cyrilzakka/clinical-trials huggingface dataset:
Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer.

OBJECTIVES:

* Determine the toxicity, maximum tolerated dose, and pharmacokinetics of monoclonal antibody hu3S193 in patients with advanced colorectal carcinoma.
* Determine the immune response in these patients treated with this regimen.

OUTLINE: This is a dose escalation study.

Patients receive monoclonal antibody hu3S193 (mAb hu3S193) IV over 30 minutes to 4 hours weekly for 8 weeks followed by 2 weeks of rest. Patients with stable or responding disease at week 10 receive maintenance mAb hu3S193 weekly. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of mAb hu3S193 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven stage IV colorectal carcinoma.
* Failed or refused conventional chemotherapy.
* Lewis Y antigen present on more than 50% of tumor cells.
* Measurable or evaluable disease.
* No central nervous system (CNS) tumor involvement.
* Karnofsky 80-100%.
* Life expectancy: At least 6 weeks.
* Granulocyte count greater than 1,500/mm\^3.
* Platelet count greater than 100,000/mm\^3.
* Bilirubin no greater than 1.0 mg/dL.
* Prothrombin time less than 3 times upper limit of normal.
* Creatinine no greater than 1.4 mg/dL.
* Female patients of childbearing age and male patients must be asked to use effective contraception during the study.
* At least 4 weeks since other prior immunotherapy. Exclusion Criteria
* New York Heart Association class III or IV heart disease.
* Serious infection requiring antibiotics or other serious illness.
* Pregnancy or nursing.
* History of bleeding gastric ulcers or pancreatitis.
* Diabetes mellitus requiring insulin.
* Human antimouse antibodies (HAMA).
* No prior mouse monoclonal antibody or antibody fragments.
* Illness requiring the use of steroids or other anti-inflammatory agents.
* Positive anti-hu3S193 antibody (HAHA) titer.
Non-invasive Diagnosis of Pulmonary Hypertension by Impedance Cardiography

The goal of the study is to prospectively evaluate Impedance Cardiography as a tool to detect pulmonary hypertension. According to our hypothesis Impedance Cardiography is a valuable method to differentiate patients without pulmonary hypertension from patients with pulmonary hypertension. The main objective is to determine the sensitivity and specificity in comparison to the gold standard right heart catheterization.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* Patients with clinical indication for right heart catheterization

Exclusion Criteria:

* known Pregnancy
Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer

A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (\>= Grade 3) select treatment-emergent adverse events (TEAEs).


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Minimum life expectancy of at least 12 weeks.
* Laboratory values meeting the criteria specified in the protocol.
* Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen.
* Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue.
* Measurable disease as described per protocol.
* In participants with a history of central nervous system (CNS) metastases, documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids.

Exclusion Criteria:

* Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III - IV within 6 months prior to first dose of study drug.
* Recent or on-going serious infection.
* History of other invasive malignancy that has not been in remission for at least 3 years.
* History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation.
* Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
* Documented history of capillary leak syndrome.
* Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing requirements for pericardiocentesis or thoracentesis.
A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer

Comparing the effect of switching from Lupron and Zoladex to Eligard. PSA and Testosterone levels are measured at set intervals to determine if Eligard is equal or better then Lupron or Zoladex in advanced Prostate Cancer patients.


Eligibility Criteria:
Inclusion Criteria: Patient with Advanced Ca, on stable dose of Lupron or Zoladex

-

Exclusion Criteria:

* Previous exposure to Eligard.
Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance

The current international guidelines for CRC surveillance in IBD recommend as first choice the use of chromoendoscopy, and as an alternative high-definition white light endoscopy (HDWLE) for optimal dysplasia detection, based on data from clinical trials. However, data on the superiority of CE over HDWLE are not consistent in literature. The investigators hypothesize that the better performance of CE in some clinical trials is the result of the associated longer procedural time and the fact that every colon segment is examined twice. Currently, no studies have been published evaluating the dysplastic yield of back-to back HDWLE compared to HDWLE with a single pass or CE in patients with IBD. In the present study, the investigators aim to compare the yield of dysplasia/CRC between 1) regular HDWLE, 2) HDWLE back-to-back, and 3) CE.

