cyrilzakka/clinical-trials huggingface dataset:
Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain

ECOS is a cross-sectional, observational, longitudinal, multicenter study enrolling 100-200 patients during a COPD exacerbation.

Patients will be followed for 12 months. Information to be collected includes clinical, analytical, immunological, microbiological, hemodynamic, imaging, environmental, social and other blood markers of inflammation (IL-8, IL-6, TNF, TNF-alpha, endothelin-1, SLPI, IL10, TGF-beta and markers oxidative stress (TEAC)), and sputum (cell count, IL-6, IL-8, SLPI, ET 1, IL10).

Each center will collect clinical data, blood gas, microbiological and functional data for their patients, which will be centralized through the website of the Red Respira (www.redrespira.net).

A frozen serum sample and another of frozen sputum supernatant will be sent to the coordinating center (Palma de Mallorca).

Statistical analysis will include descriptive statistics: mean, standard deviation and range. Comparison of quantitative variables to be assessed using Student's t-test and ANOVA. Correlations between variables will be performed using bivariate analyzes (Pearson's linear correlation coefficient) and multivariate (multiple regression) analyses, among others.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Ages 40-80 years
* Diagnosis of COPD (according to ATS/ERS consensus guidelines)
* Smoking history ≥ 10 pack years
* Hospitalization for exacerbation of COPD

Exclusion Criteria:

* Pneumonia.
* Pneumothorax.
* Severe comorbidities, such as:
* -Advanced cancer.
* -Pulmonary tuberculosis, which affects more than one third of the total lung parenchyma.
* -Pneumonectomy.
* -Previous diagnosis of left heart failure.
* -Cardiomyopathy with ventricular dysfunction (ejection fraction \<45%).
* -Chronic inflammatory diseases such as asthma, rheumatoid arthritis, pulmonary fibrosis and autoimmune diseases.
* Mechanical Ventilation.
* Existence of an exacerbation of COPD in the 4 weeks prior to admission.
* MRSA.
* History of thoracic/lung surgery in the past two years
* General weakness/malaise (difficulty in walking, lack of autonomy, etc.). that substantially hinders participation in the study, regardless of their willingness to participate.
* Mental incapacity according to the investigator judgment.
* Not resident in the province in which the hospital is located.
* Not fluent in Spanish
* Allergy to iodinated contrast
* Morbid obesity (BMI\> 40)
Peripartum Bacteruria and Urinary Tract Infections (UTI)

In the last years urinary tract infections (UTI) and pyelonephritis have been the most common reason for readmission to our hospital after birth. UTI is know to be one of the leading causes of postpartum fever affecting about 3%-8% of all postpartum women.

The investigators hypothesize that collecting urine cultures pre- and postnatally may help identify women at risk for developing UTI, while treating women with positive cultures could decrease the rehospitalization rate due to postpartum fever. Collecting data during delivery may help identify women at risk for this complication.

The study is planned as a randomized controlled study with 500 women in each arm. The study group will have pre and post labor urine cultures taken, and the risk factors during delivery will be documented, while the control group will have no cultures taken, as the common practice prior to the study.

Women with positive cultures will be contacted by telephone, and antibiotic treatment recommended according to bacteria sensitivity. All women will be contacted by telephone 1 month post partum and data regarding urinary tract symptoms and need for hospitalization, will be collected. The rehospitalization rate will be documented and compared between the two groups.

The assumption is that routine urine culture to women in the peripartum period may reduce the UTI rate and hospitalization after delivery.

Eligibility Criteria:
Inclusion Criteria:

* Parturients planned for vaginal delivery

Exclusion Criteria:

* Parturients receiving antibiotic treatment during delivery or in the week before
Allopregnanolone for Mild Cognitive Impairment Due to Alzheimer's Disease or Mild AD

The purpose of this study is to evaluate the safety and tolerability of allopregnanolone, a naturally occurring brain steroid, in mild cognitive impairment and early Alzheimer's disease participants. The primary goal is to determine the maximally tolerated dose.

1) Each dose group will be comprised of 8 participants (6 randomized to allopregnanolone; 2 randomized to placebo) administered one dose of allopregnanolone or placebo once per week for 12 weeks. A higher dose will be administered to the next group of participants when the lower dose is shown to be safe and tolerable. 2) Pharmacokinetic analyses will be conducted on blood samples taken from participants at the beginning and end of the trial. 3) The trial will assess safety including via MRI brain imaging.

