cyrilzakka/clinical-trials huggingface dataset:
Tetracycline to Limit the Innate Immune Response in Acute Respiratory Distress Syndrome

The acute respiratory distress syndrome (ARDS) is a severe form of respiratory failure with a mortality rate of approximately 40%. Despite advances in its supportive treatment such as lung protective ventilation or restrictive fluid management, no effective pharmacotherapy exists to treat ARDS. Emerging preclinical data indicates that excessive activation of the inflammasome-Caspase 1 pathway plays a key role in the development of ARDS. Tetracycline has anti-inflammatory properties via inhibiting inflammasome-caspase-1 activation. Since not much is known about the activation of the inflammasome in clinical ARDS, the purpose of this study is i) to investigate the the inflammasome-caspase-1 activation in clinical ARDS and ii) inhibit the innate immune response of alveolar leucocytes obtained by tetracycline from patients with ARDS


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Informed consent of the patient
* Diagnosis of ARDS for \< 48 h

Exclusion Criteria:

* Age \< 18 years
* Missing informed consent
* Immune therapy
* Autoimmune disease
Profonycia - Honey for Improving Quality of Patient's Life Receiving Chemotherapy

Myelosuppression (bone marrow suppression) is the most important toxic side effect of the majority of chemotherapeutic agents and typically is the dose limiting factor. Death occurring after chemotherapy usually results either from infection related to drug induced leucopenia or from bleeding related to thrombocytopenia. Colony stimulating factors (CSFs) are widely used in the treatment of chemotherapy induced neutropenia. The same Erythropoetines are used in the treatment of chemotherapy induced anemia. Both treatments are expensive and have several side effects.

In our previous stud (1) we found a special kind of honey: Life-Mel Honey to reduce the incidence of chemotherapy induced pancytopenia and improving quality of life.

The aim of the recent planed study is to provide prophylactic and protective treatment against neutropenia reducing the need for secondary CSF administration in patients receiving chemotherapy along with a natural and non expensive honey: Profonycia.

This honey which is expressed in Kibutz Shamir in Upper Galliee seems promising and easy for administration: given 5 gr/day per os for 7 days from the administration of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

Patients 18 years old or elder receiving chemotherapy 1/2-3 weeks

Exclusion Criteria:

Patients below 18 years old
Gene Expression in Predicting Response to Paclitaxel in Patients With Breast Cancer

RATIONALE: DNA analysis of tumor tissue may help doctors predict how patients who receive paclitaxel will respond to treatment.

PURPOSE: This laboratory study is evaluating gene expression in predicting response to paclitaxel in patients with breast cancer.

OBJECTIVES:

* Determine whether loss of function of the FEZ1/LZTS1 gene is a predictor of response in patients with breast cancer treated with paclitaxel.

OUTLINE: This is a single-blind study.

Tumor tissue is analyzed for FEZ1/LZTS1 gene expression by immunohistochemistry using an antibody for the gene. Tumor expression of the gene is characterized by immunohistochemistry and scored by intensity of staining, percent of cell staining, and staining index. Tumor tissue is also analyzed for FEZ1/LZTS1 gene disruption by reverse transcriptase-polymerase chain reaction and direct sequencing.

PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Measurable disease

  * Metastatic disease identified by imaging studies OR a primary disease site that will be treated in a neoadjuvant protocol
  * Lesions ≥ 10 mm by spiral CT scan
* Tumor tissue from the primary or metastatic site available for analysis by immunohistochemistry
* Previously treated OR planning to undergo treatment with paclitaxel\* NOTE: \*Concurrent enrollment on ECOG-2100 allowed
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects

RPX7009 (beta-lactamase inhibitor) is being studied in combination with a carbapenem (RPX2014) to treat bacterial infections, including those due to multi-drug resistant bacteria.

The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the recent dissemination of a serine carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.

Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2014) plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics of intravenous RPX2014 and RPX7009, administered alone and in combination, in healthy adult subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult males and females, 18 to 55 years of age (inclusive) at the time of screening.
2. Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
3. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, ECGs, physical examination) as deemed by the PI.
4. Non-tobacco/nicotine-containing product users for a minimum of Dose Study 6 months prior to Day 1.
5. Voluntarily consent to participate in the study.
6. Sexually abstinent or agree to use two approved methods of contraception.

