cyrilzakka/clinical-trials huggingface dataset:
Two Rebeccamycin Analogue Regimens in Treating Patients With Advanced or Recurrent Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of rebeccamycin analogue is more effective in treating non-small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two rebeccamycin analogue regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

OBJECTIVES:

* Compare the efficacy, in terms of response rate, in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue via 1 infusion vs 5 daily infusions every 3 weeks.
* Compare the response duration in patients treated with these regimens.
* Compare the toxicity profiles of these two regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 or 1 vs 2) and participating center. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1.
* Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36-64 patients (18-32 per arm) will be accrued for this study at a rate of 3-4 patients per month.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven stage IIIB (with pleural effusions), IV, or recurrent non-small cell lung cancer with failure on 1 prior chemotherapy regimen
* Measurable disease

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* WBC at least 3,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 10 g/dL

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* AST and ALT less than 2 times normal

Renal:

* Creatinine normal OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No New York Heart Association class III or IV heart disease

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* No more than 1 prior chemotherapy regimen
* At least 4 weeks since prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No concurrent combination antiretroviral therapy for HIV
EpiFaith Syringe for Epidural Space Detection

The objective of the study is to verify the efficacies of both air and saline based procedure of EpiFaith syringe for assisting the needle localization of the epidural space.

This is a single blind, randomized study. Subjects who will receive a surgery requiring epidural anesthesia or analgesia and meet all of the study criteria will be enrolled in the study. All subjects must sign an informed consent and receive a copy of the signed and dated informed consent form prior to participation in the trial.

The study consists of 2 study visits: Visit 1 (Screening Visit) and Visit 2 (Operative Visit). After screening, eligible subject will be randomly assigned to one of the following groups: Group A: detection by EpiFaith syringe with air; Group S: detection by EpiFaith syringe with saline with a 1:1 ratio. In Visit 2, the following variables will be recorded and rated during the process of epidural space localization: Success of epidural localization, time to identify the epidural space, duration of the epidural space localization procedure, number of attempts, Number of the occurrence of false positive, the distance from the skin to the epidural space, and number of change insertion segment. Adverse events and concomitant treatments will be also recorded.

Eligibility Criteria:
Inclusion Criteria:

* 20 years and older
* Surgery requiring epidural anesthesia or analgesia
* ASA Physical Status 1 to 3

Exclusion Criteria:

* Bleeding and clotting disorders

  * Platelet count \< 100,000 / mm3
  * International normalized ratio (INR) \> 1.5
* History of peripheral neuropathy
* Neuromuscular or neuropsychiatric disease
* Marked spinal deformities or a history of spinal instrumentation
* Systemic infection
* Skin infection at the injection site
* Significant heart failure, e.g. New York Heart Association (NYHA) Functional Classification 3 or 4
Betaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy

Chronic viral cardiomyopathy is a disease where the cardiac muscle is attacked by a virus and this may result in a reduction in the output of the heart (pump function) thereby causing complaints such as chest pain, shortness of breath and palpitations.

Betaferon (interferon beta-1b) is marketed for the treatment of Multiple Sclerosis already, but until now, it has not been proven whether it is also effective in patients with chronic viral myocardial disease.

This study will be conducted to examine the efficacy and safety of Betaferon in patients with this disease. The aim of the treatment is to eliminate the virus from the heart so that the heart function and clinical status can gradually improve.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Unexplained heart with evidence of Adeno-, Entero- and/or Parvoviruses which must be identified directly in the heart tissue
* Being in a chronic (at least 6 month after the onset of clinical symptoms) and stable phase of the disease
* Impaired cardiac function

Exclusion Criteria:

* Severe (decompensated) or acute heart failure.
* Any other disease which could better explain the patient's clinical symptoms
* Any other severe and/or malignant disease.
* Suffering from convulsions, depression or suicidal ideas judged by a physician
* Serious viral or bacterial infections during the last weeks
* Pregnancy or lactation
Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients who have surgically resected, newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma.

OBJECTIVES:

* Determine the toxicity of adjuvant dose-intensive induction chemotherapy with cisplatin, vincristine, cyclophosphamide, and etoposide with or without methotrexate followed by standard radiotherapy in patients with surgically resected, newly diagnosed high stage medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma.
* Determine the response rate, time to progression, overall survival, and pattern of failure in these patients treated with this regimen.