Eligibility Criteria:
Inclusion Criteria:

* Men or postmenopausal women
* 55 years of age or older
* Diagnosis of MCI due to AD or mild AD
* MMSE \> 20 at screen
* Capacity to provide informed consent
* Residing in the community with a caregiver able to accompany the patient to clinic visits
* No medical contraindications to participation
* Willingness to comply with study procedures

Exclusion Criteria:

* Use of benzodiazepines, sedative/hypnotics, anticonvulsants, antipsychotics, and other drugs that might interact with the GABA-A receptor complex
* Seizure disorder, history of stroke, focal brain lesion, traumatic brain injury, substance abuse, malignancy
* Clinically significant laboratory or ECG abnormality
* MRI indicative of any other significant abnormality, including but not limited to evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions
* Any condition that would contraindicate an MRI such as the presence of metallic objects in the eyes, skin, heart, or body
Citrulline and Arginase Activity in Severe Sepsis and Septic Shock

Sepsis is an acute pathology defined as an inappropriate response of the host to infection, resulting in the onset of organ failure (Quick SOFA ≥2, or SOFA ≥2). Septic shock is a sepsis associated with an elevation of lactate ≥ 2 mmol / l and an arterial hypotension requiring vasoactive drugs. Several studies highlighted that sepsis is associated with a plasma L-arginine deficiency. This deficiency induces a lower availability of L-arginine for multiple metabolic pathways including those involved in the synthesis of nitric oxide (NO) in the vascular endothelium via NO synthase. NO is the main endogenous vasodilator mediator, a lower synthesis induces a vascular and endothelial dysfunction that can promote the occurrence of an organic dysfunction during sepsis. Decrease in available NO was confirmed in patients with sepsis and appears correlated with severity.

L-arginine deficiency can have multiple origins:

* L-arginine deficiency resulting from a decrease in endogenous production from citrulline synthesized by the enterocytes. Such enterocyte dysfunction has been confirmed in patients with sepsis and is characterized biologically by elevated plasma levels of I-FABP (intestinal fatty acid binding protein - enterocyte-specific protein, cytolysis marker) and lower than that of citrulline (hypocitrullinemia, marker of lower activity).
* L-arginine deficiency may also result from a catabolism increase via arginase activity increased. This ubiquitous enzyme, having 2 isoforms (Arg1 and Arg2), allows the synthesis of urea and ornithine from L-arginine. An increase in arginase activity would decrease the available reserves of L-arginine for NO synthesis.

The objectives of this work is to evaluate, in patients with severe sepsis or septic shock, the prognostic value of the plasma arginase activity and the plasma expression of 2 isoforms Arg1 and Arg2, their kinetics, and the link between activity / expression of arginase and enterocyte dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Patient admitted to ICU
* Diagnosis, suspected or confirmed, of severe sepsis or septic shock
* Expected ICU stay of at least 2 days
* Affiliation to a social security system or recipient of a such system
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Chronic intestinal pathology
* Chronic renal failure defined by creatinine clearance \<50 ml / min / 1.73m2 (CKD-EPI)
* Severe hepatic insufficiency (Child-Pugh stage C score)
* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
* Patient within the exclusion period of another study or planned by the "national file of volunteers"
Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure

The aim of this prospective, randomized study of Bulkamid treatment is to investigate the efficacy of Bulkamid treatment in women with urinary stress incontinence not suitable to TVT-procedure because of suspected ISD.

The aim of this prospective, randomized study is to investigate the effect of Bulkamid injection for women with urinary stress incontinence and not suitable to TVT-procedure because of suspected ISD and compare this treatment with no or traditional treatment. The primary endpoint for efficacy will be reduction of leakage during pad-test at 2 months compared with pad- test before injection.

Secondary endpoints will be patient satisfaction measured at both 2 and 12 months using a questionnaire and the number of side effects.

Eligibility Criteria:
Inclusion Criteria:

Ability to understand the information and to give informed consent.

* At least 50 years of age
* History of urinary leakage during low grade physical activity. A woman with genuine stress incontinence has urinary incontinence during running or jumping. Women with suspected ISD have incontinence at much lower grade of physical activity such as slow walking or standing up and just coughing. Walking, standing up from a chair, and coughing are regarded as low grade of physical activity.
* A positive pad-test (after coughing 10 times) with increase of minimum of 10 grams of urine with 300 ml in the bladder or a 24 h pad-test of more than 100 mg of urine
* No hypermobility of the urethra during cough test.
* Low pressure of the urethra (optional?)
* With a of average miction volume of minimum 150 ml and at least one volume of more than 250

Exclusion Criteria:

* Women with hypermobility of the urethra during coughing and positive Bonney's test
* Women suitable for a TVT procedure.
* Positive urinary culture
* Urge incontinence
Treatment of Head & Neck Cancer With Chemotherapy and Radiation

Two new cancer treatment drugs called targeted therapies will be added to standard treatment for head and neck cancer to see if an improvement can be made in the effectiveness of treatment for this type of cancer. Treatment will include chemotherapy, radiation therapy and targeted therapy taken over a period of 4 months.

