cyrilzakka/clinical-trials huggingface dataset:
Effect of Early Administration of Albumin 20% Versus Crystalloid

Sepsis and septic shock are global health problems, leading to a high mortality rate. They are often associated with extremely low blood pressure and multiple organ dysfunctions, which are the main causes of death in critically ill patients. Fluid resuscitation is one of the most critical treatments for patients with sepsis and septic shock.

An early administration of an appropriate fluid to patients is considered the most effective way to increase blood pressure, improve tissue perfusion, and save their lives. Crystalloid fluids are a subset of intravenous solutions composed of mineral salts and other small, water-soluble molecules, including normal, isotonic or hypertonic saline, and various buffered solutions.

Crystalloid fluids are a subset of intravenous solutions composed of mineral salts and other small, water-soluble molecules, including normal, isotonic or hypertonic saline, and various buffered solutions.

Colloid solutions are composed of various amounts of substances, for instance, albumin, hydroxyethyl starch, dextran, and gelatine. Although the current international guidelines from the Surviving Sepsis Campaign recommend crystalloids to perform the initial resuscitation, and the replacement with albumin on patients who require substantial amounts of crystalloids, the choice of the best type of resuscitation fluids is still under debate.

Albumin, in addition to its oncotic functions, has a variety of other properties, including binding and transport of various endogenous molecules, anti-inflammatory and anti-oxidative effects, and modulation of nitric oxide metabolism.These properties are particularly relevant in critically ill patients, especially in patients with sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Presence of septic shock that meets all the following Criteria: Clinically possible, probable, or microbiologically confirmed infection according to the definitions of the International-Sepsis- Forums (ISF), Despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (MAP) ≥ 65 mmHg for at least 1 hour, Serum lactate concentration \> 2 mmol/l (18 mg/dl) despite adequate volume therapy.
* Onset of septic shock less than 24 h prior to study inclusion.
* Women of childbearing age: negative pregnancy test

Exclusion Criteria:

* Moribund conditions
* End of life decisions
* Previous participation to this trial or any other interventional clinical trial
* Known hypersensitivity to albumin or any component of the trial drug
* Clinical conditions, where albumin administration may be unfavourable
* Breast feeding
Iron Interventions and Non-transferrin-bound Iron (NTBI) in Women

The overall goal of this research is to develop safe and effective iron interventions that can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in the systemic circulation not bound to the iron-transport protein transferrin). The appearance of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after oral administration of iron supplements in doses similar to those used in the Pemba trial. This research project will (i) confirm the appearance of plasma non-transferrin-bound iron after administration of an iron supplement like that in the Pemba trial (\~1 mg Fe/kg body weight, without food), and then determine the effects on production of plasma non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of giving the supplemental iron (\~1 mg Fe/kg) with the standard rice meal, and (iii) of giving a lower dose of iron (\~0.1 mg Fe/kg) - like that used in home fortification - with the standard rice meal.


Eligibility Criteria:
Inclusion Criteria:

* non pregnant
* non lactating
* apparently healthy women

Exclusion Criteria:

* chronic disease
* pregnancy
* lactation
Comparison of a Spectral OCT/SLO With the Stratus OCT for Imaging Various Retinal Pathologies

The purpose of this study is to compare the newly released Spectral OCT/SLO (OTI, Toronto, Canada) with the Zeiss Stratus OCT (Carl-Zeiss Meditec, Dublin, CA) with regards to the quality of the images obtained as well as the ease of use.


Eligibility Criteria:
Inclusion Criteria:

* N/A

Exclusion Criteria:

* N/A
Enzastaurin For Breast Cancer Patients Who Previously Received an Anthracycline and a Taxane Chemotherapy

The purpose of this study is to determine the effectiveness of enzastaurin in the treatment of patients with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of metastatic breast cancer or recurrent breast cancer where surgery can not be done for curative intent
* Have received prior therapy with an anthracycline (class of drugs) and a taxane (class of drugs).
* Tumors must not be positive for HER2, but if positive, the treatment plan should not include further treatment with the drug Herceptin.
* Disease that can be definitely measured on Cat Scans or other radiological tests.
* May have received high dose chemotherapy for autologous stem cell support greater than or equal to 6 months of starting this study.