OUTLINE: Patients receive dose-intensive induction chemotherapy consisting of cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; and etoposide and cyclophosphamide IV over 1 hour on days 1 and 2. Patients with M1+ disease (i.e., evidence of dissemination beyond primary tumor site) also receive methotrexate IV over 4 hours on day 3. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover. Chemotherapy continues every 21-28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo radiotherapy 5 days a week for 6.5 weeks beginning 3-6 weeks after completion of chemotherapy.

Patients are followed at 6 weeks, then every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histological confirmation of one of the following:

  * High stage medulloblastoma with neuraxis dissemination (Chang stage M1 or greater)
  * Primitive neuroectodermal tumor
  * Ependymoma

    * Incompletely resected on postoperative MRI or neurosurgical report
* Definitive prior surgery within 42 days of study

PATIENT CHARACTERISTICS:

Age:

* 10 to 65

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin less than 1.5 mg/dL
* SGPT less than 2.5 times upper limit of normal

Renal:

* Creatinine clearance greater than 60 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Prior corticosteroids allowed
* No concurrent corticosteroids as antiemetics

Radiotherapy:

* No prior radiotherapy

Surgery:

* See Disease Characteristics
Unfractionated Heparin in COVID-19 and Non-COVID-19 Patients

The majority of ICU patients with COVID-19 show profound activation of coagulation, potentially resulting in thromboembolic events. In the treatment of these thromboembolic events it seemed that very high dosages of unfractionated heparin were necessary to achieve therapeutic values of aPTT and anti-Xa levels. The aim of this study is to explore whether heparin dosages are higher in COVID-19 patients compared to non-COVID-19 patients, to determine the correlation between aPTT and anti-Xa values and to explore possible causes for non-correlating aPTT and anti-Xa, including CRP and AT plasma levels.

CoVID-19 is a viral disease caused by SARS-CoV-2 virus that may affect many organ systems. Patients with severe disease almost invariably have profound pulmonary inflammation and may require mechanical ventilation and prolonged ICU admission. Mortality in ICU patients may be up to 50%. In the majority of patients with CoVID-19 in the ICU, profound activation of coagulation is present as reflected by d-dimer levels up to 20.000 mg/L or higher. Patients with proven pulmonary thrombosis are commonly treated with unfractionated heparin (UFH). Typically, it seemed that very high dosages of UFH were necessary to achieve therapeutic values of aPTT and anti-Xa levels in COVID-19 patients. Though, the question remains whether dosages given in COVID-19 patients were indeed extravagant compared to non-COVID-19 patients and what potential causes of these high dosages might be. Earlier research already implied that APTT, which is a primarily used parameter to dose UFH, is not accurate and rather anti-Xa levels should be used. Other potential reasons for the high doses are that COVID-19 patients show signs of heparin resistance, possible due to high inflammation parameters. As overdosing of heparin can lead to serious bleeding complications, more understanding on heparin dosage, e.g. parameters to rely on and potential influencing factors, in COVID-19 patients is needed. The primary objective of this study is to determine whether heparin dosages are higher in COVID-19 patients compared to non COVID-19 patients. The secondary objective is to determine the correlation between aPTT and anti-Xa values and to explore possible causes for non-correlating aPTT and anti-Xa, including CRP and AT plasma levels.

Eligibility Criteria:
Inclusion Criteria Covid-19 group:

* Covid-19 disease proven by PCR of nose- or airway sample
* Age ≥ 18 years
* Admitted to the ICU from the 15th of March 2020 until 1st of January 2022
* Treated with unfractionated heparin aiming at aPTT 60-80 sec and/or anti-Xa level 0.3-0.7 iE/ml

Inclusion Criteria non-Covid-19 group:

* Age ≥ 18 years
* Admitted to the ICU between the 1st of January 2014 and 1st of January 2020
* Treated with unfractionated heparin aiming at aPTT 60-80 sec and/or anti-Xa level 0.3-0.7 iE/ml

Exclusion Criteria:

- Treatment with anticoagulants other than UFH or fibrinolytics
Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine

To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an apparatus to examine head-neck-coordination was constructed.

