cyrilzakka/clinical-trials huggingface dataset:
Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia

RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):

1. Standard culture and antimicrobial susceptibility testing (AST); or
2. Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)

RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):

1. Standard culture and antimicrobial susceptibility testing (AST); or
2. Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)

Patient specimens with positive blood culture with Gram stain showing GNB identified during local laboratory business hours will be enrolled by the Microbiology Laboratory Technologist if they do not meet any exclusion criteria. Subject specimens will be randomized 1:1 to standard culture and AST or Rapid identification and AST using the FDA approved Accelerate Pheno TM System. Both groups will receive standard antimicrobial stewardship (AS). The primary service, including the prescribing provider, will be unaware of group assignment at the time of randomization, so initial antibiotic choice will not be affected by group assignment. Once rapid results become available and/or AS interventions are made, treating providers may become aware of group assignment.

The goal of this study is to determine the impact of rapid bacterial identification and phenotypic antimicrobial susceptibility testing (AST) on antimicrobial usage and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Positive blood culture with Gram stain showing GNB identified during local laboratory business hours.

Exclusion Criteria:

* Identification of GNB outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)
* Positive blood culture for GNB at the same institution within prior 7 days (if known at the time of randomization).
* Deceased at the time of randomization.
* GNB plus gram-positive organism, gram-negative cocci, and/or yeast detected on Gram stain
* Previous enrollment in this study
* No Minnesota research authorization (Rochester site only)
Evaluation of Extended Wear Technology

Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.

A interventional study in which participants will be fit with the commercially available device in one ear and the experimental device in the opposite ear. After two weeks, the devices will be switched so that the participant has worn each device in each ear for a total of 2 weeks. Participants will be blinded as to which device they are wearing in each ear. Comfort and sound quality will be assessed for each device prior to removing from ears.

Eligibility Criteria:
Inclusion Criteria:

* Mild, Moderate and Moderate Severe Hearing loss
* Previous extended wear technology users who rejected or cancelled trials due to discomfort, feedback, migration, or poor sound quality due to fit issues

Exclusion Criteria:

* Participants who can only wear a size XXS (extra-extra small) extended wear device
* asymmetrical hearing loss
* other diagnosis that may cause hearing fluctuation
* inability to tolerate physical fit of Lyric devices
* inability to be seen for four lab visits
Secondary Prophylaxis of CMV Infection Using Letermovir After HID-HSCT

To evaluate the efficacy and safety of secondary prophylaxis of CMV reactivation, clinically significant CMV infection with oral letermovir in Chinese haplo-HSCT patients, as well as treatment-related mortality, all-cause mortality and QoL after transplantation. For enrolled patients, Letermovir would be administered at a dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine). The regimen duration of dosing was approximately 120 days or 16 weeks. Or physicians could adjust regimen duration according to the CMV infection risk factors.


Eligibility Criteria:
Inclusion Criteria:

- (1) Underwent HLA-haploidentical donor HSCT, after at least 1 treated CMV episode since transplant in patients who did not receive primary prophylaxis.

(2) Age elder than or equal to 18 years; (3) Informed consent may be signed by themselves. (4) HIV negative, HBV, HCV negative; (5) Informed consent must be signed before the start of the study procedures, and informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member

Exclusion Criteria:

* (1) received a previous allogeneic HSCT; (2) has evidence of CMV viremia from a central or local laboratory, or CMV end-organ disease within one week prior to enrollment; (3) received within 30 days prior to screening or plans to receive during the study any of the following: cidofovir, or any investigational anti-CMV therapy or biological agent; (4) has severe hepatic insufficiency (defined as Child-Pugh Class C; (5) has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 xthe upper limit of normal (ULN) or serum total bilirubin \> 2.5 x ULN.

  (6) has end-stage renal impairment with a creatinine clearance less than 10 mL/min.

  (7) has both moderate hepatic insufficiency AND moderate renal insufficiency; (8) Uncontrolled infection at enrollment; (9) requires mechanical ventilation or is hemodynamically unstable at the time of enrollment; (10) has documented positive results for human immunodeficiency virus antibody (HIVAb), hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollments; (11) has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas).