Exclusion Criteria:

* More than 2 chemotherapy regimens for metastatic or locally recurrent disease.
* Have brain cancer from breast cancer
* Pregnant or breastfeeding
* Have an inability to swallow tablets
* Within 6 months have had a serious heart condition
Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study

The study investigated the perceived-mobility of patients with unilateral lower limb amputations by means of patient-reported outcome measures (PROMs). Such aspect may play an important role in evaluating the patient impairment and addressing forensic-medical issues. However, to this concern, the use of PROMs has not been extensively investigated yet. Among the validated PROMs, the study assessed self-perceived mobility and quality of life by administering the Trinity Amputation Prosthetic Evaluation Survey (TAPES) and the more recent Prosthetic Mobility Questionnaire (PMQ). The aim of this observational study was to improve the estimation of the physical and psychological impairment caused by the amputation, focusing on the impact of the limb loss on social participation, quality of life and daily living activities.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 and 65 years
* Unilateral trans-femural or trans-tibial amputation
* Experienced prosthesis users (at least two years)
* Subjects that provided written informed consent to study participation and data publication

Exclusion Criteria:

* Severe comorbidities
* Psychological impairment
* Pregnancy
* Patient not collaborative
Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial

The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective diet plan to reduce cardiovascular risk factors of new cardiovascular events.

Cardiovascular diseases are the leading cause of mortality in both sexes in Brazil and worldwide. Modifying risk factors such as diet and lifestyle can prevent most cases of cardiovascular disease. This pilot trial is based on specific and traditional brazilian food. The objective is to reduce risk factors such as obesity, high blood pressure,dyslipidemia and diabetes in patients with cardiovascular disease history.

Eligibility Criteria:
Inclusion Criteria:

* Any coronary artery disease evidence in the past 10 years; or any ischemic stroke or TIA evidence in the past 10 years; or peripheral arterial disease in the past 10 years; or at least one of the following additional risk factors:
* Diabetes Mellitus; Hypertension; Dyslipidemia; Coronary artery disease family history;
* Asymptomatic carotid artery disease;
* Body mass index\> 25 kg/m2 for adults and\> 28 kg/m2 for seniors

Exclusion Criteria:

* Neurocognitive or psychiatric condition;
* Life expectancy less than 6 months (eg, metastatic malignancy or other defined as clinical trial investigators).
* Pregnancy or breast feeding.
* Hepatic impairment defined as elevated liver enzymes above three times the upper limit of normal
* Renal impairment defined as creatinine values higher than 1.5 mg/dL.
Breath Analysis in Obstructive Sleep Apnoea

Clinical trial in patients with obstructive sleep apnoea that are randomised to either continue or withdraw continuous positive airway pressure therapy to identify a disease-specific exhaled breath pattern by mass spectrometry.

Randomised placebo-controlled trial (therapeutic vs. subtherapeutic continuous positive airway pressure \[CPAP\]) including 30 OSA patients to define the effects of CPAP withdrawal (subtherapeutic CPAP) on the composition of exhaled breath analysed by mass spectrometry for identification of OSA specific markers.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) of \>20/h.
* Currently \>20/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed on the last night of a 4-night period without CPAP.
* Treated with CPAP for more than 12 months, minimum compliance 4h/night, apnoea-hypopnoea index (AHI) \<10 with treatment (according to CPAP- download) and current ESS \<10.
* Age between 20 and 75 years at trial entry.

Exclusion Criteria:

* Previous ventilatory failure (awake SpO2 \<93% and PaCO2\>6kPa).
* Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (\>180/110 or \<90/60mmHg)
* Previously diagnosed with Cheyne-Stokes breathing.
* Current professional driver; any previous sleep related accident.
* Acute inflammatory disease.
* Acute or chronic hepatic disease.
* Renal failure or renal replacement therapy.
* Use of inhaled drugs.
Carboplatin, Abraxane, Avastin as Neoadjuvant Therapy for Her2-Negative Breast Cancer

In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in HER2(-) patients was 20%. The investigators' goal is to develop an induction chemotherapy regimen that will have a pCR rate above 30% in patients with HER2(-) disease. Based on a 1-sided 95% confidence interval using normal approximation with an expected pCR rate of at least 35%, approximately 28 patients are required for each cohort. With an assumed pCR rate of at least 35%, the investigators will have approximately 70% statistical power to conclude, with 90% certainty, that the pCR rate with the novel regimen exceeds 20%. The study will accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed 10%.

See above brief summary

Eligibility Criteria:
Eligibility criteria

Inclusion criteria:

* Histologically documented adenocarcinoma of the breast
* ANC \> 1000 cells
* Female; age \> 18
* Zubrod PS 0-1
* Platelets \> 100,000
* Stage IIA-IIIB disease
* Total bilirubin \< 1.5 ULN
* No evidence of any metastatic disease
* Serum Creatinine \< 1.5 gm/dl
* No prior systemic therapy for breast cancer or Creat Cl \> 30 ml/min
* Not pregnant or lactating
* Serum ALT \< 2.0 ULN
* ER, PR and HER2 status required
* LVEF (MUGA/echo WNL)
* No baseline \> 2 neuropathy
* Urine protein: creat ratio \< 1.0
* HER2-negative - either IHC 0-1+ or FISH ratio \< 2.0
* Hemoglobin \> 9 gm/dl
* (FISH testing is required for all HER2 2-3+ tumors by IHC)