Two different surgical techniques will be compared:

Laminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open approach vs MIS-approach. Each patient will be tested before surgery, postoperative as well as 3 and 12 month follow-up.

Hypothesis is that patients after MIS-approaches perform better in their head-neck-coordination as patients with open approaches.


Eligibility Criteria:
Inclusion Criteria:

* radicular or myelopathic compression syndrome in the cervical spine

Exclusion Criteria:

* neurological diseases with influence on the neuromuscular function
* previous surgery on the cervical spine
Observational Study on Respiratory Impact of High-frequency Jet Ventilation (JVHF) in Interventional Radiology (RI)

Jet ventilation is used in interventional radiology to reduce respiratory movement and facilitate tumor destruction. The purpose of this study is to describe the respiratory impact of this technique

Use imaging and respiratory data to describe the impact of JVHF during tumor thermoablation procedures

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient benefiting from an abdominal tumor thermoablation procedures
* Patient who gave consent
* Patient with a social protection scheme

Exclusion Criteria:

* Pulmonary thermoablation procedures
* Thermoablation of abdominal tumors required a transpleural passage
* Patient under guardianship or curatorship
* Patient not understanding French
Biomarker of Acute Exacerbation of COPD

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the main factor that leads to the deterioration of the disease. Currently, the diagnosis of AECOPD mainly relies on clinical manifestations, and good predictors or biomarkers are lacking. This study aims to explain the gene expression changes related to the disease at the transcriptional level and validate it in multiple levels, reveal specific biomarkers and potential pathogenesis, to provide a research basis for the diagnosis and treatment of AECOPD.


Eligibility Criteria:
For stable COPD:

Inclusion Criteria:

1. Over 40 years old.
2. in line with the diagnostic criteria in GOLD 2018.
3. with the ability to sign informed consent.
4. can be followed up according to the study protocol.

Exclusion Criteria:

1. with other pulmonary diseases (such as lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis, cystic fibrosis) and severe α1-antitrypsin deficiency.
2. with other inflammatory diseases (such as rheumatoid arthritis and inflammatory bowel disease, etc.).
3. a history of pulmonary surgery, or a diagnosis of malignant tumor recently.
4. a history of blood transfusion in 4 weeks.
5. participating in a double-blind drug clinical trial.
6. unable to walk.
7. using oral or intravenous steroid therapy.
8. with acute exacerbation in 4 weeks.

For AECOPD:

Inclusion Criteria:

Patients who were over 40 years old were eligible for inclusion if they had a diagnosis of COPD in their primary care clinical record and were presenting with an acute exacerbation of respiratory symptoms.

Exclusion Criteria:

1. Other specific diseases that may account for sudden changes in respiratory symptoms should be excluded by clinical or laboratory tests.
2. The remaining exclusion criteria were consistent with the above five criteria in stable COPD.

The control group:

Inclusion Criteria:

Healthy people over 40 years old.

Exclusion Criteria:

with chronic airway diseases and other lung diseases, and heart, kidney, liver, and other important organ diseases.
Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)

Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy (28 days).


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years and older
* Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard criteria
* Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy
* Primary resistance to fludarabine-based therapy (no complete response \[CR\] or partial response \[PR\]) or progressive disease within 6 months of response to prior fludarabine containing regimen.
* ECOG performance status of 0, 1, 2 or 3
* Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after
* All investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug.

Exclusion Criteria:

* Pregnant or nursing
* Unable or unwilling to sign consent
* Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy
* Active serious infections that are not controlled by antibiotics
* ECOG performance status 4
* Inadequate renal function: creatinine 2.0 or more unless related to the disease
* Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease
* Known positive test for HIV
* Patients with known hepatitis B and/or hepatitis C active infection
Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique

The main objective is to assess whether a novel electrochemical tool is reliable in detecting concentration of paracetamol in fingerprick- , saline-, urine-, and serum samples. We will recruit 12 healthy volunteers aged 18-45. They will get 1 g oral paracetamol. Paracetamol concentration will be detected from abovementioned samples at timely intervals for 24 hours, analyzed with the novel electrochemical method and compared to gold standard mass-spectrometry analysis.

