cyrilzakka/clinical-trials huggingface dataset:
Rapid Test to Detect Staphylococcus Aureus in Blood and Wound Infections

The purpose of this study is to determine whether the Cepheid GeneXpert system accurately detects Methicillin-Resistant and -Susceptible Staphylococcus aureus in blood cultures and wound swabs.

Staphylococcus aureus (SA) remains a major pathogen for human beings, causing infections of skin, soft tissue, bone, and other organs. Bacteremia due to this organism is common, and often occurs in association with medical interventions such as intravenous lines and implantable devices. With the increase in methicillin-resistant S. aureus (MRSA), there has been increasing dependence upon vancomycin, a drug that is inferior to the beta-lactams in its activity against methicillin-susceptible S. aureus (MSSA). If the microbiology laboratory had the ability to identify S. aureus (SA) and its drug susceptibility within hours rather than days, focused therapy would be possible earlier in the course of illness. Clinicians would be able to discontinue antibiotics when SA is not present, to discontinue other broad-spectrum antibiotics when SA is present, or to replace empiric vancomycin with nafcillin when MSSA is identified.

The GeneXpert system (Cepheid) uses real-time PCR to detect genes that encode Staphylococcus aureus protein A (SPA), the staphylococcal cassette chromosome (SCC) and methicillin resistance (mecA). All blood cultures with Gram stain revealing Gram positive cocci in clusters will be tested by PCR the day they became positive. Wound swabs submitted for routine bacteriologic culture will be tested within 48 hr of collection. Results will be compared with those of standard bacteriologic culture. In addition, discrepancies between the GeneXpert and wound culture results will be reviewed in the medical record to ascertain whether antibiotic use at the time of specimen collection is associated with false positive results in which the wound culture yields no S. aureus but PCR detects staphylococcal DNA components.

In the second phase of the study, PCR results for wound swabs and blood cultures will be reported to physicians immediately upon completion of the reaction. The clinical impact of early identification of S. aureus will be determined by comparing antibiotic treatment and clinical outcome of patients for whom early identification was available with those of patients for whom conventional bacteriological culture was the sole diagnostic test.

Eligibility Criteria:
Inclusion Criteria:

* Positive blood culture with Gram stain revealing Gram positive cocci in clusters
* All wound swabs submitted to the microbiology lab for standard bacteriologic culture may be included.

Exclusion Criteria:

* Blood cultures that became positive more than 24 hours previously
* Wound swabs for which over 48 hours have passed from the time of collection
Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative

The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.

To observe the PK characteristics of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.


Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal or premenopausal/perimenopausal female patients aged ≥18 years and ≤75 years old.
2. Pathological examination diagnosed as invasive breast cancer with HR+ and HER2-.
3. Underwent radical resection of breast cancer.
4. The score of ECOG was 0 - 1.
5. Fertile women must have a negative serum pregnancy test within 7 days before randomization, and be willing to use acceptable non hormonal contraceptive measures.
6. With my consent and informed consent, I am willing and able to comply with the planned visit, study treatment plan, laboratory examination and other test procedures.

Exclusion Criteria:

1. This Pathological examination diagnosed as HER2-positive breast cancer.
2. The history of any malignant tumor other than breast cancer within 5 years before randomization.
3. At the same time participate in other anti-tumor therapy clinical trials (including endocrine therapy or immunotherapy, etc.).
4. In the 6 months before randomization, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, , etc
5. Inability to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug.
6. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study.
Mixed Reality Technology in Laparoscopic Partial Nephrectomy

The aim of our study was: a) to evaluate the usefulness of the MR model for renal pedicle exposure and identification of the tumor's exact location during LPN, and b) to evaluate the subjective utility of the MR model as an intraoperative reference tool.

Investigators prospectively enrolled 47 patients with LPN between June 2020 and February 2021. Patients were randomly assigned into two groups: the control group (24 patients), who underwent operation with an intraoperative ultrasound (US) control and the experimental group (23 patients), who underwent operation with the aid of the MR model. Randomization was performed using a computerized randomization program and sealed envelopes. Patients were included in the study if they were 18 years of age or older, were able to sign informed consent, and had T1a renal tumors amenable to LPN. Patients were excluded if they were unwilling to participate or did not meet the inclusion criteria. For each patient, investigators prospectively collected demographic data including age, body mass index, clinical tumor size, side, location, and complexity score according to the PADUA scoring system; perioperative data (including time for renal pedicle exposure and time for renal tumor detection and duration of ischemia); pathological data; data on postoperative functional outcome and complications, classified according to the Clavien-Dindo system.