Exclusion criteria:

* No Histologically documented adenocarcinoma of the breast
* No-ANC \> 1000 cells
* Female; age \< 18
* Zubrod PS \> 0-1
* Platelets \< 100,000
* Stage IV disease
* Total bilirubin \> 1.5 ULN
* metastatic disease
* Serum Creatinine \> 1.5 gm/dl
* prior systemic therapy for breast cancer or Creat Cl \> 30 ml/min
* pregnant or lactating
* Serum ALT \> 2.0 ULN baseline \> 2 neuropathy
* Urine protein: creat ratio \>1.0
* HER2-positive
* Hemoglobin \< 9 gm/dl
Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer

GERICO is a randomized, controlled prospective trial. The aim is to investigate if frail, elderly patients with stage II-IV colorectal cancer, will profit from full comprehensive geriatric assessment and intervention before and during treatment with chemotherapy.

The hypotheses are: Optimizing the health conditions and functional status of frail elderly patients who suffers from stage II-IV colorectal cancer, with geriatric intervention will lead to a higher grade of completing the planned chemotherapy and at higher dose intensity. This will also result in a higher overall survival and improve quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Frail according to the screening tool G8 ( ≤14 / 17points)
* Performance status 0-2 and life expectancy ≥ 3 months
* Patients who have undergone surgery for stage III / high-risk stage II colorectal cancer or patients with unresectable or metastatic disease
* Are assessed to receive adjuvant chemotherapy or first -line chemotherapy
* Meets the criteria to receive preventive chemotherapy with 5-FU or capecitabine +/- oxaliplatin or first -line chemotherapy with 5-FU / irinotecan and / or oxaliplatin , capecitabine +/- possibly with the addition of immunotherapy in the form of cetuximab , panitumumab or bevacizumab.
* Informed written and oral consent

Exclusion Criteria:

* Other malignancy except basal cell carcinoma and squamous cell carcinoma in situ cervicis uteri in 5 years
* Patients in simultaneously drug trials
* The patient must not have previously received adjuvant chemotherapy in the GERICO Protocol
Study for Identifying Optimal Simvastatin Formulation for Uniform Time to Maximum Plasma Concentration

The inter- and intra-variability in the pharmacokinetic parameters of different formulations and doses of simvastatin in healthy subjects and in subjects with celiac disease in remission will be evaluated. Additionally, baseline values of pharmacokinetic parameters of simvastatin for both study groups will be determined.


Eligibility Criteria:
Inclusion criteria:

* If the subject is female, she is eligible to enter and participate in this study if she is physiologically incapable of becoming pregnant or has a negative urine pregnancy test at screening and at baseline visit
* Negative Serology for Hepatitis B/C, HIV
* Non-OATP1B1\*5 carriers
* Negative Serology for anti-transglutaminase IgA antibody, and normal levels of total IgA
* For subjects with celiac disease, also

  * Diagnosis of celiac disease confirmed by medical history, histological evaluation of small intestinal mucosa on small bowel biopsy, and abnormal anti-transglutaminase antibody titers
  * Followed a gluten-free diet for at least one year, as verified by normal anti-transglutaminase antibody levels, Marsh 0-1 score on a follow-up biopsy within the past 12 months, and absence of any clinical signs or symptoms of celiac disease observed at diagnosis

Exclusion criteria:

* Current smoker or quit smoking less than 2 years ago
* Female breastfeeding or disagrees to use an effective mechanical contraceptive method (e.g. diaphragm or nonhormonal intrauterine device in combination with preservative)
* Presence of any known on-going disease which is judged to be relevant according to the investigator, besides celiac disease for the cohort of celiac patients in remission
* State after operations of the stomach or bowel (exception: appendectomy)
* Participation in any other clinical trial with investigational or approved drugs within the last month before the study
* Regular alcohol consumption of more than 25 g / day
* Use of any prescription or non-prescription drugs (including herbal supplements) must be discontinued 30 days prior to study (exceptions: paracetamol and NSAIDs, not taken longer than 2 days in a row and not taken within the last 3 days before the study)
* Consumption of grapefruit, star fruit, grapefruit juice, or star fruit juice must be discontinued 7 days prior to the study
Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

Better management and improving outcome of children with allergic rhinitis

The prevelance of Allergic Respiratory Diseases has been increased worldwide and affect 1of 5 persons of general population . ARDs are triggered by exposure to allergen and includes allergic rhinitis with or without conjunctivitis and bronchial asthma. ARDs are associated with decreased quality of life and increased economic burden .

Allergen-specific immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma, and its efficacy has long been known since observations by Leonard Noon in 1911. Allergen immunotherapy for AR is currently considered when showing strongly suggestive symptoms of AR which interfere with daily activities or sleep, and having evidence of IgE sensitization to ≥1 clinically relevant allergen .

