidson and Swithers model (Davidson and Swithers 2004). Therefore, it is imperative that we gain a greater understanding of the physiological consequences of AFS use in adolescents, since alterations in sweet taste perception, metabolism and brain reward that occur in response to AFS exposure may promote weight gain.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Fluent in English
* Right handed
* 13-17 years old

Exclusion Criteria:

* History of oral nerve damage, presence of known taste or smell disorder, food allergies or sensitivities (for example nuts, lactose, artificial sweeteners), history of CNS disease, diabetes, history of DSM-IV major psychiatric disorder, including alcohol and substance abuse, chronic use of medication that may affect taste, conditions that may interefere with gustatory or olfactory perception (colds, seasonal allergies, recent smoking history), aberrant stimulus ratings, contra-indication for fMRI, uncomfortable swallowing in supine position, discomfort or anxiety associated with insertion an intravenous catheter, regular artificial sweetener use.
Clinical Value of Remote Ischemic Preconditioning

Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method. Laboratory research has shown promising results regarding myocardial survival during open heart surgery, but the clinical value of RIPC is still largely unknown. The investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of postoperative atrial fibrillation (POAF).


Eligibility Criteria:
Inclusion Criteria:

* Elective isolated on-pump CABG surgery
* Informed consent

Exclusion Criteria:

* Patients with a severe pulmonary disease
* Patients with renal failure (GFR\<30 mL/min/1.73 m2)
* Patients with liver failure
* Peripheral vascular disease affecting the upper limbs
* Patients on sulfonylurea derivatives.
* Patients with atrial fibrillation in their case history
* Prior cardiac surgery (Re-operations)