The investigators assume based on previous research a yield of 12% using high-definition white light endoscopy and 24% using either chromoendoscopy or high-definition white light endoscopy with a second examination (Imperatore et al 2019). To show non-inferiority of back-to-back HDWLE compared to CE, with a non-inferiority margin of 10% (power 80% and alpha 5%,) a total of 226 patients per group is required.

To demonstrate a superiority of back-to-back HDWLE compared to a regular HDWLE, with a 1:2 allocation ratio of single-pass vs back-to-back , 113 and 226 patients per group are needed to achieve 80% power with an alpha of 5%. Therefore, the investigators will include 226 patients in group back-to-back HDWLE, 226 in group CE, and 113 patients in group regular HDWLE. This amounts to a total of 560 patients. To account for any screen-failures The investigators will include at most 5% (of 560) additional patients until 80% power is reached.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patients with inflammatory bowel disease, an estimated involvement of at least 30% of the colonic surface and a disease duration of at least 8 years (or any disease duration in case of concomitant primary sclerosing cholangitis).
* Previous assessable surveillance endoscopy \> 1 year
* Age \> 18 years

Exclusion Criteria:

* Active colitis \> 20 cm and/or inflammation resulting in an insufficient surveillance procedure according to the endoscopist.
* Allergy or intolerance to methylene blue
* Insufficient bowel cleansing (BBPS \<6)
* Refusing or incapable to agree with informed consent
* Pregnant women
* \> 50 % of the colon surgically removed
Hospital-acquired Pneumonia in Intensive Care Unit

hospital-acquired pneumonia are a common disease in intensive care unit. The prevention, the diagnosis and the treatment of hospital acquired pneumonia are a frequent challenge. Nevertheless it seems that there are great differences in standard of care between hospitals. The investigators hypothesized that medical education and implementation of evidence-base guidelines can reduce the duration of mechanical ventilation in patients presenting of hospital acquired pneumonia

The before period (phase 1) will consist of all consecutive patients admitted to the participating ICUs before the national guidelines publication concerning healthcare associated pneumonia.

The second period (phase 2) will consist of all consecutive patients admitted to the participating ICUs after the publication of the national guidelines publication concerning healthcare associated pneumonia.

Afterward, an interphase will occur during which all physicians, residents, physiotherapists and nurses will receive a formal training for the processes and procedures related to the new guidelines published in september 2017.

In the intervention group, on top of the standard training, the centers receive an analysis of the evolution of the practices of their center and the future of their patients between phases 1 and 2, as well as these same values for the data set. The centers are then called to conduct a meeting to determine their priority improvement points based on this audit.

The third and final period (phase 3) will consist of all consecutive patients admitted to the participating ICUs after the formal training.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years ; IGS-II score \> 15 ; Hospital stay \>= 3 days

Exclusion Criteria:

* Community-acquired pneumonia, pregnant women, refusal to participate
Individual Patient Expanded Access for AB-PA01, an Investigational Anti-Pseudomonas Aeruginosa Bacteriophage Therapeutic

The purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, AB-PA01, for patients with serious or immediately life-threatening Pseudomonas aeruginosa infections, for which no alternative treatment(s) are currently available, and who meet the criteria for treatment under FDA's Expanded Access regulations and criteria set forth by AmpliPhi Biosciences Corporation.

To be considered for expanded access, the request should be submitted to AmpliPhi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. Treating physicians should contact AmpliPhi by emailing expandedaccess@ampliphibio.com with "Expanded Access Request" in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition.

Any approval of expanded access to investigational medicine must always comply with the applicable laws and regulations.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Safety and Efficacy of Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops in the Treatment of Seasonal Allergic Rhinitis (SAR) in Children and Adolescents

Ectoin acts on membranes by forming an Ectoin-Hydro-Complex therewith providing a protection against external agents like aeroallergens. The effects of Ectoin containing nasal spray and eye drops have already been demonstrated in several studies with adult Seasonal Allergic Rhinitis (SAR) patients and it was shown that they can effectively reduce symptoms of allergic rhinitis without resulting in any significant adverse events.