The European Academy of Allergy and Clinical Immunology (EAACI) recommends treatmentof children with moderate to severe AR with Allergen Immunotherapy. It includes sublingual immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT).Subcutaneous immunotherapy (SCIT) has been the gold standard, whereas sublingual immunotherapy (SLIT) has emerged as an effective and safe alternative .

Sublingual immunotherapy (SLIT) is the only treatment that regulates the immunological process during development of allergic rhinitis (AR), rather than simply treating symptoms.

Platelet activation occurs during antigen-induced airway reactions in allergic and asthmatic subjects. Raised levels of platelet-derived mediators, such as the Platelet Factor-4 (PF4), it is observed in plasma and bronchoalveolar lavage fluid of atopic individuals, and has the ability to activate eosinophils, increase expression of Fc-IgG and Fc-IgE receptors, and stimulate basophils to release histamine.

Eligibility Criteria:
Inclusion Criteria:

* 1. Children with moderate to severe allergic rhinitis according to Allergic Rhinitis And Its Impact On Asthma (ARIA) guidelines\[9\], which interfere with daily activity or sleep.

  2. Children aged (6-12) years with clinical history of allergic rhinitis for at least one year.

  3. Children with allergic rhinitis who failed medical treatment, desire an alternative to pharmacotherapy.

  4. Sex : male and female.

Exclusion Criteria:

- 1. Children with chronic lung \& heart diseases as: asthma and anatomical malformation for respiratory system.

2. disorders: Gastro Esophageal Reflux Disease, cystic fibrosis and epilepsy. 3.Children with chronic drug use: oral or nasal corticosteroids, antiepileptic and immunosuppressive.
Early Connections, Early Detection and Intervention in Infants at Risk for Autism

Early connections has two broad goals:

* to identify risk indices for autism spectrum disorder (ASD) in 6 to 24 month old infants who have an older sibling with ASD or infants who have an older neurotypical sibling.
* to assess whether it is possible to alter risk processes through early intervention with high-risk infants, thereby reducing social-communication delays or the severity of autism symptoms.

Researchers at the University of Washington want to learn more about the benefits of early monitoring and intervention for younger siblings of children with autism spectrum disorders (ASD). The information gained in this study may improve methods of early detection and intervention for infants who may be at risk for developing autism and lead to better outcome for these young children and their families.

Participants include families with a child who has been diagnosed with an autism spectrum disorder or typical development and a younger sibling 12 months old or younger. The study protocol includes: (1) comprehensive infant evaluations at the University of Washington Autism Center at 6-months, 12-months, 18-months and 24-months of age. (2) Developmental screening for the older sibling. (3) Questionnaires and phone interviews for parents. (4) Random assignment to an assessment and monitoring intervention group or a University of Washington intervention group. All families will receive advice regarding appropriate intervention services. Families who are assigned to the UW intervention will take part in a parent delivered intervention.

Eligibility Criteria:
Inclusion Criteria:

* Older sibling with ASD (biologically related to participant)
* Participant 12 months of age or younger
* Within 1 hour of University of Washington
* Interested in participating in Intervention

Exclusion Criteria:

* Out of study area
* Serious parent substance abuse or psychiatric history
* Diagnosis of known genetic syndromes or neurological conditions (infant participant or older sibling)
* Serious motor impairment (infant participant)
* Significant prematurity (infant participant)
Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention

Radial artery is the recommended route for percutaneous coronary intervention for it significantly reduces net adverse clinical events compared to the femoral approach. The success of the radial approach is therefore of a paramount importance. However, radial artery spasm (RAS) remains one of the major limitations of transradial approach (TRA) and the most frequent cause of TRA failure. Several recommendations has been issued to improve success rate when using the radial route.

In the Tunisian difficult economic context, the use of low end equipment, the unavailability of nitroglycerine and calcium antagonist verapamil, has led to the general feeling that RAS and TRA failure has subsequently increased.

The standard and only used protocol by the Tunisian interventional cardiologist, consists of administrating 1 mg isosorbide dinitrate through the arterial sheath immediately after radial arterial puncture, therefore limiting the options to prevent RAS.

Nicardipine is the only injectable calcium antagonist available in Tunisia. Its spasmolytic action on radial artery has been well demonstrated when used in CABG. However, it has been very poorly investigated in trans radial percutaneous coronary intervention.

Investigators believe that the concomitant use of nicardipine with isorbide might significantly reduce RAS and TRA failure when compared to isosorbide dinitrate only.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for coronary intervention will be eligible for screening (coronarography or coronary angioplasty).
* Participant is willing and is able to give informed consent for participating in the trial.
* Male or Female, aged 18 years or above.

Exclusion Criteria:

* Planned femoral approach because no radial pulse was perceived
* Cardiogenic shock
* Coronary intervention for ST elevation myocardial infarction during the night shift.