cyrilzakka/clinical-trials huggingface dataset:
Ceftobiprole in the Treatment of Hospitalized Patients With Staphylococcus Aureus Bacteremia

The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.

Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus aureus) activity. Ceftobiprole medocaril in not approved for the treatment of bacterial blood stream infections. S. aureus is a major human pathogen. It causes a wide range of serious infections, including skin and skin structure infections, infections of vascular devices and catheters, and infections of the heart and lungs, bones and joints, and deep tissues. Particularly challenging and difficult to treat are blood-borne infections (bacteremia). Bacteremic infections are prone to relapse and they are often complicated by metastatic seeding of sites throughout the body. MRSA strains are increasing in prevalence, incidence, and virulence. Moreover, the frequency of patients presenting with persistent MRSA bacteremia appears to be rising. The objective of the open label trial is to compare the effectiveness and safety of ceftobiprole versus a comparator in patients with MRSA and MSSA (methicillin-susceptible Staphylococcus aureus) in bacteremic patients. Patients who meet inclusion and exclusion criteria and consent to participate in the study will be randomly assigned to either ceftobiprole or comparator. The primary end point is time to bloodstream clearance of MRSA and MSSA in patients. Patients will be randomized to either ceftobiprole or comparator for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with signs and symptoms suggestive of systemic staphylococcal infection as defined in the protocol
* Female patients must be postmenopausal (for at least 1 year), surgically sterile or practicing an effective method of birth control, male partner sterilization or, at the discretion of the investigator, abstinence, before entry and throughout the study and have a negative urine pregnancy test (confirmed with a negative serum pregnancy test) at screening.

Exclusion Criteria:

* Female patients who are pregnant or lactating
* Known or suspected hypersensitivity to beta-lactam antibiotics or any other study medications
* Receipt of vancomycin or other antistaphylococcal drug for \> 2 calendar days prior to initiation of study drug
* Diagnosis of a catheter-related GPC-cl bacteremia at the time of study enrollment
* Clinical findings of left-sided endocarditis prior to enrollment or any time during study participation
* Requirement for surgery during the seven days of study therapy administration with the exception of surgery required to manage a complication of S. aureus bacteremia
Different Doses of Anti-thymocyte Globin to Treat Child Severe Aplastic Anemia

Severe acquired aplastic anaemia (SAA) is a life-threatening disease characterized by pancytopenia and hypoplastic bone marrow. Immunosuppressive treatment with antithymocyte globulin (ATG)and cyclosporine remain the standard regimen with response rates of 70% or more and excellent overall survival. However ,there are no clinical trials to illustrate the response and complete remission rate with different doses of ATG.And there are no data reported on children with SAA so far.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of childhood acquired severe aplastic anemia(SAA)

Exclusion Criteria:

* clinical diagnosis of no childhood acquired severe aplastic anemia(SAA)
Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy

Recently, MD Anderson Cancer Center reported the phase II trial to investigate high-dose radiotherapy (HDRT, 20-70 Gy) and low-dose radiotherapy (LDRT, 1-10 Gy) for metastatic cancer patients who had undergone immunotherapy. HDRT or HDRT+LDRT was conducted in two respective groups and the treatment group was determined according to the disease status of participants, not randomization. Immunotherapy was maintained in this clinical study. Therefore, we aim to investigate this abscopal effect from adding LDRT to HDRT, irrespective of previous immunotherapy, in this multicenter, single-arm study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who can provide their written informed consent
* Age ≥19 years
* Patients with histologically confirmed primary solid (irrespective of the status of the primary tumor)
* Patients with ECOG performance status 0-2
* Patients planning stereotactic body radiotherapy (three fractions) for extracranial metastases
* Based on RECIST v1.1, patients with at least one extracranial measurable lesion other than SBRT lesions
* Patients with one or more measurable lesions, which are not suitable for SBRT or palliative radiotherapy and can be considered for LDRT (bone metastasis is not indicated for LDRT)
* Patients with hematologic function suitable for radiotherapy (absolute neutrophil count ≥1,500/mm\^3, hemoglobin ≥9 g/dL, platelet count ≥100,000/mm\^3)
* Patients with a life expectancy of 6 months or more according to the researcher's judgment

Exclusion Criteria:

* Patients participating in other clinical studies that may affect the efficacy/safety of this clinical study
* Patients with brain metastasis
* Patients planning SBRT for all measurable lesions due to oligometastasis
* Patients with a history of radiotherapy for extracranial metastases within 3 months of the enrollment
* Patients unable to cooperate with stereotactic body radiotherapy
* Patients who are pregnant or planning to
* Patients with advanced or multiple malignancies requiring aggressive treatment (excluding skin cancers other than melanoma or intraepithelial cancer)
* Patients who have received systemic steroid therapy or immunosuppressive therapy within 2 weeks of enrollment - Patients with an (e.g. allergic disease, radiation pneumonitis, etc.) (The use of steroids for preventive purposes is allowed (e.g., to prevent vomiting during chemotherapy)) active autoimmune disease requiring systemic treatment within the past 2 years, evidence of clinically severe autoimmune disease, or syndrome requiring systemic steroid or immunosuppressive therapy (Patients who need intermittent use of bronchodilators, inhaled steroids, or topical steroid injections, hypothyroid patients on stable hormone replacement therapy, type 1 diabetes patients, or patients recovering from childhood asthma/atopic dermatitis are permitted)
* Patients with active infection requiring systemic treatment
Live Birth Rate in Patients With Unexplained Recurrent Pregnancy Loss

STUDY AIM: to study the pregnancy outcomes and offspring development of patient with Unexplained Recurrent Pregnancy Loss Treated by PGS and spontaneous pregnancy, and to compare the health economic indicators and patient satisfaction of the two modes of pregnancy, so as to better guide the clinical treatment.

400 patients with two times or more unexplained pregnancy loss, who wants to be pregnant via preimplantation genetic screening procedure or spontaneous pregnancy are intended to be enrolled. They are going to divided into two groups: PGS(preimplantation genetic screening) group and SP(spontaneous pregnancy) group. The pregnancy outcomes and offspring development of those patients will be followed up by our investigators.

Eligibility Criteria:
Inclusion Criteria:

* patients with two times or more unexplained pregnancy loss(less than 24 weeks of gestational age, biochemical pregnancy excluded), who wants to be pregnant via preimplantation genetic screening procedure or spontaneous pregnancy.

Exclusion Criteria:

* anatomic abnormality of the reproductive system; endocrine metabolic disease; autoimmune related disease; chromosomal abnormalities; hydrosalpinx; cervical insufficiency.
Total30 for Astigmatism Contact Lenses

Determine if Total30 for Astigmatism contact lenses (CLs) provide a comfortable wearing experience all day. CL discomfort affects most CL wearers with discomfort consistently topping the reasons why established CL wearers drop out of CLs. In fact, studies have consistently found that the frequency of CL dropout is around 20% with this dropout frequency staying relatively stable over the past 20 plus years. This static frequency of CL dropout is surprising since there have been a number of dramatic soft CL innovations during this time frame (e.g., widely available daily disposable CLs, silicone hydrogel CL materials with high oxygen transmissibility, new CL surface coatings).

A common issues that contact lens (CL) wearers frequently face is that their discomfort symptoms increase towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 for Astigmatism CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 for Astigmatism CLs. These data are not only important for judging the performance of Total30 for Astigmatism CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.

Eligibility Criteria:
Inclusion Criteria:

* 18- to 45-year-old
* Visual acuity 20/20 or better
* Contact Lens Dry Eye Questionnaire \[CLDEQ\]-8 scores \<10
* Willing to wear Total30 for Astigmatism CLs
* Have a smart phone with text messaging capabilities
* Astigmatism ranging from 0.75 D to 2.50 D in each eye
* Regularly worn 2 week or monthly CLs within the past 6 months
* Current CL wearer
* Glasses prescription that is less than 2 years old
* Willing to start wearing their CLs between 6:00 AM and 8:00 AM and wear their CLs until 11:00 PM each day text messaging data is collected

Exclusion Criteria:

* Current or past hard CL wearers
* A known systemic health condition that is thought to alter tear film physiology
* A history of viral eye disease
* A history of ocular surgery
* A history of severe ocular trauma
* Have an active ocular infection or inflammation
* Currently using isotretinoin-derivatives or ocular medications
* Currently using rewetting drops or artificial tears
* Pregnant or breast feeding
* Willing to discontinue usage of current toric CLs one week prior to the initial visit
Home Test for Measuring Plasma P-tau217 in Alzheimer's Disease

The goal of this is to develop an easy at home test that can be used to assist in diagnosing Alzheimer's disease (AD). The test will use an FDA approved device for at home blood sample collection. The blood samples will be evaluated to determine if the concentration of p-tau217, a biomarker that is elevated in AD patients, measured from blood samples collected using the at home device is comparable to the results obtained from blood samples collected by venipuncture.