  (12) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring; (13) unable or unwilling to sign the consent form; (14) pregnant or lactating women; (15) patients with other special conditions assessed as unqualified by the investigator
Withdraw Drug in Stable IgG4-Related Disease

Evaluation and prediction of relapse risk after glucocorticoid or immunosuppressant withdrawal in patients with stable IgG4 related disease: a prospective cohort study from china.

IgG4-related disease (IgG4-RD) is a chronic autoimmune disease with a relapsing-remitting course. For patients in remission, glucocorticoid (GC) and immunosuppressant are used to be maintained for a long time in fear of disease flare. Long-term GC and immunosuppressant could bring a lot of side-effects and economic burden. Whether and when patients with stable disease should withdraw GC or immunosuppressant? How about the relapse risk respectively? What are the risk factors for disease flare? All the above remain unclear. The aim of this study is to explore the relapse risk after GC or immunosuppressant withdrawal in IgG4-RD patients with stable disease and to establish a predictive model for risk stratification. Meanwhile the investigators aim to testify the effects of immunosuppressant in preventing IgG4-RD relapse. This study is a prospective cohort clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. All patients must meet the following diagnostic criteria of IgG4RD (2011): 1)Swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2)Elevated serum IgG4 (\>1.35 g/L); 3)Histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD. exclusion of other diseases.
2. Disease stabilized more than one year (Responder Index \< 2 points)
3. Dose of Glucocorticoid(GC): prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months
4. Immunosuppressant: one of the following drugs, the same dose maintain at least 3 months (Mycophenolate mate \<= 1g/d or Leflunomide \<=20mg/d or Methotrexate \<=12.5mg/w or Azathioprine \<=100mg/d).

Exclusion Criteria:

1. Patient was diagnosed other connective tissue diseases
2. Patient with tumor
3. Women during pregnancy or planning pregnancy
4. Patient with active infections, including HIV, HCV, HBV, TB, etc.
5. Patient with severe irreversible organ damage
6. Active IgG4-RD, responder index \>= 2 points
7. Stable condition less than one year.
8. Patient with two or more immunosuppressive agents.
9. Biological agents (such as CD20 monoclonal antibody and TNF-a inhibitor) have been used for half a year before admission.
10. Patient with IgG4-RD recurrence during hormone reduction in the past.
Longitudinal Study: Diagnosis and Prediction of Pre-Eclampsia by Using Congo Red Dot Test in Bangladesh and Mexico

A population-based prospective cohort design will evaluate the progression of urine congophilia in pregnancy using the Congo Red Dot test by following patients longitudinally across gestation in Bangladesh and Mexico City.

A population-based prospective cohort design will evaluate the progression of urine congophilia in pregnancy using the Congo Red Dot test by following patients longitudinally across gestation in Bangladesh and Mexico City. A total of 2000 women presenting for prenatal care will be enrolled (1000 at each site). In Bangladesh, pregnant women will be identified during monthly home visits of Community Health Workers (CHW) affiliated with Matlab in Chandpur and asked to participate. In Mexico, women will be identified at routine antenatal appointments. If the woman agrees to participate, investigators will ask her to consent to donation of urine for testing (Congo Red Dot test and Proteinuria dipstick test) at the time of enrollment, four times during her pregnancy (first trimester 6-12 weeks; second trimester 13-28 weeks; third trimester 29-36 weeks; term 37-41 weeks) and possibly three times postpartum (24 hours after delivery and daily until discharge). As a result, the enrolled patients will be followed longitudinally throughout pregnancy until delivery of the baby either at term for an uncomplicated gestation or preterm/term for preeclampsia. The group of women who develop preeclampsia will represent the study group. At the end of the study, the results will be analyzed to identify how many weeks in advance the women who developed preeclampsia displayed congophilia.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Willing to give urine samples at prenatal visits
* Eligible to consent to research

Exclusion Criteria:

- None
Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients

Investigation of effect of perioperative Dexmedetomedine administration on mortality, length of ICU and hospital stay, delirium onset, major adverse cardiac and cerebrovascular events, acute kidney injury in cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Written informed agreement
* Elective surgery
* Use of CPB

Exclusion Criteria:

* Previous prolonged immobilization
* Reoperation
A Study of LY2940094 in Participants With Alcohol Dependency