Exclusion Criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
2. Positive urine drug/alcohol testing at screening or check-in (Day -1).
3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
4. History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
5. Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
6. Blood donation or significant blood loss (i.e., \> 500 mL) within 56 days prior to Day 1.
7. Plasma donation within 7 days prior to Day 1.
8. Participation in another investigational clinical trial within 30 days prior to Day 1.
9. Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).
Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms

The purpose of this study is to determine whether waveforms of the intracardiac electrograms, acquired through an ICD, can be used:

* to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and
* to predict progression of heart failure in patients with ICD.


Eligibility Criteria:
Inclusion Criteria:

* history of acute MI at least 4 weeks old
* non-ischemic LV dysfunction for at least 9 months
* who have an EF \< or = to 35%
* who was resuscitated from sudden cardiac arrest (ventricular tachyarrhythmia)
* undergone implantation of an FDA-approved ICD for primary or secondary prevention of SCD

Exclusion Criteria:

* inability or unwillingness to provide valid informed consent
* pregnancy
* any condition other than cardiac disease that was associated with a high likelihood of death during 1 year after enrollment
Early PE for Autoimmune Encephalitis

Plasma exchange (PE) is one of the first-line therapies for autoimmune encephalitis (AE) patients, but the optimal timing of PE remains unclear. The study is tocompare the efficacy between early PE and late PE in patients with severe antibody-associated autoimmune encephalitis (AE).

Patients with AE will be randomly divided into the early PE group and late PE group according to the random table. All patients will receive tumour screening, symptomatic supportive treatment, and immunotherapy. The immunotherapy includes intravenous methylprednisolone (IVMP), intravenous gamma immunoglobulin (IVIG; 0.4 g/kg/d for each course for 5 d), PE and immunosuppressants. Patients in the early PE group received PE and IVMP treatment without delay, followed by IVIG immediately after PE treatment. Patients in the late PE group were given IVIG (0.4g/kg/d for 5 days) and IVMP immediately, followed by PE at least 2 weeks after IVIG treatment. The patients received long-term immunotherapy involving a combination of oral corticosteroids and immunosuppressants (such as mycophenolate mofetil at a dose of 1-2g/d) for 6-12 months if no contraindications. The primary outcome is the proportion of patients achieving functional improvement \[a decrease of at least 1 point in modified Rankin Scale (mRS) score\] at 3 months after immunotherapy.

Eligibility Criteria:
Inclusion criteria:

1. 14-65 years old;
2. met all the three following diagnostic criteria of AE: (i) subacute onset (rapid progress of less than 3 months) of working memory deficits, altered mental status, or psychiatric symptoms; (ii) at least one of the followings: new focal CNS findings, seizures not explained by a previously known disease, cerebrospinal fluid (CSF) pleocytosis (white blood cell count 5 cells/mm3), magnetic resonance imaging (MRI) features suggestive of encephalitis, and (iii) reasonable exclusion of alternative causes;
3. the presence of antibody in serum or CSF indicating a positive diagnosis of AE using a cell-based assay;
4. critically ill with a modified Rankin scale (mRS) score of 4 to 5;
5. within 3 months of onset;
6. no immunotherapy previously.

Exclusion criteria:

1. relative contraindications of TPE treatment: serious underlying diseases such as severe active hemorrhage, disseminated intravascular coagulation, severe hypotension or shock, unstable cardiac failure, cerebral herniation, severe infection or other endangered conditions;
2. allergic to immunoglobulin;
3. contraindications of glucocorticoid therapy: glucocorticoid allergy, active gastric or duodenal ulcer, severe osteoporosis, diabetes, hypertension after recent gastrointestinal anastomosis, and serious infection that cannot be controlled by antibiotics;
4. serious underlying diseases, such as cardiac dysfunction, arrhythmia, and coagulation disorders;
5. premorbid mRS ≥ 3.
Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults

The purpose of the CliniMACS® TCRαβ-Biotin System and CliniMACS® CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCRα/β+ and CD19+ cells using the CliniMACS® TCRαβ/CD19 System in children and adults with hematological and non-hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. Age \< 60 years and \> 1 month;
2. Life expectancy \> 10 weeks;
3. Patients deemed eligible for allogeneic HSCT per institutional guidelines;
4. Patients with life-threatening hematological malignancies and non-malignant disorders that could benfit from HSCT;
5. A minimum genotypic identical match of 5/10 is required;
6. The donor and recipient must be identical, as determined by high resolution typing, in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA-DRB1;
7. Lansky/Karnofsky score \> 50;
8. Signed written informed consent;
9. Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any chronic GvHD.

