cyrilzakka/clinical-trials huggingface dataset:
Single Increasing Dose Tolerance Study in Healthy Male Volunteers of BIIR 561 CL

The objective of the study is to obtain information about safety, tolerability and pharmacokinetics of BIIR 561 CL after single intravenous administration of increasing doses in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Age 21 to 50 years
* Broca index from -20% to +20%
* Written informed consent prior to admission to the study

Exclusion Criteria:

* Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values
* Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Known diseases of the central nervous system (CNS) (such as epilepsy), CNS trauma in their medical history or with psychiatric or neurological disorders
* Known history of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
* Intake of any other drug which might influence the results of the trial during the week previous to the start of the study
* Participation in another study with an investigational drug within the last two - months preceding this study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Alcohol use of more than 60 g per day
* Drug dependency
* Excessive physical activities (e.g. competitive sports) within the last week before the study
* Blood donation within the last 4 weeks (\>= 100 ml)
Investigating Lysosomal Storage Diseases in Minority Groups

Although lysosomal storage disorders, such as Fabry disease, Gaucher disease, and Pompe disease, represent serious challenges in the healthcare system, no study has yet investigated the prevalence of these diseases in the US. Frequently, patients show progressive worsening of symptoms for several years before they get diagnosed. Since many of these diseases can be managed therapeutically, it is important to identify and treat patients in order to avoid organ damage. The investigators aim to undertake a screening study that identifies undiagnosed patients with lysosomal storage disorders and determine the prevalence of these diseases with special focus on underrepresented minority groups.


Eligibility Criteria:
Inclusion Criteria:

* Subject is greater than or equal to 1 day of age and less than or equal to 100 years of age
* Subject is managed by a physician in the Washington, D.C metro area
* Subject is getting blood work as part of standard clinical care and there is at least 60 uL blood remained in a tube after all clinical tests were run

Exclusion Criteria:

* Absolute contraindication for blood drawing
* Subject cannot be traced back by the referring physician upon a positive screening result
Hemodynamic Effect of Topical Anesthesia During Induction in Patients Undergoing Cardiac Surgery

Patients scheduled for cardiac surgery are fragile. Hemodynamic fluctuation might be associated with adverse outcomes. Therefore, it is essential to keep hemodynamics stable during and after the induction period. Previous studies have shown that topical anesthesia can provide excellent superior supraglottic and subglottic local anesthetic effects and can significantly reduce the dosage of intravenous anesthetics. Therefore, we designed this study to explore whether the combination of topical anesthesia and intravenous anesthetics could decrease the stress response of endotracheal intubation and keep hemodynamics stable during and after the induction period.

Patients scheduled for cardiac surgery are often accompanied by cardiac insufficiency. Hemodynamic fluctuation might lead to disastrous events. Therefore, it is essential to keep hemodynamics stable during and after the induction period. The routine anesthesia induction strategy for cardiac surgery is to decrease stress response during endotracheal intubation by using large doses of opioids. However, high doses of opioids often leads to persistent and recurrent hypotension in patients from the anesthesia induction period to the beginning of the surgery. Previous studies have shown that topical anesthesia can provide excellent superior supraglottic and subglottic local anesthetic effects and can significantly reduce the dosage of intravenous anesthetics. Therefore, we designed this study to explore whether the combination of topical anesthesia and intravenous anesthetics could decrease the stress response of endotracheal intubation and keep hemodynamics stable during and after the induction period.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years and younger than 75 years;
2. Patients scheduled to accept elective cardiac surgery;
3. Patients of New York Heart Association (NYHA) Ⅱ～Ⅲ level grade ;
4. Patients signed the informed consent form for the clinical study.

Exclusion Criteria:

1. Patients cannot cooperate to topical anesthesia;
2. Patients who had left heart assist devices other than intra-aortic balloon counterpulsation before surgery;
3. Patients treated with Extracorporeal Membrane Oxygenation (ECMO) prior to surgery;
4. Patients with aortic dissection;
5. Patients with difficult airway;
6. Patients with high sensitivity and hypersensitivity to lidocaine;
7. Patients with atrioventricular block;
8. Patients who have participated in other clinical studies during the last 3 months.
Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography

Study purpose: This study will investigate anatomical factors associated with increased risk of major adverse aorta-related event and accelerated growth of abdominal aneurysm based on 3-dimensional analysis of CT images.

Study design: a multicenter single-arm prospective observational study.

Subject: patients with small abdominal aortic aneurysm with maximal diameter of 30-50 mm (n=323)

Methods: Patients diagnosed with small AAA based on CT will be enrolled after considering inclusion and exclusion criteria and prospectively followed clinically and with CT at 1 year.

