cyrilzakka/clinical-trials huggingface dataset:
Mucormycosis Clinical Core for the MUCOR-ADVANCE P01 Project

To collect data and samples from participants with cancer who also have invasive mucormycosis, invasive aspergillosis, bacterial pneumonia, or a risk for fungal infection.

Primary Objective:

To establish MD Anderson Mucormycosis Clinical Core for the MUCOR-ADVANCE P01 Project.

* To prospectively identify, collect, and store all isolates causing proven or probable MCM in adult high-risk cancer participants.
* To prospectively identify, collect, and store relevant host samples from high-risk participants developing proven or probable MCM, along with relevant biospecimens from three control groups.
* To comprehensively annotate clinical specimens and provide information regarding the course and outcome of all MCM cases and controls.

OUTLINE:

This is an observational study. Patients are assigned to 1 of 4 groups.

GROUP M: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

GROUP A: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

GROUP B: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

GROUP C: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18-100 years old and have cancer and invasive mucormycosis, invasive aspergillosis, bacterial pneumonia, or a risk for fungal infection but no evidence of such infection.
* Patients must be willing to undergo routine diagnostic procedures (e.g., phlebotomy, bronchoscopy, biopsy) as part of their regular care.

Exclusion Criteria:

• Patients who are unwilling to undergo routine diagnostic procedures as part of their regular care.
Namsos Anaesthesia Children Outcome Study

Behavioral disturbances are often seen in children after anesthesia both immediately after surgery (emergence delirium) and after discharge from hospital. Persisting behavioral changes may affect emotional and cognitive development. It is known that both type of surgery and anesthetic management affect the occurrence of behavioral disturbances. Specifically, differences in occurrence were found after sevoflurane anesthesia and propofol anesthesia, two anesthetics that are generally used in practice. However, evidence is based on methodologically weak studies.

The described occurrence of behavioral disturbances in children after anesthesia is not in line with the investigators' clinical experience, and neither are the described differences in occurrence between sevoflurane anesthesia and propofol anesthesia. This study will compare emergence delirium and behavioral changes after discharge from hospital in children who had surgery for removal of their tonsils under sevoflurane anesthesia versus propofol anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* adenotomy and/or tonsillotomy and/or tonsillectomy
* ASA physical status class I or II

Exclusion Criteria:

* unexperienced ear-nose-throat (ENT) surgeon (ENT surgeon \< 1 year of training, ENT surgeon without experience with the use of laryngeal mask as airway during adenotomy/tonsillotomy/tonsillectomy)
* preoperative syndromes
* ASA physical status class \> 2
* missing written consent from parents/guardians
Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
* The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
* The subject, based on his/her knowledge, must be in good general health.
* The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
* Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
* Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
* Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.
* The subject must read, indicate understanding of and sign the Informed Consent Form.

Exclusion Criteria:

* The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
* The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
* The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)
* Slit lamp findings that would contraindicate contact lens wear such as:

  * pathological dry eye or associated findings
  * pterygium or corneal scars within the visual axis
  * neovascularization equal to or greater than 1mm in from the limbus
  * history of giant papillary conjunctivitis (GPC) worse than grade 2
  * anterior uveitis or iritis (past or present)
  * seborrhoeic eczema
  * seborrhoeic conjunctivitis
* A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
* A known history of corneal hypoesthesia (reduced corneal sensitivity).
* Contact lens snellen visual acuities (VA) worse than 20/30.
* Aphakia, keratoconus or a highly irregular cornea.
* Current pregnancy or lactation (to the best of the subject's knowledge)
* Any active participation in another clinical study at any time during this study.
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis

The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18 to 80 years of age;
* diagnosis of myasthenia gravis;
* history of myasthenia weakness involving more than ocular (ie eye) or peri-ocular muscle;
* duration of myasthenia gravis symptoms (including ocular symptoms) \<=10 years;
* prednisone dose \>=20 mg/day (or equivalent alternate-day dose) for \>=4 weeks.