Exclusion Criteria:

1. Pregnant or lactating females;
2. Greater than Grade II acute GvHD or severe, unmanaged chronic extensive GvHD due to a previous allograft at the time of inclusion;
3. Dysfunction of liver (ALT/AST \> 10 times upper normal value, or direct bilirubin \> 3 times upper normal value), or unmanageable dysfunction of renal function;
4. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction \< 30%);
5. Current active infectious disease (including positive HIV serology or viral RNA);
6. Serious concurrent uncontrolled medical disorders;
7. Lack of patient's/parents'/guardian's informed consent;
8. Any severe concurrent disease which, in the judgement of the sponsor-investigator, would place the patient at increased risk during participation in the study.
Using New Ultrasound Techniques to Assess Peritoneal Fibrosis in Peritoneal Dialysis Patients

Explore the role of new ultrasound techniques in the assessment of peritoneal fibrosis and encapsulating peritoneal sclerosis in peritoneal dialysis patients


Eligibility Criteria:
Inclusion Criteria:

* ESRD patients on PD
* PD duration ≤12 months or ≥10 years
* Age between 18-75years

Exclusion Criteria:

* Refusing to sign up informed consent
Spinal Cord Injury Registry - North American Clinical Trials Network

The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting de-identified data from patients admitted through the Emergency Department of a NACTN center at the time of injury with an initial (first time) spinal cord injury (SCI). Information will be collected on the natural history of SCI and course of treatment through the first 12 months from the date of injury or long as medically indicated. Data collected includes imaging information from CT or MRI scans, neurological and general medical outcome and rehabilitation evaluation. No intervention is given other than standard of care for spinal cord injury, intensive monitoring and frequent follow up care.

The participating centers include:

University of Texas Health Science Center, Houston; University of Toronto, Toronto; University of Virginia, Charlottesville; University of Louisville, Louisville; University of Maryland, Baltimore; Walter Reed National Military Medical Center, Bethesda; Thomas Jefferson University, Philadelphia; University of Miami, Miami; Brooke Army Medical Center, Fort Sam Houston; Louisiana State University Health Sciences Center, New Orleans; Vanderbilt University Medical Center, Nashville; Medical College Wisconsin, Milwaukee; Duke University, Durham

The NACTN Clinical Coordinating Center is located at:

Houston Methodist Hospital, Houston

The Center for Biostatistics is located at:

Houston Methodist Hospital, Houston

The Data Management Center is located at:

University of Louisville, Louisville

Preliminary work has been completed on the selection of data elements, data collection protocols, case record form design, and the design of a computer system for clinical data management and data quality control.

In the first phase of the network, data will be collected on the natural history of SCI. Although there is considerable data in the literature about the natural history of SCI, current changes in treatment appear to be modifying the natural history. In particular very early surgery, including decompression of the spinal cord and vertebral stabilization with instrumentation appears, in some cases of SCI, to be improving outcomes.

No treatment is given other than standard of care for SCI. Data is collected in hopes to help SCI patients in the future.

Eligibility Criteria:
Inclusion Criteria:

* Any patient male or female \> or equal to 18 years of age with first time spinal cord injury caused by trauma and has neurological deficit with paralysis (weakness) or loss of sensation (touch).
* Has not received prior medical of surgical care for this injury at an intermediate hospital.
* Must give informed consent

Exclusion Criteria:

* Any patient or family refusing consent
SARS-CoV2 (COVID-19) Diagnosis in Human Saliva by MALDI-TOF MS Profiling

Since March 2020, SARS-CoV2 virus (nCoV19; COVID-19) is considered pandemic. Its high rate of spread and infection in the human population and the lack of effective and validated treatment have led the authorities of several countries to confine their populations to slow the spread of COVID-19. As part of the management of this health crisis, the screening of individuals is essential in order to isolate "infected cases". These screening tests are currently performed on nasopharyngeal swabs using RT-PCR for the detection of viral RNA. Although sensitive and specific, these tests remain relatively long (2-5 hours), expensive and the strong international demand for nucleic extraction kits and enzymes are factors limiting the implementation of widespread screening (problem of supply of swabs, molecular biology consumables).

In order to prevent the risks of a shortage of screening means, we propose to develop an innovative alternative strategy, PCR-free, based on the detection of specific protein signatures in human saliva by MALDI-TOF MS profiling. MALDI-TOF MS profiling is a method used in routine diagnostics by microbiology laboratories for the identification of microorganisms. MALDI-TOF MS profiling has been successfully used to classify individuals according to their infectious status (oral pathologies) based on the analysis of their saliva, but also as a tool for the identification of respiratory viruses from cell culture supernatants. In addition, we have expertise and skills in the field of MALDI-TOF MS profiling and have implemented new strategies to improve the quality of profiles and their analysis, particularly in the context of entomological and vector identification projects. Finally, recent Chinese studies have reported that COVID-19 was detectable in saliva by RT-PCR.