In this trial, patients will receive induction treatment with combination chemotherapy(paclitaxel/carboplatin/infusional 5FU) plus bevacizumab. After 6 weeks of treatment, patients will be reevaluated and will then receive concurrent radiation therapy, chemotherapy (weekly paclitaxel),bevacizumab, and erlotinib.

Induction Treatment:

Paclitaxel 200mg/m2 by vein over 1-3 hours on Day 1 \& Day 22 Carboplatin AUC 6.0 by vein over 1 hour on Days 1 and 22 Bevacizumab 15mg/kg by vein over 60-90 minutes on Days 1 and 22 5-FU 200mg/m2 as a 24 hour continuous infusion via pump on Days 1 through 43.

Combined Modality Treatment:

Radiation therapy is given daily, Monday through Friday for approximately 7 weeks. Erlotinib 150mg by mouth daily during the entire course of radiation (approximately 7 weeks) Paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation therapy Bevacizumab 15mg/kg by vein over 30-90 minutes on Days 50 and 71 at the same time of radiation therapy

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed head \& neck cancer
* Considered low cure rate with local therapy
* No prior treatment for this cancer
* Able to be up \& about and perform self care
* Adequate renal and liver function
* Must be 18 years of age or older
* All patients will need an indwelling central venous access catheter
* Must be able to give written informed consent

Exclusion Criteria:

* Active cancer treatment in the last 5 years
* Pregnant or lactating women
* History of stroke, transient ischemic attacks, or acute myocardial infarction within the past 6 months or any other serious cardiovascular disease
* History of neurological disease
* Recent history of blood in the sputum or vomitus
* Non-healing wounds, ulcer or long bone fractures
* History of bleeding problems or coagulation problems
* History of abdominal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months
* History of uncontrolled hypertension
* Symptomatic peripheral vascular disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours

Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours.

This will be a non-randomized phase II trial with the objective of evaluating the clinical response rate of calcium electroporation treatment of malignant tumours of the skin and assessing treatment impact on quality of life. This study will investigate the response rate of calcium electroporation treatment of skin metastases and malignant wounds in a real-world setting, in three different cancer centres in Northern Europe. The centres aim to treat a total of 30 patients with cancer in the skin of any histology. The patients will be treated once and followed with regular examinations for 12 months, starting from first treatment day. All patients will have been offered the standard of care and all available alternatives before entering the protocol. Calcium electroporation will not be compared to other means of treatment.

The primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. A subset of patients will undergo MR scans after treatment and another subset of patients will be interviewed regarding treatment impact on quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Trial subject ≥ 18 years.
* Trial subject must be able to understand the participant information.
* Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
* The patient must have been offered other relevant standard treatment for their cancer disease.
* The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.) if progressive or stable disease is present after a treatment period of two months or more.
* The patient can undergo radiation therapy, provided that the treatment field does not involve treated area.
* Performance status ECOG/WHO ≤2.
* At least one cutaneous or subcutaneous tumour measuring up to 3 cm.
* Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch).
* Signed informed consent.

Exclusion Criteria:

• Pregnancy or lactation
Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care

The purpose of this study is to look at the long term safety profile of Orfadin treatment in patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study will use Orfadin according to normal clinical practice.

The planned study is a non-interventional study that will look at the long-term safety of Orfadin treatment in patients suffering from hereditary tyrosinemia type 1. Orfadin will be used according to normal practice . There is an ongoing post-marketing surveillance (PMS) program to monitor hepatic, renal, hematological, neurological and ophthalmic status in all patients treated with Orfadin. The Committee for medicinal Products for Human Use (CHMP) has required this program and have looked at the data for approximately 400 patients and found the benefit-risk ratio to be positive. The present study (PASS) will replace the ongoing PMS. The transition of countries will be gradual; starting in 2013.The study will include HT-1 patients on Orfadin treatment in standard clinical care as well as newly diagnosed patients just starting with Orfadin treatment.

Eligibility Criteria:
Inclusion Criteria:

* All HT-1 patients receiving Orfadin treatment are eligible for entry.