The aim of this clinical investigation is to demonstrate the safety, tolerability and efficacy of Ectoin Nasal Spray and Ectoin Eye Drops in pediatric and adolescent SAR patients. It is assumed that Ectoin containing products show an excellent safety profile and very good tolerability together with a potent efficacy in the treatment of SAR.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-17 years
* diagnosed seasonal allergic rhinitis
* general good health condition other than SAR, and free of any concomitant conditions or treatment that could interfere with clinical investigation conduct, influence the interpretation of clinical investigation observations/results, or put the patient at increased risk during the clinical investigation
* Sum of Total Nasal Score (TNSS) ≥ 6
* Sum of Total Ocular Score (TOSS) ≥ 4

Exclusion Criteria:

* - Confirmed diagnosis of acute or chronic rhinosinusitis, as determined by the investigator
* History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the screening visit)
* Chronic or intermittent use of intranasal, oral, intramuscular, intravenous or ophthalmic corticosteroids
* Ocular disorder other than allergic conjunctivitis, except hyperopia and myopia and strabismus
* Upper and lower airway respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)\] within 4 weeks prior to clinical investigation start or development of a respiratory infection during the run-in period
* Start of specific immunotherapy within 1 month preceding enrolment in the clinical investigation or change in dose of immunotherapy throughout the trial
* Chronic moderate to severe asthma according to GINA criteria which is treated with inhaled corticosteroids (ICS) and additional anti-asthmatic treatment. Patients with mild co-seasonal asthma must not change their dose regimen of ICS within 4 weeks prior to the enrolment into the clinical investigation nor during the clinical investigation
* Other respiratory diseases (e.g. Chronic obstructive pulmonary disease (COPD), cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, bronchiectasis, allergic alveolitis, tuberculosis, emphysema, etc.)
* on investigators discretion
Comparison of 2 Vials of Components of a Synthetic Geranium Oil

The purpose of this study is to determine which component of an artificial geranium oil helps to reduce your neuropathy pain.

EPT 101 is a double-blind successive crossover study designed to determine which components of a synthetic geranium oil provide analgesic relief, with the objective of identifying and purifying the active substance. This is not a hypothesis-generating trial, nor is it confirming a hypothesis. The trial uses human volunteers in an efficacy-directed decomposition of a complex mixture.

Patients with a diagnosis of neuralgia or neuropathy who respond to geranium oil will test two vials of components of a synthetic geranium oil for application to the maximally painful area in succession. They will treat their condition in the clinic and fill out a patient diary on separate days. The primary objective is the patient opinion of which vial has greatest analgesic efficacy. Efficacy will be measured primarily by reduction in pain intensity summed over the first two hours, compared with the pain intensity during the 30 minutes preceding application.

Following the comparison of the first two vials, the vial judged efficacious will be decomposed into two further vials and the patients will repeat the evaluation described above. At least eight pair-wise comparisons will be required to determine and confirm which of the 100+ ingredients of a synthetic geranium oil are analgesic, provided there is only one such ingredient.

Eligibility Criteria:
Inclusion Criteria:

* You are eligible to participate in this study if you have completed the study EPT 100 and geranium oil relieves your neuropathy pain successfully.

Exclusion Criteria:

* You are ineligible to participate in this study if you have completed the study EPT 100 and geranium oil does not relieve your neuropathy pain successfully
A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy

The purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.

Adult patients with hypertrophic cardiomyopathy and without known atrial fibrillation or pacemaker/implantable cardiac defibrillation will undergo implantable loop recorder implantation. No direct interventions will be performed. Prospective observation of atrial and ventricular arrhythmia incidence and burden will be assessed, with additional analyses performed based on the presence or absence of obstructive sleep apnea.