Despite of extensive use, the mechanism of action of parasetamol is not completely understood. The central serotonergic system may play a role. Endocannabinoid system is a group of lipid mediators, that possibly is involved in mediating paracetamol effect to the serotonergic system. Serum lipidomic assessment can be used to study endocannabinoid metabolics. In this study we will try to assess changes in endocannabinoid system by looking into serum lipidomics in order to understand the mechanism of action of paracetamol.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, no medication of any kind.
* Age 18-45
* BMI 18.5 - 30
* Informed consent

Exclusion Criteria:

* Pregnancy, lactation.
* prisoner
* smoking
* less than 3 months from prior blood donation or clinical pharmacological study
Needle Nerve Contact in Ultrasound Guided Femoral Block

Ultrasound-guided femoral nerve block is a common regional anesthesia technique. The optimal method of needle guidance (in-plane versus out-of-plane) with regards to the block efficacy and avoidance of needle-nerve contact has not been established. In this study the investigators tests the hypothesis that the incidence of needle-nerve contact is higher with the needle insertion in an out-of-plane than with the in-plane approach.

Fourty-four patients with hip fracture (American Society of Anesthesiologists physical status 1-3) are being randomized to receive the femoral block with an out-of-plane (needle inserted at a 45°-60° angle 1 cm caudal to the midpoint of the ultrasound probe just above the femoral nerve) or an in-plane technique (needle inserted 0.5 cm from the side of the probe lateral to the femoral nerve). The data collected includes the depth of needle insertion at the endpoint before injection, response to nerve stimulation, distribution of the injected volume in relation to the nerve (anterior vs posterior, the latter indicating impalement), block efficacy at 20 minutes and 24 hours, and any signs of nerve injury).

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-3 patients
* Diagnosis of trochanteric or cervical hip fracture
* Hip replacement under spinal anesthesia

Exclusion Criteria:

* Patients under the age of 65 years or over the age of 90 years
Identification of Palliative Care Needs and Prognostic Factors of Survival in Tailoring Appropriate Interventions in Advanced Oncological, Renal and Pulmonary Diseases

This is a prospective observational study done on 3 patient populations (cancer, chronic pulmonary and renal disease). All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.

This is a prospective observational study done on 3 patient populations (cancer, chronic pulmonary and renal disease). All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. The primary objective is to analyze appropriateness and timeliness of progressive palliative care approach (initially simultaneously with ongoing disease-oriented treatment and subsequently possibly as the only modality of care to avoid aggressiveness of care) in patients with:

* First diagnosis of advanced metastatic non-small cell lung cancer, or advanced gastric cancer or advanced pancreatic adenocarcinoma
* advanced chronic respiratory failure, caused by chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF).
* advanced chronic renal failure

Eligibility Criteria:
Inclusion Criteria:

* Both sex;
* All ethnic background;
* Age ≥18 years;
* Subjects who are, in the opinion of the Investigator, able to understand this study and to cooperate with the study procedures;
* Written informed consent;
* Not receiving care from the palliative care service

Inclusion Criteria specific for POPULATION A:

* Diagnosis of inoperable locally advanced and/or metastatic non-small cell lung cancer, or gastric cancer or pancreatic adenocarcinoma within the previous eight weeks, any T, any N, M+ or T4 inoperable (neoadjuvant excluded);
* Life expectancy \>2 months;

Inclusion Criteria specific for POPULATION B:

* Diagnosis of chronic obstructive pulmonary disease (COPD) with at least two of these characteristics: age \> 70 years, FEV1 \<30 % predicted, oxygen-therapy dependency, \> 1 admission/year in hospital for COPD exacerbated, congestive heart failure and/or other comorbidity, weight loss/cachexia, reduced functional autonomy, increase dependence.
* or idiopathic pulmonary fibrosis (IPF) diagnosis with at least two of these characteristics: age \> 70 years, histological pattern "UIP" (if known), dependence on oxygen-therapy, radiological aspect of "Honeycomb" to the HRTC of the thorax, reduced functional autonomy, increased dependence.

Inclusion Criteria specific for POPULATION C:

- Diagnosis advanced chronic renal failure with at least two of these characteristics: age \> 75 years, advanced malignancy, severe malnutrition, cardiac or pulmonary pathology terminal, Multiple Organ Failure in Intensive Care.