Eligibility Criteria:
Inclusion Criteria:

* Subject with Alzheimer's Disease Only: diagnosed according the NIA-AA diagnostic AD criteria
* Healthy Control Only: Subject does not have history of cognitive impairment
* 55 - 90 years old
* Subject able to comply with study procedures
* Subjects must be able to use the Tasso device for blood sample collection as per the provided instructions (can be performed with the assistance of a caregiver)
* Subjects must be able to undergo IV sampling
* Have a study partner who will provide written informed consent to participate, and assist with blood collection when applicable

Exclusion Criteria:

* Subjects with systemic conditions which were not adequately controlled through a stable medication regimen
* Subjects with any known significant bleeding disorders or conditions that contraindicate blood sample collection (e.g., hemophilia, severe thrombocytopenia)
* Subjects with a known history of severe skin allergies or reactions to adhesives (since the Tasso device involves adhesive application to the skin)
* Subjects currently taking anticoagulant or antiplatelet medications that could interfere with blood collection or increase the risk of complications
* Subjects who have undergone major surgery or have been hospitalized for any reason in the last 3 months prior to study enrollment
* Participation in a clinical study within the 2 month
B40 Non-Invasive Blood Pressure Equivalency Study

The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.

Automated non-invasive blood pressure devices have a long history. These devices first made their appearance in the mid-1970's. Since that time, there have been many improvements in the performance of these devices. Specifically, when making changes to the algorithms that control these devices, the goals are: to improve accuracy and precision in the blood pressure (BP) estimates, to reduce the time needed to determine the BP estimates, to increase comfort for the patient, and to work through artifacts and arrhythmias that are often present in the clinical environment.

The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
* Within the age range from older than 3 years old to 75 years old (adult and child)
* Ability to maintain proper placement of cuff and/or probe and/or sensor

Exclusion Criteria:

* Neonates (ages 0-29 days) and infants (30 days to 3 years old) shall be excluded
* Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
* Known dysrhythmias (when applicable)
* Known disease state that compromises circulation to the extremity
* Vigorous exercise prior to participating in the study
* Excessive movement or excitability causing false values or no determinations
* Known allergy to latex when latex products will be in contact with subject
* Pregnant females
Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma

This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.

This is a single arm, pilot study designed to test the feasibility of using the CIVO (Comparative In Vivo Oncology) system in patients with soft tissue sarcoma accessible for percutaneous injection. Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected 4 to 72 hours prior to surgery using the CIVO device. Minute volumes (up to 8.3 microliters) of saline (negative control) or microdoses of anti-cancer agents will be percutaneously injected in a columnar fashion through each of 8 needles into a single solid tumor. Following the patient's biopsy surgery or tumor resection surgery, the injected portion and a small uninjected portion will be used to determine the in situ drug response in the tumor. None of the data from this evaluation will be shared with patients or used to make clinical decisions. Study clinicians will have access to the patient's health record for 1 year after the study to monitor patient treatment responses. Such information will be used to help evaluate the correlation between clinical response and tumor response assessed via CIVO.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over.
* At least one suspected soft tissue sarcoma tumor that is considered by the investigator to be: (1) accessible for percutaneous injection and (2) at least 2.5 cm in shortest dimension for patients undergoing an incisional biopsy, or at least 3 cm in shortest dimension for patients undergoing an excisional biopsy/tumor resection. Tumors should not be selected if the Investigator believes them to be necrotic or exhibit signs of radiation-induced fibrosis.
* Prior surgical evaluation and plan for surgical biopsy or surgery to remove the tumor being injected.
* ECOG performance status of 0-2 (or a Karnofsky performance status of \>50%)
* Labs required for enrollment (prior to microinjection):

  * Absolute neutrophil count \> 1000/mm3
  * Platelet count \> 50,000/mm3
  * Hematocrit \> 25%
  * Creatinine \<3.0 mg/dl
  * Total Bilirubin \<4.0 mg/dl
  * Bilirubin \<4.0 mg/dl, SGOT ≤ 1.5 times the upper limit of normal
  * PT and PTT ≤ 1.5 times the upper limit of normal

Exclusion Criteria:

* Subjects with active fungal, viral, or bacterial infections.
* Pregnant women.
* Inability to give informed consent.
* Current treatment with anticoagulation such as warfarin or low-molecular-weight heparin.
* Tumors near critical structures such as those located near or in the brain or spine. This assessment will be determined by the treating clinician.
Omega-3/Omega-6 Fatty Acids for Attention-Deficit/Hyperactivity Disorder (ADHD): A Trial in Children and Adolescents

Objective: To assess whether supplementation with Omega 3/6 fatty acids (eye q®) was effective in the treatment of ADHD and its diagnostic subtypes and comorbid conditions, in children and adolescents.