Exclusion Criteria:

* female patients who are pregnant, breastfeeding, or lactating;
* regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 2 weeks prior to randomization;
* any prior clinically significant use of CellCept or other immunosuppressive therapy (except corticosteroids), or within 8 weeks prior to randomization.
The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo

A national, prospective single arm phase II study investigating the pharmacokinetics and safety of the 2% TD1414 cream when applied 3 times daily for 7 days to adult patients with impetigo or Secondarily Infected Traumatic Lesions (SITL). A total of 20 patients will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to comply with all the study requirements/procedures
* Age ≥ 18 and ≤65 years
* Primary bullous/non-bullous impetigo or SITL
* Patients suffering from primary bullous/non-bullous impetigo must have:

  * Not more than 10 discrete lesions, and
  * A total lesional area ≥ 1 cm2 and ≤ 100 cm2, and
  * Any surrounding erythema must not extend beyond 2 cm from the edge of the lesion, and
  * Total SIRS score equal to or ≥ 8
* Patients suffering from SITL must have:

  * A total infected area of the traumatic lesion ≥ 1 cm2 and ≤ 100 cm2, and
  * Any surrounding erythema must not extend beyond 2 cm from the edge of the lesion, and
  * Total SIRS score ≥ 8, and
  * SITL not caused by burns or animal/human bite
* Amenable for treatment with topical antibiotic alone
* Body Mass Index ≥18 and ≤ 35 kg/m2.

Exclusion Criteria:

* Immunosuppressed state or other serious systemic disease
* Signs and/or symptoms of systemic infection, such as malaise and fever or local adenopathy and fever
* Unwillingness to abstain from use of any other topical products including emollients on the lesional area during the study
* Systemic treatment with antibacterials or immunosuppressive agents (e.g. corticosteroids) within 2 days before day 1 (inhaled/intranasal steroids may be used)
* Topical treatment with antibacterials, immunosuppressive agents (e.g. corticosteroids) or antiseptics (e.g. alcohol, chlorhexidine, hydrogen peroxide, iodine) on the lesional area within 2 days before day 1
* Indication for surgical or systemic treatment of the SITL/impetigo
* Known or suspected hypersensitivity to any of the components of the study medication
* Participation in any other interventional clinical trial or use of an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to day 1
* Previously enrolled in this study
* A blood alcohol content ≥ 0.08% as determined by a Breathalyzer test
* Known or suspected history of alcohol abuse/alcoholism or drug abuse
* Known or suspected impairment of liver function
* Heart rhythm disturbances or clinically significant quantitative or qualitative abnormality in the pretreatment ECG
* Blood donation in excess of 500mL within 56 days before day 1 or donation during the study or within 3 days of leaving the study.
Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.

Patients are randomized to one of two groups.

GROUP A - Will receive IV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 milliliters (mL) normal saline (NS).

GROUP B - Will have IV cefepime started in pre-op within 1 hour of incision. Intraosseous (IO) administration of vancomycin (500mg in 250 milliliters NS) will be administered in the OR after sterile prep and draping has occurred. Injection will take place into the greater trochanter (within a pre-specified region).

Both Groups will be monitored during surgery and immediately post-operatively for adverse injection reactions (i.e. Red Man Syndrome). Both groups will otherwise follow identical post-operative protocols (including post-operative antibiotic administration).

TISSUE SAMPLES Five (5) tissue samples will be taken from each patient, 2 soft tissue samples and 3 bone samples will be taken throughout the course of the procedure.

One blood sample will be taken in both groups intraoperatively at the time of initiation of closure.

These samples will immediately be sent to a lab for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing a primary total hip arthroplasty
* Patient gives informed consent to participate in the study.
* Age Range \>18

Exclusion Criteria:

* Previous surgery on the hip (including hip scopes)
* BMI above 35
* Contraindication to receiving vancomycin or cefepime (allergy, medical issue, etc)
* Inability to locate the greater trochanter or administer the IO infusion
* Refusal to participate
* Diabetes
* Immunocompromised or immunosuppressed patients (HIV, Hep C, End stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).
Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model

To evaluate an alternative clinical genetics cancer care delivery model, using non-genetic providers to introduce and order genetic testing. 250 prostate and 250 pancreatic patients will be recruiting. They will undergo genetic testing and complete study questionnaires. Results from this pilot study will be used to inform the strategies used by the Clinical Risk Evaluation Program (CREP) Genetic Counelors (CGS) and GI/GU physicians to deliver genetic testing and return genetic risk information to patients with prostate or pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* • Penn patient age 18 years or older.