Eligibility Criteria:
Inclusion Criteria:

* able to sign informed consent
* had T1a renal tumors amenable to LPN

Exclusion Criteria:

* were unwilling to participate
* did not meet the inclusion criteria
Strategy for Daily Activity Improvement in Patients With Parkinson's Disease

The symptoms and signs of patients with Parkinson's disease (PD) include bradykinesia, rigidity, tremor and poor sensory integration, which result in mobility disability. Present integrated research project tries to investigate the effects of different physical therapy interventions on daily activities in patients with PD. This integrated research project includes 3 subprojects as follows. The title of Subproject 1 is "Three dimensional motion analysis of daily activities with functional insole in Parkinsonian patients". The title of Subproject 2 is "Immediate and long-term effects of novel plantar mechanical device on postural control in standing and gait performance in people with Parkinson's disease". The title of Subproject 3 is "Upper extremity hand function and coordination during functional movement in patients with Parkinson's disease".

This multidisciplinary research project collaborates with Department of Physical Therapy, and Department of Medicine in Tzu Chi University. Furthermore, this integrated study also works with Department of Neurology, Department of Neurosurgery, as well as Department of Rehabilitation in Tzu Chi Hospital to improve the mobility in patients with PD.

This is a three-year integrated project, and the common purposes of this project in each are as follows. In the first year, it is to compare the daily functional difference between the healthy and the Parkinsonian patients. In the second year, it is to examine the immediate and short-term effects of different interventions on daily activities in Parkinsonian patients.The third year is for upper extremity functional assessment.

In the first year, it is to compare the functional difference of biomechanics and motor control between the healthy and the Parkinsonian patients. In the second year, it is to examine the immediate and short-term effects of functional foot insole and the kinetic training on daily activities in Parkinsonian patients. In the third year, it is to examine the hand tremor during drawing, and the coordination during reaching in Parkinsonian patients.

Eligibility Criteria:
Inclusion Criteria:

* Stage II\~IV of Hoehn and Yahr Staging of Parkinson's Disease and normal subjects, whose age between 40\~75.

Exclusion Criteria:

* Brain injury or hemorrhage, including stroke, etc.
Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting

This study includes an interview with men who have selected "watchful waiting" or "active surveillance" for their localized prostate cancer, in lieu of active treatment (such as surgery or radiation). We hope to understand the educational and support needs of men on surveillance so that we can develop a new intervention that will improve quality of life for such men.

Interviews are conducted over the telephone and require approximately 90 minutes to complete. Men interviewed are compensated for their participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* 1) male,
* 2) 18 years or older, with biopsy-proven prostate cancer,
* 3) diagnosed with localized disease within the last 24 months,
* 4) have a telephone at the time of enrollment,
* 5) have an address where they can receive study materials by mail (a street address or post office box),
* 6) able to speak and understand English;
* 7) have selected surveillance, rather than active treatment for his prostate cancer.

Exclusion Criteria:

* 1) female
* 2) no diagnosis of localized prostate cancer
* 3) completed or undergoing active treatment (e.g., surgery, radiotherapy, etc.)
* 4) no phone or US mail address
* 5) unwilling or unable to provide informed consent
* 6) unable to speak and understand English
SHIELD Study: Using Naso-oropharyngeal Antiseptic Decolonization to Reduce COVID-19 Viral Shedding

Essential workers in positions with increased likelihood of exposure to SARS-CoC-2 will be most impacted by the proposed project. Evidence has shown that the SARS-CoV-2 novel coronavirus is easily transmissable through close contact between individuals, especially during aerosol-generating procedures such as intubation of patients. The intervention proposed in this study (nasal and oral decontamination with povidone-iodine and chlorhexidine, respectively) presents an opportunity for a safe, effective, and feasible treatment to decontaminate the primary entry points for SARS-CoV-2. As such, the intervention to be studied in this project may protect healthcare and other essential workers by preventing transmission of SARS-CoV-2 from patients to healthcare workers, as well as the general public to essential worker,. and thus reducing the incidence of COVID-19 in these workers.


Eligibility Criteria:
Inclusion Criteria:

* Participant is a essential worker performing at least some in-person job duties (not 100% remote)
* Participant is willing and able to perform intervention and data collection procedures.
* Participant is able to provide informed consent in English language.