Exclusion Criteria:

* No exclusion criteria
Assessment of Siemens' GoBrain and DotBrain Software

Our main approach in this research is to collect MR data using both a "Routine" and "Fast" brain protocol on the 3 Tesla Siemens Skyra scanner using a 20-Channel Head/Neck Coil to determine if the "Fast" protocol can collect data in less time without compromising patient care.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for MRI with History of Headaches

Exclusion Criteria:

* Patient does not meet MRI safety criteria
* Patient has known Brain Pathology
Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus

Diabetes mellitus (DM) increases susceptibility to Tuberculosis (TB) and worsens TB patient outcomes. The number of patients with combined TB and DM now outnumbers that of combined TB and HIV and it has been estimated that 15-30% of TB disease may be attributable to diabetes globally. This may be expected to rise substantially as DM prevalence increases. Treatment of Latent TB Infection (LTBI) in this population will likely have a significant clinical benefit. Similar to HIV-infected individuals, those with DM might benefit from therapy to prevent the development of TB disease. Current international guidelines do not recommend LTBI management in people with DM, but this is because no studies have examined the risk-benefit ratio of such an intervention. To date, no RCTs have been conducted to investigate the efficacy and safety of preventive treatment of LTBI in DM patients. Based on evidence on effectiveness, safety, and treatment completion rates, 3HP has been selected as the regimen of choice for this study of African people living with DM. People living with DM will be randomized to 3HP or placebo to determine the efficacy of 3HP in the prevention of TB disease in this population. PROTID's preventive treatment of LTBI among people with DM will generate the first solid evidence to support or refute the use of preventive treatment against TB in people with DM.


Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in diabetes care with a history of DM and current use of anti-diabetic medication ('known DM'); OR in the absence of anti-diabetic medication an HbA1c of =6.5% (48 mmol/mol) or a fasting venous plasma glucose of =7.0 mmol (126 mg/dl). For those with no previously known DM a repeat test above the diagnostic cut-point is required to confirm the diagnosis ('new DM')
2. Adult (18 years or older)
3. Diagnosed with LTBI, defined as a positive IGRA test or TST reactivity =10 mm
4. Voluntarily signed Informed Consent Form
5. If sexually active, willing to use an effective contraceptive method for the duration of preventive therapy.

Exclusion Criteria:

1. Weight \<45 kg
2. Previous TB disease, defined as either bacteriologically confirmed or clinically diagnosed and treated
3. Treatment with a rifamycin medication or isoniazid in the previous 2 years.
4. Diagnosis of probable or definite TB during screening
5. Confirmed HIV-infection or receiving antiretroviral treatment
6. Liver dysfunction, defined as serum aspartate aminotransferase (AST) level 5 times the upper limit of normal
7. Pregnant or planning to become pregnant in the next 3 months, or lactating
8. Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
9. Other conditions inapplicable for participation in this study, such as likely to fail to adhere to study commitment or to complete the whole study, at the discretion of the site investigator
Health Effects of Early-Life Exposure to Urban Pollutants in Minority Children

A molecular epidemiologic study of African American and Hispanic mothers and newborns to investigate the role of common urban pollutants on procarcinogenic and developmental damage.

The major objective of the proposed research is to study the impact of early-life exposures to common urban pollutants on neurobehavioral development and asthma in a sample of children living in three low-income, minority communities of New York City (Central Harlem, Washington Heights and the South Bronx). Using a molecular epidemiologic approach with monitoring, biomarkers, and clinical assessments at serial time points, we will extend our study of African-American and Latina urban mothers and children in order to follow the cohort through child age 11 years to assess the longer-term impact of exposures on child health and developmental outcomes.

Eligibility Criteria:
Enrollment eligibility was restricted to nonsmoking pregnant women 18-35 years of age who self-identified as either African American or Dominican and who had resided in northern Manhattan or the South Bronx in New York City for at least 1 year before pregnancy. Women were excluded if they used illicit drugs, had diabetes, hypertension, or known HIV, or had their first prenatal visit after the 20th week of pregnancy.
Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil

The present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult survivors of hospitalization for COVID-19. Adult patients requiring hospitalization due to COVID-19 disease will be followed through structured and centralized telephone interviews performed at 3, 6, 9 and 12 months after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Symptomatic COVID-19 disease within the last 14 days;
* Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within the last 14 days;
* Need of hospitalization (duration ≥ 48 hours).

Exclusion Criteria:

* Severe comorbidity with life expectancy less than 3 months;
* Death during hospitalization;
* Absence of telephone contact;
* Absence of proxy for patients with communication difficulties;
* Refusal or withdrawal of agreement to participate;
* Previous enrollment in the study.