Primary endpoint: Major adverse aorta-related events (death, aortic rupture, or aneurysm growth \>0.4 cm per year) at 1 year

Secondary endpoints: 1) clinical events : death, aortic rupture, aneurysm growth \>0.4 cm per year, surgical or endovascular repair 2) Changes in CT parameters of aneurysm: diameter, volume, wall shear stress

Prospective single-arm multicenter registry

Eligibility Criteria:
Inclusion Criteria:

- abdominal aortic aneurysm with maximum diameter of 30-50 mm

Exclusion Criteria:

* Age \<19 years
* Serum Cr\> 1.5mg/dL or eGFR\<30 mL/min
* Known allergic reactions to iodine contrast media
* Women in pregnancy or women of childbearing age
* Abdominal aortic aneurysms indicated for endovascular or surgical repair (symptomatic aneurysm or aneurysms with diameter \>5cm)
* Saccular type aneurysm, infected or inflammatory aneurysm
* Combined aortic dissection
* Aneurysms associated with genetic or connective tissue diseases (Marfan syndrome, Shprintzen-Goldberg syndrome, Loeys-Dietz syndrome, Takayasu's arteritis, Behcet's disease)
* Past history of surgical or endovascular repair of aorta
* Any surgical or endovascular repair planned within 1 year
* Life expectancy \< 1 year
EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer

This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor EGFR (EGFR -IL12 -CART) cells in metastatic patients with colorectal cancer.

This is a study for the patients with colorectal cancer. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that EGFR:4-1BB:CD28:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects. Fourth generation CART, also known as TRUCKs (T cells redirected for universal cytokine before), mainly in order to improve the effect of solid tumor treatment and design, through NFAT transcription factors inducing expression of IL - 12, overcome the solid tumor within the tumor microenvironment of CART limit the function of cellsThe purpose of this study is observe the MTD and to assess the safety and feasibility of CART cells in the patients with metastatic colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 18 years to 70 years;
2. Clinical diagnosis of EGFR positive for patients with metastatic colorectal cancer;
3. Patients must have a KPS of \>80, expected survival \> 3 months;
4. Patients must have at least one measurable lesions;
5. Recently did not use glucocorticoid;
6. Patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥100×109/L）; AST ≤2.5ULN，ALT ≤ 2.5ULN; Cr≤ 3ULN; TBIL≤ 3ULN，
7. Patients must have a good heart function (LVEF\>50%) ;
8. Patients must be willing to practice birth control during and for three months following treatment.NOTE:female participants of reproductive potential must have a negative serum pregnancy test, and willing to practice birth control during and for three months following treatment；
9. Patients must be willing to sign an informed consent.

Exclusion Criteria:

1. Patients with other cancer history;
2. Patients allergic to cetuximab;
3. Patients with severe bronchitis, bronchial asthma, or severs pneumonia;
4. Patients with uncontrolled active infections (bacteria, viruses or fungi infection) ;
5. Patients with acute and chronic GVHD (graft versus host disease)
6. Patients with severe autoimmune diseases;
7. Previously treatment with T cell inhibitors (cyclophosphamide, FK506);
8. Patients with active hepatitis B or hepatitis C infection, HIV infection, syphilis serology reaction positive;
9. Patients who are participating or participated any other clinical research in the past 1 months;
10. Pregnant and/or lactating women will be excluded; -
Dynamic Contrast-Enhanced Magnetic Resonance Imaging Analysis for Prognosis of Intracranial Dissecting Aneurysm With Intramural Hematoma After Endovascular Treatment

This study will evaluate the feasibility to predict the prognosis of IDA with IMH by DCE-MRI and provide theoretical basis for the prognosis and intervention of the disease.

Intracranial dissecting aneurysm (IDA) was a challenging disease and could result in stroke in young and middle-aged adults. Intramural hematoma, one of the typical imaging findings of IDA, can grow continuously in untreated IDA. Due to relatively high complication rate associated with surgical procedures, endovascular treatments have become the first-line therapy for such lesions. According to whether the parent artery was maintained, endovascular treatment was divided into deconstructive (proximal arterial occlusion and internal trapping) and reconstructive (stent implantation with or without coiling) techniques . However, recanalization of IDA was a great challenge for endovascular treatment and influenced the prognosis of patients.

