cyrilzakka/clinical-trials huggingface dataset:
A Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes

The purpose of this study is to study the biomarkers in subjects before and after sports-induced traumatic brain injury. The assay will be studied in a sample population of subjects over the age of 18 participating in college sports.

Concussion or mild traumatic brain injury (mTBI) is a condition that affects hundreds of thousands of patients worldwide. It is a biomechanically induced neurological injury, resulting in an alteration of mental status, such as confusion or amnesia, which may or may not involve a loss of consciousness. Concussion affects about 1.6 million to 3.8 million athletes yearly, most commonly in contact sports such as American football and boxing. Early clinical effects of concussion include but are not limited to behavioral changes, impairments of memory and attention, headache, unsteadiness, and rarely, catastrophic severe brain injury (sometimes described as second impact syndrome). More recently, the consequences of repetitive mTBI from multiple concussions in a sports setting are becoming evident. Repeated concussions have been associated with greater severity of symptoms, with longer recovery time, and chronically with earlier onset of age-related memory disturbances and dementia. As a result and in contradistinction to the decades-earlier perception that these injuries were benign, sports medicine professionals are now increasingly being instructed to recognize and manage concussions as soon as they occur. "Understanding the neurobiology of concussion will lead to development and validation of physiological biomarkers of this common injury." These biomarkers (e.g., laboratory tests, imaging, electrophysiology) will then allow for improved detection, better functional assessment and evidence-based return to play recommendations.

Eligibility Criteria:
Inclusion Criteria:

* The subject is a University of Florida student athlete on a team participating in the study
* The Subject is at least 18 years of age at screening (has had their 18th birthday)
* The Subject is willing to undergo the Informed Consent process prior to enrollment into this study.
* It is the Principal Investigator's opinion that based on the knowledge of the Subject that the Subject is an appropriate candidate for the study.

Exclusion Criteria:

* Participating in another clinical study that may affect the results of either study.
* Venipuncture not feasible (i.e. skin integrity compromised at the venipuncture sites, blood vessel calcification.
* Not available for the end of season follow-up visit.
* The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients

Rationale: Postantibiotic diarrhoea in critically ill patients is common, often prolonged and currently there is no effective treatment of it.

Aim: To test safety and feasibility of faecal microbial transplantation in critically ill patients with postantibiotic diarhoea.

Design: Prospective, single center, parallel group randomised controlled trial. Subjects: ICU patients (both general and burn ICU) who developed diarhea after a course of antibiotic therapy that is persistent for 24 hours and is not due to other causes. Patients with septic shock or approaching death will be excluded.

Treatment in the intervention group: Faecal bacteriotherapy (FBT) delivered as enema (and repeated once in the subgroup of patients with C. dif. infection) of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors.

Control group: Standard-of-care protocolised treatment of postantibiotic diarhea (which includes vancomycine 250 mg p.o. 6 hourly in the subgroup with C. dif. infection).

Primary outcome: Percentage of patients with treatment failure at day 7 after randomisation, which is defined as treatment either not being delivered or not being effective.

Secondary and exploratory outcomes: Influence of the intervention on colonic microbiome and metabolome, small bowel and colonic permeability, bacterial translocation and systemic inflammation response to procedure.


Eligibility Criteria:
Inclusion Criteria:

* signing of informed consent (see below)
* age \> 18 yrs.
* in-patient in ICU or HDU (incl. burn unit) and expected to stay for \>7 days
* diarrhea following antibiotic treatment defined as 3 or more stools per day or Bristol type 7 stool in the volume \>300 ml/day if stool derivative device is in place, persisting for 24 hours despite enteral feeding formula has been stopped.

Exclusion Criteria:

* death appears imminent or ceilings of care put in place
* presence of new-onset sepsis defined as per 2016 definition
* lactate \>2.0 mM, colon diameter \> 9 cm on plain AXR
* the necessity of ongoing antibiotic treatment for another reasons
* unable to tolerate enema for any reason (e.g. surgery of the GI tract in the past year)
* pregnant and lactating woman
* patients with a history of severe anaphylactic food allergy, any other reason which - as per judgement of the treating clinician - makes faecal transplantation unsafe or not feasible (Note: All screening failures based on this criterion will be reported separately, inc. the reason why it was considered unsafe or not feasible to proceed).
LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry

This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.

This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search. Data will be captured retrospectively. Subjects will have been treated with the investigational device in the past and according to standard of care. Subjects will not be involved in any registry related procedures.