Method: Randomized placebo-controlled one-way crossover trial with 75 children and adolescents aged 8-18 years receiving Omega 3/6 or placebo for three months followed by 3 months with Omega 3/6 for all. ADHD symptoms were measured with the investigator-rated ADHD Rating Scale-IV-Parent Version and the Clinical Global Impression (CGI) scale of symptom severity and impairment.

The study design is a randomised, double-blind placebo-controlled trial with a total duration of 6 months. 50-100 children and adolescents, aged 8-18 years, who meet the DSM-IVÔ criteria for Attention-Deficit/Hyperactivity Disorder (ADHD) of any subtype will be given the opportunity to participate. The study comprises 2 study periods.

Study Period I

This is an assessment/evaluation and drug washout phase of up to 1-3 months for those patients taking any medication excluded by the protocol.

Study Period II

Participants will be randomised to 3 months of treatment with a fixed dose of 6 capsules per day of EyeQ, divided in two daily doses, to supply 558 mg EPA, 174 mg DHA and 60 mg GLA daily, or to placebo. Identical capsules containing olive oil will be used as placebo. Randomisation will be organized by Equazen UK Ltd, who will prepare randomisation numbers to be sent out to the investigation centre. At 3 months a one-way treatment crossover of the placebo-group to active treatment will be made so that both patient groups will receive EyeQ for the remaining 3-month period. Compliance will be ascertained through bi-weekly telephone contacts and at each visit. Compliance is defined as taking the prescribed dosage \>70% of the days in a visit interval.

Neuropsychiatric assessment:

DSM IV checklist ADHD-Rating Scale IV - Parent:Inv Clinical Global Impression (CGI) scale GAF-scale

FTF teacher questionnaire SNAP-IV teacher questionnaire Brown's ADD teacher scale

Neuropsychological assessment:

WISC-III® or WAIS-III® VMI Digit span Span-board task Qb-test

Brown's ADD self report CDI (Children's Depression Inventory)

Five to Fifteen (FTF) parent questionnaire Brown's ADD parent scale SNAP-IV parent questionnaire Nijmegen questionnaire HUFA deficiency questionnaire

Reading and writing tests:

DLS etc

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 8-18 years
* Met DSM-IV criteria for a diagnosis of ADHD of any subtype

Exclusion Criteria:

* Autism
* Psychosis
* Bipolar disorder
* Mental retardation
* Uncontrolled seizure disorder
* Hyper- or hypothyroidism
* Significant other medical conditions
* Weight below 20 kg
* Alcohol or drug abuse or the use in the past three months of any psychoactive drugs or Omega 3 preparations
Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells

Determine the in-vivo mechanism of action of INF-B-1b as it's mechanisms of action are not completely understood. We propose that high dose exogenous recombinant IFN-B-1b induces tolerizing effect on DC-dependent T-cell differentiation in patients with MS by inducing the expression of SOCS3 in DCs.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of MS
* Age 18-60 years, inclusive
* Expanded disability status of 0-6.5
* Give written informed consent prior to any testing under this protocol
Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes

The prevalence of lower extremity arterial disease (LEAD) in patients with diabetes increases significantly and are characterized with obvious arteriosclerosis that are caused by multiple metabolic disorders. Metabolomics measures the metabolites in biological fluids or tissues that generated under certain conditions via rapidly evolving high-throughput technology. Herein, the investigators designed the study to characterize the serum metabolic profiles of LEAD patients and identify metabolic biomarkers using metabolomics. The serum of volunteers, type 2 diabetes mellitus(T2DM) patients with or without LEAD were collected and analyzed using liquid chromatography-mass spectrometry(LC-MS) coupled with a series of multivariate statistical analyses.


Eligibility Criteria:
Inclusion Criteria:

* age ranges from 18 to 100 years old
* Signed informed consent and agreed to participate in this study
* The diagnosis of T2DM is based on standard criteria recommended by WHO since 1999
* The diagnosis of T2DM patient with LEAD is based on standard criteria recommended by Chinese guideline on prevention and management of diabetic foot (2019 edition)(II).

Exclusion Criteria:

* younger than 18 years old or older than 100 years old
* acute infection during the preceding 3 months
* drugs or alcohol addicts
* cancer
* type 1 diabetes
* patients with mental abnormality who are uncooperative with this study
* pregnant or lactating women
* refuse to sign informed consent