The main objective of this study is to develop a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age;
* screened for SARS-CoV2 by RT-PCR from a nasopharyngeal swab within 96 hours prior to inclusion.

Exclusion Criteria:

* Patient admitted to intensive care;
* Pregnant woman.
INSPIRE Turkey :A Research Study Looking at the Clinical Parameters Associated With Use and Discontinuation of Saxenda® in Local Clinical Practice in Turkey by Analysing Past Patient Medical Records

The study is investigating the use of Saxenda (liragltuide 3.0 milligrams (mg) once daily) for weight management. The primary objective is to investigate the change in body weight after initiation and use of Saxenda ® according to local clinical practice for weight management, on adult participant's in a real world setting in Turkey. The study will last for about 5 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have signed consent before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Patients who have polyclinic visits between 01 June 2022 and 31 October 2022 and who have received initial prescription of Saxenda® for weight management at least 52 weeks prior to study enrolment.
* Patients who have maintained treatment with Saxenda® for at least 16 weeks, without treatment break, following the initial prescription.
* Patients who have 12-month follow-up data, even if discontinued Saxenda ® treatment.
* Patients who have body weight measurement at baseline and at least 1 more body weight measurement following the Saxenda® prescription
* Age greater than or equal 18 years at the time of signing informed consent

Exclusion criteria:

* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Patient charts lacking any follow-up information for at least 16 weeks.
* Patients who have been treated with anti-obesity medication for last 12 weeks prior to initiation of Saxenda® treatment.
* Patients who receive GLP-1 receptor agonist for treatment of Type 2 diabetes.
* Patients who have undergone bariatric surgery or use of minimal-invasive weight loss devices (i.e. intragastric balloons, lap bands) within 1 year before starting Saxenda® treatment.
Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions and Restenosis From Prior Endovascular Procedures in This Sector.

The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting balloon luminor 14 \& luminor 35 in the treatment of infrainguinal occlusive lesions (superficial femoral artery (SFA), popliteal artery (PA) and tibial arteries (ATs)) and restenosis from prior endovascular procedures in this sector.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes aged at least 18
* Primary injuries and restenosis of the infrainguinal sector of AFS, AP and ATs, and intrastent restenosis or post-ATP prior in that sector.

  * Stenosis \>50% and occlusions. (image test)
  * Length: 20 to 200 mm
  * Artery diameter: 2-7 mm.
* Symptomatic patients (grades 2-5 Rutherford-Baker both included; Fontaine II-IV), affected in their quality of life and that accept treatment (moderate / severe claudication patients, critical ischemia without gangrene or injuries severe enough to foresee limb amputation).

Exclusion Criteria:

* Patients with acute or subacute ischemia will be excluded.
* Existence of flow-limiting lesions in arteries of the "in flow" or the "out flow" of the sector or artery under treatment (\> 50 % of the arterial diameter).
* Aneurysmal dilatation in the ipsilateral arterial axis.
* Intolerance / allergy to heparin, thienopyridine derivatives (clopidogrel , ticlopidine) and aspirin.
* Hemorrhagic diathesis during the 3 months prior to inclusion.
* Patients with a life expectancy of less than 12 months.
* Serious allergy to contrasts or PTX.
* Inability to cross the lesion with the guide (these cases will be recorded for the analysis as "intention to treat).
* Those participating simultaneously in another clinical trial.
* Pregnancy or lactation (pregnancy tests on fertiles).
Turkish Acquired Haemophilia Registry

Turkish Acquired Haemophilia Registry is a database in which information about clinical features and therapeutic management of acquired haemophilia is collected in Turkey.This is a multicentre, retrospective and prospective registry of subjects diagnosed and/or treated for acquired haemophilia. Patients will be registered and the response to different therapies, details of each bleeding episode and the outcome of haemostatic and immunosuppressive therapy (IST) will be recorded. Any male or female subject diagnosed with inhibitors to FVIII or other factors and treated for acquired haemophilia can be entered on the registry. Patients will be treated according to local practice. No additional tests or procedures are required by the registry. The retrospective period will not be time-limited and data will be collected from those recorded in the hospital notes. The prospective period will begin in September 1.2011, and will last for two years.


Eligibility Criteria:
Inclusion Criteria:

* Acquired haemophilia diagnosis, written consent

Exclusion Criteria:

* Being unable to give written consent