Eligibility Criteria:
Inclusion Criteria:

* Subject has undergone surgical treatment with the LifeSpan.
* Surgical treatment was for bypass or reconstruction of diseased or occluded blood vessels (PVP group) or arteriovenous shunting for blood access (AV group).
* For PVP group: Subject's surgical treatment was at minimum 3 years ago, and maximum 10 years ago, at time of enrollment.
* For AV group: Subject's surgical treatment was at minimum 2 years ago, and maximum 10 years ago, at time of enrollment.

Exclusion Criteria:

* None
ALPPS Versus PVE/PL

Study Title Comparison of two different models of liver growth stimulation in advanced colorectal liver metastatic disease, (LIGRO Trial) enabling liver resection

Methodology Scandinavian Multiple Center Randomized Registry Based Clinical Trial

Study duration The planned duration of study participation for an individual subject from inclusion to follow-up are 3 years

Primary investigator:

Per Sandstrom (Linköping)

Number of subjects 100 patients randomized in a 1:1 randomization

Diagnosis and main inclusion criteria Patients with colorectal liver metastasis requiring liver resection, but are not resectable in one step because of a future liver remnant/standardized total liver volume of \< 30 % extrahepatic metastatic disease is not an exclusion criteria if they can be addressed surgically in the future

Overall goal To evaluate if the ALPPS approach is superior to PVE in enabling patients, primarily unresectable due to inadequate FLR, to be resected and reach an R0 situation with an acceptable level of complications and perioperative mortality.

To evaluate if the ALPPS approach increases the growth rate of the liver compared to portal embolization or portal ligation leading to a shorter treatment period.

In addition the investigators aim to study if ALPPS may reach these goals without detectable or improved differences in tumor activity (PFS and OS), but with a shorter recovery and a higher proportion of patients reaching R0.

Hypothesis A higher proportion of patients can be resected with ALPPS counted as rate resected compared to the previously established methods with portal ligation or embolization.

This increased resection rate will not reduce the R0 rate, or increase the rate of Clavien grade 4 complication or higher (H0).

The ALPPS approach will increase the growth rate compared to portal embolization/ligation measured one week after the primary intervention.


Eligibility Criteria:
Inclusion Criteria:

1. By liver tumor board found accepted for inclusion
2. Patients with a tumor burden of colorectal liver metastasis
3. Signed informed content
4. Colorectal liver metastatic disease with an estimated FLR/sTLV of \<30%
5. Primary tumor and any extrahepatic disease possible to resect in patients with liver first approach or after resection of primary tumor.

Exclusion Criteria:

1. Cirrhosis
2. Significant comorbidity rendering subjects unsuitable for major surgery
3. Progressive disease after preoperative oncological treatment
4. Age\<18 years
Type 2 Diabetes Patients Switched From Sulfonylurea With Metformin to Glyburide/Metformin Combination Tablet

To evaluate the efficacy and safety of type 2 diabetes patients switched from sulfonylurea co-administered with metformin to glyburide/metformin combination tablet. It is expected that safety and efficacy of GlucoMet® is not inferior to co-administration of sulfonylurea and metformin.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age between 20 to 75 years and were diagnosed with type-2 DM for a minimum of 4 months before baseline.
* Maintain stable dose of sulfonylurea and metformin co-administered 4 months before baseline.
* Consider suitable to switch from current therapeutic dose to one of the eight testing regimens.
* FPG of 80-200mg/dl at screening visit
* 6.5% ≦ HbA1c ≦ 9% at screening visit, and change of HbA1c ≦ 1% within 12 weeks before screening visit.
* The body index must be between 18.5 and 35 Kg/m2 at screening visit.
* Sign and date the Informed Consent Form

Exclusion Criteria:

* Renal disease or renal dysfunction (e.g. serum creatinine \> 1.5mg/dl)
* Currently significant GI disorder (such as peptic ulcer or diarrhea requiring chronic medical treatment) or which may interfere with absorption of the study drugs.
* History or concurrent liver disease or hepatic impairment (total bilirubin above upper normal limit, ALT or AST above 2.5 times of upper normal limit at screening visit.)
* Acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis, with or without coma.
* History of cardiovascular collapse (shock) or congestive heart failure (function class III to IV).
* History of stroke, myocardial infarction, coronary revascularization, or arrhythmia that requires medical treatment, within past 6 months.
* Having proliferative retinopathy.
* Current acute infection, including systemic infection with fever and/or sepsis, or pulmonary infection, cellulitis, etc.
* Having been treated with insulin during past 6 months, or treated with acarbose or glitazones with change of daily dose past 4 months.
* Seriously dehydrated.
* History of alcoholism (all the time or short-term heavy drinking) or drug abuse, or taking other investigational drug.
* Pregnant or breast feeding women or planning a pregnancy.
* Having a surgery within 4 weeks prior to entering the study or a history of cancer within five years.
* Known hypersensitive to glyburide or metformin hydrochloride.
* Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
Acute Coronary Syndrome in Diabetic Patients

This study aims to compare the clinical profile and outcomes of acute coronary syndrome patients with diabetes and without diabetes.