The formation of an IMH is a critical event in the progress of IDA and IDA may grow because of recurrent IMH even after deconstructive endovascular treatment. Increased IMH size could result in severe compression symptoms or even death. At present, the mechanism of the continuous growth of intramural hematoma after endovascular treatment of IDA is still unclear. Some authors believe that the continuous hemorrhage of the vasa vasorum in the IMH results in the continuous enlargement of the IMH. However, this theory has not been proved by imaging in vivo.

Dynamic contrast-enhanced magnetic resonance imaging analysis for prognosis of intracranial dissecting aneurysm with intramural hematoma after endovascular treatment (DEMAT) is a prospective trial designed to collect a large series of patients with IDAs treated endovascularly to predict the prognosis of IDA with IMH by DCE-MRI and provide theoretical basis for the prognosis and intervention of the disease.

Eligibility Criteria:
Inclusion Criteria:

adult patients (age 18-80 years) patients' ability to cooperate during the MRI examination; patients who are were diagnosed with IDA according to DSA and MRI; expectation of adequate patient safety during these examinations; unequivocal evidence by MRI (IMH\>5 mm on the perpendicular plane to the long axis of the vessel) of IDA; IDA treated by the endovascular approach; patients' willingness to participate in the study.

Exclusion Criteria:

patients with pre-existing diagnoses of arteritis, fibromuscular dysplasia, iatrogenic aneurysms or pseudoaneurysms; extracranial dissecting aneurysms extended into the intracranial segment; patients with other diseases or poor general condition with expected survival of less than 2 year; the IDA has already been treated by the endovascular treatment; patients lacking DCE-MRI follow up.
Hs-CRP as Clinical Marker of Inflammatory Atherogenic Dyslipidemia

The objective of this proposal is to study the applicability of the hs-CRP assay in the assessment of CV risk in daily clinical conditions where hyperlipidemic population with or without CHD are currently evaluated.

Coronary heart disease (CHD) is the major cause of death in the developed world. Cholesterol screening has been used as a tool to identify individuals who are at increased risk of developing future coronary events, but almost one-half of patients who develop myocardial infarction have either normal or only moderately increased serum cholesterol concentrations. In the last years, experimental and clinical evidence has demonstrated that atherosclerosis is not simply a disease of lipid deposits. Rather, there is growing recognition that CHD has an inflammatory component which plays a critical role in the arterial plaque rupture that triggers most episodes of coronary thrombosis. In the last years, C-reactive protein (CRP), an exquisitely sensitive marker of systemic inflammation, has emerged as a powerful predictor of cardiovascular diseases, in particular of CHD, beyond what can be estimated by traditional risk factors. The availability of high-sensitivity (hs) CRP assays has enabled the detection of even low-grade inflammatory responses that have previously been regarded as clinically not meaningful. However, for hs-CRP to make the transition from epidemiological and clinical research to the routine clinical setting, several important issues must be satisfactorily addressed.

Therefore, the overall objective of this proposal is to study the applicability of the hs-CRP assay in the assessment of CV risk in daily clinical conditions where hyperlipidemic population with or without CHD are currently evaluated and to evaluate hs-CRP response to statins.

Eligibility Criteria:
Inclusion Criteria:

* metabolically stable in the last 3 months for weight (+/- 1 kg), lipid profile (+/- 15 % variability), infection (no symptoms for viral or bacterial illness), inflammation (absence of nonspecific symptoms for arthritis, normal blood sedimentation and protein electrophoresis for acute phase reactants) and no change of usual habits (ex. diet/exercise) or medications (ex. drugs)
* CHD patients will have to be stable (based on cardiac symptoms and ECG) during the last 3 months and diabetic patients will be required to have stable glycemia (HbA1c \< 7,5 %) in the last 6 months.

Exclusion Criteria:

* history of drug or alcohol abuse
* uncontrolled liver, thyroid or kidney functions
* other drugs known to affect lipid levels or insulin resistance (antiprotease inhibitors, oral contraceptives...)
Resistance Training and Blood Flow Restriction

The primary purposes of the proposed study is 1) To examine the changes of muscle fiber cross-sectional areas in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction and 2) To examine changes in motor unit size (a non-invasive measure of muscle fiber size) in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction.

Specific Aims and Hypotheses:

Specific Aim 1: To examine the changes of type I and II (different types of muscle fibers) muscle fiber cross-sectional areas in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction. Hypothesis 1: Type I and II fiber cross-sectional area will increase following low-intensity resistance training with blood flow restriction, however, only cross-sectional area of type II fibers will increase post high-intensity resistance training.