Exclusion Criteria:

* Diagnosis of COVID-19 within 2 months prior to enrollment, or active respiratory illness symptoms at time of enrollment
* Known medical contraindication to chlorhexidine gluconate or povidone-iodine treatment ingredients (such as a known allergy)
* Participant has a known medical and/or surgical reason prohibiting nasal swab sampling.
* Participant is female who is pregnant, or believes she may be pregnant, at time of enrollment.
* Participant is actively taking/using any treatments or interventions as part of any other COVID-19 related investigational trials.
Drug-Drug Intercations and Direct Acting Antiviral Agents Against HCV

Background: Currently used direct-acting antivirals (DAA) share pharmacokinetic pathways with many comedications commonly used in patients with chronic hepatitis C virus (HCV) infection, therefore drug-drug interactions (DDI) might exist. Although extensive (DDI) verification is recommended by most clinical practice guidelines, real-world studies have shown that approximately one-tenth of patients on DAA therapy also take concomitant medication with the potential for significant interactions. Despite the risk of significant DDI when patients are administered DAA and a concomitant medication, to date, there is very little information on whether these interactions translate into changes in the toxicity or efficacy of any involved DAA or comedication in clinical practice. Clarifying this issue is a critical point, as the DDI profile of the currently used DAA is not the same, with SOF/VEL showing a lower risk of significant DDI than GLE/PIB. Thus the objective of this study is to compare the percentage of comedication switch, withdrawal, or dose reduction at treatment initiation and during treatment with GLE/PIB or SOF/VEL.

Methods: The patients will be enrolled from the GEHEP 001/HEPAVIR cohort. "The HEPAVIR-DAA cohort (NCT02057003)", includes HIV/HCV-coinfected patients, and "the GEHEP-MONO cohort (NCT02333292)", that includes HCV mono-infected individuals, are ongoing prospective multicenter cohorts of patients receiving DAA combinations prescribed in clinical practice, outside clinical trials. Main Study End Point will be the frequency of comedication switch, withdrawal or dose reduction at treatment initiation (index date) and during treatment with GLE/PIB or SOF/VEL.


Eligibility Criteria:
Inclusion Criteria:

1. Treatment naive patients who received therapy with GLE/PIB or SOF/VEL between April 1st, 2018, and July 1st, 2023, receiving ≥ 1 comedication or recreational drug.
2. Attended in a hospital with electronic clinical records allowing access to all clinical visits and prescribed medications, both in all hospitals and in primary care institutions of the corresponding Spanish region during the study period.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

1. HCV treatment-experienced patients will be excluded.
2. Patients without any comedication or recreational drug use
3. Those who have attended private health care
Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients

This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients.


Eligibility Criteria:
Inclusion Criteria:

1. Be able to understand and voluntarily sign the written informed consent, which must be signed before the designated research procedure.
2. Age ≥ 18 and ≤ 75, male or female.
3. Local advanced or metastatic non-squamous NSCLC confirmed by histology or cytology according to eighth edition of the TNM classification for lung cancer.
4. EGFR activating mutation confirmed by tumor histology, cytology or hematology.
5. Failed to previous EGFR-TKI treatment.
6. ECOG performance status 0 to1.
7. Life expectancy ≥3 months.
8. At least one measurable lesion according to RECIST v1.1.
9. Adequate organ function.

Exclusion Criteria:

1. Histological or cytological pathology confirmed the presence of small cell carcinoma or squamous cell carcinoma.
2. Have suffered from the second primary active malignant tumor in the past 3 years.
3. There are other driving gene mutations that can obtain effective treatment.
4. Receipt of the following treatments or procedures: immunotherapy, including immunocheckpoint inhibitors, immunocheckpoint agonists, immunocellular therapy, and any other treatment targeting tumor immune mechanism; systematic chemotherapy in the advanced stage (IIIB-IV); anti-angiogenesis drugs, except for small molecule anti-angiogenesis drugs with drug withdrawal more than 4 weeks; extensive radiotherapy within 4 weeks; EGFR-TKIs within 2 weeks.
5. Symptomatic central nervous system metastases.
6. The toxicity of previous anti-tumor therapy has not been alleviated.
7. Uncontrolled massive ascites, pleural effusion or pericardial effusion.
8. Active autoimmune diseases in the past 2 years.
9. History of interstitial lung disease or noninfectious pneumonitis.
10. Suffering from clinically significant cardiovascular or cerebrovascular diseases.
11. History of severe bleeding tendency or coagulation dysfunction.
12. History of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism in the past 3 months.
13. Serious infection in the past 4 weeks.
14. Acute exacerbation of chronic obstructive pulmonary disease or asthma in the past 4 weeks.
15. History of human immunodeficiency virus (HIV) infection.
16. History of severe hypersensitivity reactions to other mAbs.
17. History of organ transplantation.
18. Any other conditions that, in the opinion of the investigator, may increase the risk when receiving the investigational product.
Angelman Syndrome Natural History Study

The goal of this study is to conduct a prospective, longitudinal natural history study of children and adults with Angelman Syndrome using investigator-observed and parent-reported outcome measures to obtain data that will be useful for future clinical trials.