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under International Classification of Disease (ICD-10) coding of I24.9 were included in this study. The inclusion criteria are patients with primary diagnosis of I24.9 and with a complete record of prior medical and treatment history, electrocardiographic findings, cardiac marker results and outcomes. Participants were grouped into 2 groups - diabetic and non-diabetic based on history of diabetes prior to ACS. Diagnosis of ACS was made based on clinical, electrocardiographic and cardiac marker findings found in the medical record.

Data such as age, sex, ethnic, education, prior medical and treatment history, electrocardiographic and cardiac enzyme results as well as outcomes were collected from the patients' medical records. Outcomes of interest were defined as either concomitant heart failure, acute lung edema, malignant arrhythmia, mortality or combinations of them as diagnosed in the medical records. Heart failure is defined based on echocardiographic findings from the medical records. Acute Lung Edema is defined based on medical records or reported clinical findings of lung edema - rhonchi reported in 1/3 of the lungs with oxygen saturation \<90%. Whereas malignant arrhythmia is defined as the presence of ventricular tachycardia (VT) or ventricular fibrillation (VF).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Acute Coronary Syndrome
* Presence of detail on diabetes history

Exclusion Criteria:

* Unavailability of electrocardiographic findings, cardiac marker results
* Incomplete records of prior medical and treatment history
The Relationship Between Diet and Glycemic Response and Inflammatory Markers in Children With Cystic Fibrosis

The aim of this study is to determine the relationship between diets of children with cystic fibrosis and glycemic responses and some inflammatory markers.

Cystic fibrosis is an autosomal recessive genetic disease; thick, sticky mucus accumulates in the mucin-secreting organs due to the absence or dysfunction of the cystic fibrosis transmembrane regülatör (CFTR) protein. The most commonly affected organ is the lung and the respiratory system disorder is the leading cause of death in patients with cystic fibrosis (CF). Pancreatic insufficiency is also a frequent complication in this patient group in older ages and significantly reduces life expectancy. It is argued that growth and development are adversely affected even in the stages before pancreatic insufficiency occurs. The challenges in the treatment of CFRD include dealing with increased caloric requirements for people with CF, resulting in high carbohydrate intake and frequent snacking, which exacerbates hyperglycemia. This situation causes difficulty in providing glycemic control in patients. In addition, decreased insulin secretion, as well as increased insulin resistance, delay the response to dietary glucose. This leads to an excursion of blood glucose and impaired respiratory function during the day. In addition, increased inflammation exacerbates pancreatic damage. The aim of this study is to determine the relationship between the diets of children with cystic fibrosis and glycemic responses and some inflammatory markers. In this study, general information and anthropometric measurements of patients with cystic fibrosis aged 6-18 will be recorded and their growth and development will be evaluated. With the continuous glucose monitoring system (CGMS) of the participants, the times (at least three, maximum fourteen days) when the blood glucose is below and above the target, the time in the target interval, and glucose fluctuations will be monitored. During the days of monitoring, total energy, macro-micronutrients intakes, glycemic index, and load will be calculated by asking individuals to keep a record of food consumption. The data obtained from the study will be evaluated with the SPSS package program using appropriate statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* A child with cystic fibrosis between the ages of 6 and 18 who had normal glucose tolerance and volunteered to participate in the study will be included in the study.

Exclusion Criteria:

* Children with known chronic diseases such as diabetes, thyroid, liver disease (hepatitis, cirrhosis, etc.), hospitalization and/or surgery at least one month before the start of the study,
* Children who use oral/inhaled steroids, use oral antidiabetic agents, use insulin in the last month,
* Children who have had allergic bronchopulmonary aspergillosis, using intravenous or oral/inhaled antibiotic drugs at least one month ago,
* Children who wear the continuous glucose monitoring sensor for less than three days and do not keep a record of food consumption during the time it is worn
Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation

A randomized controlled study to compare the efficacy of mirabegron, solifenacin and propevirine for treatment of Lower urinary tract symptoms during intravesical BCG installation


Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 years.
* Able to provide an informed consent.
* Denovo or recurrent cases with intermediate and high risk NMIBC eligible for intravesical BCG immunotherapy.
* Persistent LUTS after intravesical BCG induction.