Specific Aim 2: To examine changes in the size of the motor units that are active during low and high intensity contractions in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction. Hypothesis 2: The motor units that are active during low and high intensity contractions will increase in size from low-intensity resistance training with blood flow restriction, but only the motor units that are active during high intensity contractions will increase in size from high-intensity resistance training.

Specific Aim 3: To examine changes in whole muscle cross-sectional area as measured via ultrasound pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction. Hypothesis 3: Whole muscle cross-sectional area will increase to similar degrees from both high-intensity resistance training and low-intensity resistance training with blood flow restriction.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Participants must not have participated in resistance training more than 5 times in the 6 months preceding the study.
* Participants must be healthy and free of any cardiovascular, metabolic or musculoskeletal conditions that may affect the results of the investigation.
* Participants must not have a history of severe hip, knee and/or ankle injuries, or any other pathological conditions that impair their motor control.
* Participants must not have any pre-existing cardiovascular conditions that involve blood flow/blood clotting.
* Participants who are currently taking blood thinners or any medications regulating blood pressures or heart rate will not be eligible to participate in the study.
* Female participants who are pregnant at the start of or who are planning to become pregnant during the resistance training intervention will not be eligible to participate in the study.
Patient Surveys - What Patients Want

This study is to gain insight into patients' preferences considering satisfaction surveys, specifically asking for their most pressing topics and their preferred survey technique.

The practice of patient surveys for quality management is revised at the University Hospital Basel (USB). One aspect is a more versatile data acquisition via online portals and/or paper questionnaires, another aspect is the content of questions and the assessment of demographic data. In this situation a tentative survey on their preferences in this context was realised in patients who were treated in autumn 2016 at the Department of Orthopaedics and Trauma Surgery (DOTS) using a cover letter informing them about the nature of the survey. They were asked to provide few basic demographic data, they were furthermore asked whether they favoured surveys by the USB and if so with which focus. Finally they had the option to name three central topics for feedback and to quantify the number of questionnaires they had so far received by the USB. The survey could be completed in a paper and survey monkey based internet version accessible via a Quick Response (QR) code or link.

Eligibility Criteria:
Inclusion Criteria:

* All data from completed survey sheets (paper questionnaires) and online forms are included

Exclusion Criteria:

* no exclusion criteria
Letermovir (LMV) Prophylaxis in CMV-seronegative Allogeneic Stem Cell Transplant Recipients With CMV Seropositive Donors: an Exploratory Study From Spanish GETH/TC Centers

This is an observational cohort study. Two cohort will be enrolled:

LMV cohort: All patients included in in this study will receive LMV according to standard of care.

Historical cohort: an historical cohort will be included to compare the results of both groups (LMV vs historical cohort).

All patients will receive treatment wtith LMV according to standard of care.

Eligible patients will be enrolled in the study under the supervision of the investigator or designated sub-investigators. If possible, patients will receive treatment on an outpatient basis except for the hospitalization requirement established in the protocol.

Patients will receive oral or intravenous LMV (if available) at a dose of 480 mg/day. For patients receiving concomitant treatment with cyclosporine, the dose of LMV will be 240 mg/day. According to the standard of care, LMV will be administered daily until week 14 post-transplant for up to 8 weeks (\~day 100) starting on day +1.

Patients could be discontinued earlier if, disease progression, patient withdrawal, loss to follow-up, end of study, or death.

After completion of the treatment period, an end-of-treatment visit will occur within 30 days of receipt of the last dose of study drug.

To compare the outcome of the LMV group, a historical cohort will be selected from the national CMV database (GETH-GRUCINI).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* First allogenic HCT
* Pre-HCT patient CMV negative IgG serology with CMV IgG positive donor serostatus
* Able to provide written consent and complete the informed consent
* Absence of CMV DNAemia requiring antiviral therapy within 5 days before initiation of LMV. Low levels CMVDNAemia before the inception of letermovir are allowed

Exclusion Criteria

* Active pre-emptive therapy for csCMV-I.
* Patients who have received LMV prophylaxis prior to enrollment
* Patients enrolled in a CMV pre-emptive therapy clinical trial
* Glomerular filtration rate (GFR) \</=30 mL/min/1.73m\^2 (equivalent to creatinine clearance \</=10 mL/min)
* Severe hepatic function grade 3-4 CTAE at the time of study entry.
* Suspected or known hypersensitivity to active or inactive ingredients of LMV formulations
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to letermovir.
* Pregnancy or breastfeeding
* Plans to conceive or father children within the projected duration of the trial
* History of current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or would place the subject at undue risk as judged by the investigator, such that it is not in the best interest of the subject to participate in this study