  * Diagnosed with prostate cancer or pancreas cancer.
  * Deemed to be clinically appropriate for multiplex genetic testing by their Urologic Cancer Program (GU) physician or Gastrointestinal Cancer Program (GI) physician at the Abramson Cancer
  * Agreed to receive clinical multiplex genetic testing from their physician.
  * English-fluent; the surveys were designed and validated in English and are not currently available in other languages.

Exclusion Criteria:

* • Patients who do not or will not receive their ongoing cancer care at Penn

  * Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation.
  * Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula

This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age at birth less than 37 weeks
* Birth weight less than 3200 g (approximately 7 pounds)
* Postmenstrual age is 34 0/7 through 41 0/7 weeks at enrollment
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
* The currently-fed formula is a milk-based infant formula at a caloric density of ≤ 24 Cal/fl oz.
* Singleton, twin, or triplet births only.
* Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
* Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Participant is taking and plans to continue taking medications, home remedies, herbal preparations, prebiotics or probiotics, rehydration solutions, or parenteral nutrition
* Participant is known to require elective surgery with hospitalization, other than uncomplicated outpatient surgery, during the course of the study.
* Participant is in another study that has not been approved as a concomitant study
* Participant has an allergy or intolerance to any ingredient in the study product
* Participant is currently receiving oxygen therapy
* Participant is currently receiving antibiotics
* Participant is currently receiving tube feedings
Tryptophan Depletion in Acute Mania

Serotonin (5-HT) is important in mood regulation and is believed to play a major role in the pathophysiology of major depression (MD). Selective serotonin reuptake inhibitors (SSRIs) are currently the most widely used drugs for the treatment of depression. Patients with bipolar disorder (BD) who are treated for depression with SSRIs might develop mania, which is believed to be triggered by antidepressant treatment. Rapid tryptophan depletion (RTD) has been shown to induce transient depressive symptoms in remitted depressed patients treated with SSRIs. In remitted manic patients treated with lithium, RTD does not seem to have clinical effects. However, RTD was not studied in acutely manic patients and could theoretically have antimanic properties. In this double blind randomized placebo controlled study RTD will be used as a tool to assess the role of 5-HT in mania and will be evaluated for its antimanic properties and potential use as augmentation to drug treatment in acute mania.


Eligibility Criteria:
Inclusion Criteria:

* Acute mania
* Ability to provide written informed consent

Exclusion Criteria:

* Mixed affective states
* Suicidal ideation
* Uncontrolled systemic illness
Study to Evaluate the Efficacy and Safety of Daglutril Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension

This study is to evaluate the end of treatment effect of Daglutril compared to placebo on top of losartan.


Eligibility Criteria:
Inclusion Criteria:

* treated with optimized dose of losartan (constant dose for at least four weeks before randomization and throughout the whole study period) for at least four weeks
* urinary albumin excretion ≥ 20 and \< 1000 µg/min
* sitting systolic/diastolic blood pressure (SBP/DBP) \< 140/90 mmHg at the end of placebo run-in phase

Exclusion Criteria:

* known secondary hypertension
* decompensated congestive heart failure
PET TDM FDG-Choline as a Decision-making Tool for Routine Care on the Liver Transplant List for HCC