Eligibility Criteria:
Inclusion Criteria:

* Currently or previously enrolled in 17-003514 and 16-009474
* Adults age \>18 years-old with a diagnosis of hypertrophic cardiomyopathy
* Both sexes
* Able to consent

Exclusion Criteria:

* Vulnerable study population
* Known atrial fibrillation or flutter (with the exception of post-operative atrial fibrillation)
* Pacemaker/ICD implantation
* Pregnancy
Soothe Versus Refresh

To determine the ocular efficacy and safety of Soothe and Refresh Tears.


Eligibility Criteria:
Inclusion Criteria:

* adults with a diagnosis of dry eyes
* Schirmer's with anesthesia grade between 1-7 mm inclusive after five (5) minutes in at least one eye
* a corneal staining grade of greater than or equal to 2 (scale 0-4) in the same qualifying eye as the Schirmer's test

Exclusion Criteria:

* contact lens use during the active treatment periods of the trial
* history of Sjogren's Syndrome
* temporary punctal occlusion that is still effective
* the current or anticipated use during the study of punctual plugs
* current treatment with Restasis
Working Memory Quality of Attentional Templates

In this line of research, the researchers are examining a basic science question regarding the working memory representations underlying visual search using a positive template (looking for a target) or a negative template (avoiding a distractor).

When finding a search target, receiving a target cue or distractor cue can increase search efficiency. Critically, in order to use these cues to help search performance, they must be maintained in working memory. The researchers are examining whether the working memory representations are of similar quality for a target cue (positive template) or distractor cue (negative template).

Eligibility Criteria:
Inclusion Criteria:

* normal or corrected to normal visual acuity, normal color vision

Exclusion Criteria:

-
Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease

Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients, and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18 years old who were diagnosed as CAD and received antiplatelet therapy were prospectively enrolled in this national wide, non-intervention registry. All medications and laboratory tests were physician discretion.

Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients, and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18 years who were diagnosed as CAD and received antiplatelet therapy were prospectively enrolled in this national wide, non-intervention registry. All medications and laboratory tests were at physician discretion.

Eligibility Criteria:
Inclusion criteria:

1. Clinical diagnosis of coronary heart disease
2. Age \>= 18 years old
3. receiving any antiplatelet agents
4. Informed written consent signed

Exclusion Criteria:

1. With severe disease and life expectancy for 6 months or less
2. Difficult to attain follow-up situations judged by researchers (travel, speech or mental disorder, etc.)
3. Taking part in an interventional clinical research
Atorvastatin in Relapsing-Remitting Multiple Sclerosis

A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. Patients are screened and enrolled in the outpatient clinic of the Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in clinical scores and immune responses.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 55 years old
* MS diagnosis according McDonald criteria
* Relapsing-remitting MS
* EDSS 0 - 6
* Disease activity as occurrence of CEL in brain MRI
* IFN-beta therapy for at least 6 months

Exclusion Criteria:

* Primary chronic progressive MS
* Symptoms and signs of clinical disease conditions similar to MS
* Conditions that can disturb MRI measurements
* Clinically relevant GI diseases eg Colitis ulcerosa, Crohns disease, history of Ulcus pepticum
* Clinically relevant lung, heart, CNS, infectious disease
* Clinically relevant liver, kidney or bone marrow abnormalities (as defined by specific clinical chemistry values)
* Allergies towards Gd-DTPA
* Allergies towards constituents of the therapeutic agent
* Recruitment to other clinical trials within 6 months prior to or during this study
* Pretreatment with complete lymph irradiation, antibody therapy against lymphocyte populations (eg. anti-CD4, Campath-1H), mitoxantrone, cyclophosphamide, cyclosporin A, human antibodies, all immunomodulatory or immunosuppressive agents including recombinant cytokines or other potential experimental MS therapies (6 months prior to study start), glatiramer acetate, azathioprine, IVIg (6 months prior to study start) pregnancy or lactation
* Alcohol or drug abuse
* Inhibitors of Cytochrom P 450 3A (eg. cyclosporin, macrolide antibiotics, azole antimycotics).
* Medical or psychological conditions that could hamper with the patients capacity to understand patient information, to give the informed consent, to adhere to the protocol of the study and to be able to complete the study