The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce alcohol drinking in these participants. The study will last for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Present with alcohol dependence (AD) defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR 303.9)
* Must have 3 to 6 heavy drinking days per week as assessed by the Timeline Follow Back (TLFB) scale at screening and baseline (heavy drinking is defined as greater than 4 drinks per day for females and greater than 5 drinks per day for males)
* Have a body mass index (BMI) between 18 and 35 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* Have had prior seizures or other condition that would place the participant at increased risk of seizures, and participants taking anticonvulsants for seizure control
* Have any other clinically significant medical condition or circumstance prior to randomization that, in the opinion of the investigator, could affect participant safety
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM-IV) Axis I criteria for a lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar I disorder, or other psychoses
3D Ultrasound Breast Imaging

The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.


Eligibility Criteria:
Inclusion Criteria:

* Adult women ≥ 18 years of age.
* solid breast lesion and ultrasound guided biopsy (either as part of their clinical care or through participation in other IRB-approved studies)
* lesion size of 3mm or larger

Exclusion Criteria:

* \< 18 years of age.
* Lacking capacity to consent
* Pregnant or lactating
* Receiving cancer therapy such as chemotherapy or radiation therapy
Balloon-Assisted Enteroscopic Treatment for Phytobezoar

By reviewing a case series of patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital, we analyzed the safety and efficacy of this technique.


Eligibility Criteria:
Inclusion Criteria:

* Retrospectively collect data from patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital.

Exclusion Criteria:

* Patients with incomplete clinical data.
Needs Assessment and Quality of Life of Stroke Patients and Their Caregivers

The incidence of Stroke in France is about 150 000 per year. Stroke represents the leading cause of long-term disability. The specificity of stroke is the sequelae polymorphism that can occurs: physical disability, cognitive deficit and sensitive trouble. Then this large extend of sequelae may have a different impact on daily life. Therefore, we have to consider the individual's own resources and in his whole environment to face the situation. We suppose that each situation, each post-stroke disability will have a different social impact in stroke survivors and their caregivers. Nowadays, Barthel Index and Rankin scale are the standards for the assessment of the stroke impact on survivors' daily life. However, what is the real impact of an activity limitation in daily life? How consider the psychosocial impact of stroke only with functional indicators? For this study we will consider handicap and disability in a societal way. In fact, the WHO developed in 2001 the International Classification of functioning, disability and health that allows to bring the concept of participation restriction, this is to say the consequences of a disability in the real life. The ICF allows to bring a conceptual framework of participation restriction.

Psychosocial consequences of stroke are relatively unknown especially in France. According to our hypothesis, patients with major disabilities and their caregivers will experience more psychosocial consequences and participation restriction in terms of emotional health, quality of life and burden. Also, we hypothesize that stroke severity, the typology of disabilities (motor, cognitive and sensorial) will have a different impact on patients and proxys' lifes in terms of psychosocial consequences, participation restriction and quality of life.

TYBRA study is a prospective multicentric cohort study that mixes qualitative and quantitative approaches. The first aim of the quantitative approach is to explore factors related to patients and their caregivers at 6 months that predict participation restriction at 12 months post-stroke. The first aim of the qualitative study is to explore the experience of stroke in minor stroke patients and their proxys.


Eligibility Criteria:
Inclusion Criteria:

* Quantitative study : (patients included in Stroke 69 cohort study)

  * Diagnosis of stroke confirmed by a neurologist or by an emergency doctor after brain imaging (CT or MRI scan)
  * Patients admitted to an emergency department or a neurovascular unit in Rhône department whatever their geographical origin
  * Concerning proxys : Caregivers of patients included in Stroke 69 cohort study and eligible to TYBRA study.

Qualitative study : (patients included in Stroke 69 cohort study)

* Patients included in Stroke 69 cohort study with a diagnosis of stroke confirmed by brain imaging
* Minor stroke (Rankin \<1)
* Proxys of minor stroke patients

Exclusion Criteria:

* Patients institutionalized before stroke and/or at 6 months and/or at 12 months
* Patients who have major cognitive trouble
* Stroke during hospitalisation
Cervical I/F Cage for Anterior Cervical Fusion

The purpose of this study is to determine the clinical success of the Cervical I/F Cage in treatment of one or two adjacent levels of degenerative disc disease of the cervical spine compared with standard of care treatment using either autograft, autograft with a plate or allograft with a plate

This is a prospective randomized multi-center clinical trial to assess the safety and efficacy of the investigational device, Cervical I/F Cage for fusion in one or two adjacent levels of the cervical spine. Patients will be randomly assigned in a ration of 1:1 between the investigational and control groups.