HCC is the most common malignant liver tumor for which liver transplantation is one of the pivotal curative treatments. The best possible selection of patients who are candidates for transplantation is essential in the current context of a shortage of transplants. Performing a PET CT scan is not currently recommended in the pre-liver transplant workup for HCC. However, PET CT using in a complementary manner the FDG and Choline tracers appears promising in the management of HCC in view of its wide use in oncology and its major diagnostic and prognostic contribution compared to conventional imaging. In order to address this issue, a prospective cohort study including patients from the University Hospital of Rouen and Lille with hepatocellular carcinoma meeting the criteria for indication of liver transplantation validated in SPC will be set up, the main objective of which will be to assess the decision-making contribution of PET TDM FDG and Choline in addition to conventional imaging in the pre-transplant assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patient candidate for liver transplantation for hepatocellular carcinoma from the University Hospital of Lille and Rouen, whose therapeutic transplantation project has been validated and having an AFP score ≤ 2 (diagnosis of HCC defined on non-invasive imaging criteria according to the recommendations of EASL-EORTC 2012 or confirmed histologically).
* No opposition to participating in the study.
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patient with an AFP score ≥ 3
* Patient contraindicated to PET FDG or Choline.
* Other tumor: Cholangiocarcinoma.
* Diabetes unbalanced HbA1c\> 9%, and fasting hyperglycemia (\> 2g / L) which does not allow the completion of the PET examination.
* Patient under guardianship or curatorship.
* Pregnant or breastfeeding woman.
Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in Elderly People With Chronic Bronchitis and COPD

Evaluation of immunogenicity, safety and persistence of the subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease received the third dose of inactivated COVID-19 vaccine .

The subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease recruited to receive a third dose of inactivated COVID-19 vaccine.

Blood samples will be collected 3 times: before the third dose of vaccinatioin，28 days and 6 months after the third dose of vaccination.

Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 60 and above with full capacity for civil conduct;
* Chronic bronchitis (or chronic obstructive pulmonary disease) diagnosed by a medical institution at level I or above;
* Body temperature \< 37.3 ° C confirmed by clinical examination before enrollment ;
* Able and willing to complete the entire study plan during the study follow-up period;
* Have the ability to understand the study procedures, voluntarily sign informed consent, and comply with the requirements of the clinical study protocol;
* Subjects participating in the past clinical trial have completed two doses of COVID-19 vaccine and blood collection before and after immunization;

Exclusion Criteria:

* Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons;
* Being allergic to any component of vaccines (including excipients) ;
* Injection of non-specific immunoglobulin within 1 month before enrollment;
* Injection of live attenuated vaccines within 1 month and injection of other vaccines within 14 days before enrollment;
* Subjects who have experienced severe allergic reactions to vaccines (e.g. acute anaphylaxis, urticaria, angioneurotic edema, dyspnea, etc.);
* Having uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome;
* Having severe liver and kidney diseases, malignant tumors, acute diseases or acute episodes of chronic diseases;
* Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia or other autoimmune diseases;
* Have been diagnosed with thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection;
* During an acute episode of chronic bronchitis/chronic obstructive pulmonary disease;
* Subjects who had vaccine-related adverse reactions after the second dose;
* Having high fever (axillary temperature ≥39.0℃) for three days after the second dose of inoculation, or severe allergic reaction;
* Having any adverse nervous system reaction after the second dose;
* During the acute onset of a chronic disease, or the recovery of acute complications less than two weeks;
* Other reasons for exclusion considered by the investigator.
Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy

In the diagnosis and treatment of patients with sepsis, through routine stool testing and dynamic testing of coagulation function, we found that patients often have stools that are not formed, the proportion of main fecal bacteria is imbalanced, the level of blood bacterial toxins rises, and the abnormal coagulation status indicate the gut microbiome dysbiosis may play an important regulatory role in abnormal blood coagulation in patients with sepsis. Therefore, we propose that the gut microbiome dysbiosis is involved in sepsis-induced coagulopathy. This project intends to prospectively observe the changes in gut microbiome dysbiosis and blood coagulation function in patients with sepsis before and after treatment, and explore whether the changes in gut microbiome dysbiosis promote the development of sepsis through coagulation disorders, provide new research perspectives for diagnosis and treatment for sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and ≤85 years
* Sign the informed consent form
* Expected ICU hospital stay\> 24 hours
* △SOFA score ≥2 and confirmed or suspected infection

Exclusion Criteria:

* Pregnant or breastfeeding women
* Estimated survival time \<24 hours
* Diagnosis of sepsis time\> 24 hours
* The length of ICU stay before diagnosis of sepsis\> 7 days
* Sepsis from which the source of infection cannot be determined
* Congenital coagulopathy