The overall goal is to increase our understanding of the long-term natural history of Angelman syndrome and obtain Angelman-specific norms for outcome measures that can be used in clinical trials, ultimately improving the care of individuals with Angelman syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Molecular diagnosis of Angelman syndrome

Exclusion Criteria:

* Presence of another condition, unrelated to Angelman syndrome, that affects neurodevelopment
An Immunologic Study of Treatment-Naive HIV Patients Starting a Darunavir/Ritonavir- or Efavirenz-Based HAART

The purpose of this study is to study the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (HIV) infection starting a Darunavir/Ritonavir- or Efavirenz-based highly active antiretroviral therapy (HAART) regimen.

This is an ex-vivo study (study which takes place outside the organism and records immune parameters from stored blood and cells of a defined population without any intervention by the researcher) to evaluate the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (HIV) infection starting a Darunavir/Ritonavir (DRV/r)- or Efavirenz (EFV)-based highly active antiretroviral therapy (HAART) regimen. In previously stored plasma blood samples, the role of DRV/r compared with EFV in reducing T-lymphocyte activation, DRV/r compared with EFV in recovering T-lymphocyte immune phenotype in peripheral blood and thymic production, and DRV/r compared with EFV in recovering T-lymphocyte function (functional immunity) will be studied. Blood samples will be analyzed before (baseline) and up to 48 weeks after initiating HAART.

Each patient will receive orally administered (given by mouth) regimens of either Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina or Efavirenz (EFV) + Tenofovir/Emtricitabina.

Eligibility Criteria:
Inclusion Criteria:

* Documented human immunodeficiency (HIV)-1 infection
* At baseline plasma blood sampling, has never received antiretroviral therapy
* Attending the Clinic of Infectious Diseases of the University of Milan at San Paolo Hospital
* Asymptomatic (demonstrating no acquired immunodeficiency syndrome \[AIDS\]-defining symptoms) at Baseline, Week 12, and Week 24
* CD4 cell count \>50 to \<250/mm3 at Baseline
* Receiving treatment with either Darunavir/Ritonavir + Tenofovir/Emtricitabina or Efavirenz + Tenofovir/Emtricitabina highly active antiretroviral therapy (HAART) regimens at Week 12, Week 24, and Week 48 plasma blood sampling.

Exclusion Criteria is not defined in protocol.
Distribution of Ventilation, Respiratory Drive and Gas Exchange: Measurements and Monitoring

Respiratory physiology involves a complex interplay of elements including control of breathing, respiratory drive, pulmonary mechanics, distribution of ventilation and gas exchange. Body position may also play an important role in respiratory mechanics. While effective methods exist for measuring these variables, they are typically measured in isolation rather than in combination. In pulmonary disease, decreasing mechanical stress and strain and optimizing transpulmonary pressure or the distending pressure across the lung, minimizing overdistention and collapse are central to clinical management. Obesity has a significant impact on pulmonary mechanics and is a risk factor for obstructive sleep apnea (OSA). However, our understanding of these elements is limited even in the general population. The investigators plan to use various validated methods to assess control of breathing, respiratory drive, distribution of ventilation and gas exchange to obtain a better understanding of underlying physiologic signatures in patients with and without obesity and the role of posture/position, with a secondary analysis comparing participants with and without obstructive sleep apnea.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Non-smokers

Exclusion Criteria:

* \<18 years old
* Significant history of pulmonary disease
* Chest wall, anatomical, physical abnormalities, skin integrity issues precluding placement of electrode belt in direct contact with skin
* Skin integrity issues precluding placement of nose clips, or transcutaneous carbon dioxide monitoring
* Inability to form a seal around a mouthpiece
* Known esophageal strictures, webs, or varices (if esophageal manometry to be included)
* Known platelet count \< 100,000 (if esophageal manometry to be included)
* On therapeutic anticoagulation (if esophageal manometry to be included)
* Known multidrug resistant (MDR) pulmonary infection
* Non-English language speakers
* Chronic hypoxemic respiratory failure
* Confirmed or suspected intracranial bleed, stroke, edema
* Active implants (i.e. implantable electronic devices such as pacemakers, cardioverter defibrillators or neurostimulators) or if device compatibility is in doubt
* Pregnant or lactating patients as safety and efficacy for use of EIT in such cases has not been verified