Exclusion Criteria:

* International Prostate symptom score (IPSS) greater than 20.
* Post-void residual (PVR) volume greater than 50 ml.
* Use of medications for overactive bladder.
* Pelvic surgery within the previous 6 months.
* Hypersensitivity for BCG or any of the above mentioned drugs.
* Tumor recurrence during follow up period.
* Other medical conditions that would be adversely affected by anticholinergics such as history of urinary retention due to BPH(Benign prostatic hyperplasia), constipation and history of narrow angle glaucoma.
Vitamin B6 on Relieving Linezolid-associated Cytopenias

Linezolid is the first approved synthetic oxazolidinone that is active against multidrug-resistant Gram-positive pathogens. Because of its significant efficacy, linezolid is widely used in clinical treatment. However, the side effects of linezolid commonly lead to anemia and thrombocytopenia. This hematological toxic effects limit its prolonged used. The investigators have found that Vitamin B6 application, as a preventive, auxiliary therapy, can relieve anemia and thrombocytopenia. The present study was designed to verify the effects of Vitamin B6 in the prevention of linezolid-associated cytopenias and investigate its mechanism.

Infected patients receiving linezolid therapy are divided into two groups, i.e. the linezolid group and the linezolid + vitamin B6 group, the line of division being whether vitamin B6 is to be applied or not in the course of treatment. The purpose is to evaluate the role that vitamin B6 plays, during the process of linezolid therapy, in the relief of erythropenia and cytopenias.

Eligibility Criteria:
Inclusion Criteria:

* Use of linezolid is not less than 3 days

Exclusion Criteria:

* Serious adverse reactions
Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer

This is an open-label, multicenter, randomized phase II trial to evaluate the safety and efficacy of atezolizumab in patients with recurrent cervical cancer in second line therapy. A total of 48 patients will be randomized in 3 arms, each arm consisting of 16 patients:

Arm A: atezolizumab monotherapy q3w Arm B: atezolizumab combined with doxorubicin q3w Arm C: doxorubicin monotherapy q3w


Eligibility Criteria:
Inclusion Criteria:

* Squamous cell or adenocarcinoma of the cervix
* At least one prior chemotherapy regimen for recurrent or advanced disease with a platinum-taxane combination, but not more than two lines of chemotherapy or targeted therapy in recurrent/advanced setting
* Measurable disease
* ECOG≤2
* Adequate pretreatment hematologic, renal and hepatic function test
* Patients are allowed to have had bevacizumab during their prior treatment
* Evidence of non-childbearing status for women of childbearing potential

Exclusion Criteria:

* History of invasive malignancy other than cervical cancer unless there is no recurrence of these other primary tumors the last 3 years.
* Previous anthracycline-based chemotherapy
* Central nerve system metastases and leptomeningeal disease
* Active or history of autoimmune disease
* Prior allogenic bone marrow transplantation or prior solid organ transplantation
* History of idiopathic pulmonary fibrosis
* Known positive test for HIV, or active hepatitis B or hepatitis C
* Known active tuberculosis
* Severe infection within 4 weeks prior to initiation of study treatment
* Prior immunotherapy
The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia

Oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. As known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. The research team is considering that oropharyngeal decontamination with bacteriophages can prevent the developing of the ventilator - associated pneumoniae. There will be three groups in this investigation: placebo, antiseptic drug (Octenisept) and bacteriophage (Sexthaphag).


Eligibility Criteria:
Inclusion Criteria:

- invasive mechanical ventilation beyond 48 hours

Exclusion Criteria:

* hospital - acquired pneumonia
* community - acquired pneumoniae
* BMI \> 35 kg/cm2
* pregnancy
* tracheostomy
* reintubation
Triage Now: an Observational, Prospective Multimarker Study of Biomarkers in Patients Presenting With Chest Pain

Study of diagnostic tests for heart attack for patients with chest pain.

Study of multiple biomarkers, including myeloperoxidase, in the evaluation of patients presenting with suspected acute coronary syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Chest pain and ACS in differential diagnosis
* Age\> 18 years
* Ability to give informed consent

Exclusion Criteria:

* Trauma
* Vulnerable populations
* Known inflammatory condition
Pre-implantation Genetic Testing for Monogenic Disease: Single Center Experience

This monocentric retrospective observational study aims to evaluate the efficacy of pre-implantation genetic testing for monogenic diseases (PGT-M). The effectiveness will be assessed in terms of live birth rate (LBR), cumulative live birth rate (CLBR) per couple, and abortion rate (AR). Considering how many cycles the participants have undergone to achieve a viable blastocyst. The secondary objective is to evaluate the incidence of aneuploidy in unaffected embryos, in order to understand the need for pre-implantation genetic testing for aneuploidy (PGT-A)in addition to PGT-M.


Eligibility Criteria:
Inclusion Criteria:

* Patients fertile or infertile that have undergone preimplantation genetic testing for monogenic diseases (PGTM).

Exclusion Criteria:

* No exclusion criteria will be taken into consideration.