Comparison: The device will be compared to a control group consisting of the 3 accepted standard of care treatments (autograft, autograft with an anterior plate, or allograft with an anterior plate). For two level fusions, the control group will be limited to autograft with a plate or allograft with a plate. Based on the current literature, it is believed that there is no difference between the three treatments in terms of clinical success, fusion success, or safety issues. However, amongst the investigators there are preferred treatments. Each investigator will choose one or more of the control treatments at study initiation. Patients will then be randomized in a 1:1 Cage:control randomization schema. Approximately 240 subjects will be enrolled at 20 sites. Eligible patients will have symptomatic degeneration of one or two adjacent cervical discs, have failed six weeks of non-surgical treatment, have sufficiently severe enough symptoms to warrant surgery, and have had no prior fusion surgery on the cervical spine.

Eligibility Criteria:
Inclusion Criteria:

* Persistent recurrent neck and/or shoulder and arm pain refractory to 6 weeks of non-surgical therapy.
* Radiographic evidence of significant disc degeneration at one or two adjacent cervical levels (C4-7)

Exclusion Criteria:

* Significant degeneration at more than two cervical levels,
* Prior surgical treatment of the cervical spine; laminotomy or foraminotomy allowed,
* Gross instability due to trauma,
* Disability in the lumbar spine,
* Infection in the disc or spine, past or present,
* Any active infection at time of surgery,
* Tumor in the spine,
* Significant osteoporosis or metabolic bone disease,
* Pregnant, lactating or wishes to become pregnant within duration of the study,
* Refusal to accept the use of autograft tissue.
A Retrospective Analysis to Evaluate Long Term Outcomes of SCC Patients Previously Treated With Alpha DaRT

Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response.

Medical records of patients that previously underwent the Alpha DaRT treatment will be reviewed by an authorized staff member.

Evaluation of long-term outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response. These outcomes include:

* Safety - assessment of late onset of Alpha DaRT related AE in patients treated with the Alpha DaRT seeds
* Efficacy -

  * assessment of local recurrence rates in patients who achieved initial complete response (CR) following the Alpha DaRT treatment
  * assessment of duration of response in patients who achieved initial CR following the Alpha DaRT treatment
  * assessment of survival status in patients treated with the Alpha DaRT seeds

Eligibility Criteria:
Inclusion Criteria:

* Patients previously treated with the Alpha DaRT seeds for management of either skin or oral cavity SCC
* Available information in medical charts and records (electronic or paper)

Exclusion Criteria:

None.
Nocturnal Breathing and Sleep in Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude

The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate altitude.

This randomized cross-over trial evaluates the hypothesis that patients with chronic obstructive pulmonary disease experience nocturnal hypoxemia, periodic breathing and sleep disturbances when staying at moderate altitude. Sleep studies and clinical evaluations will be performed during 2 days in Zurich (490 m, low altitude baseline) and during 2 days at Davos Clavadel (1650 m), and 2 days at Davos Jakobshorn (2590 m).

Eligibility Criteria:
Inclusion Criteria:

* chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
* residents at low altitude (\<800 m)

Exclusion Criteria:

* Unstable condition, COPD exacerbation
* Mild (GOLD 1) or very severe COPD (GOLD 4)
* requirement for oxygen therapy at low altitude residence
* hypoventilation
* pulmonary hypertension
* more than mild or unstable cardiovascular disease
* use of drugs that affect respiratory center drive
* internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day), inability to perform 6 min walk test.
* previous intolerance to moderate altitude (\<2600m).
* Exposure to altitudes \>1500m for \>2 days within the last 4 weeks before the study.
* Pregnant or nursing patients
Correction of Selenium Deficiency Has Effect on Thyroid Function

Previous literature has found potential association between selenium deficiency and inactivated glutathione peroxidase and deiodinase, which may contribute to subsequent elevation of T4 and ratio of T4/T3. Conduction of a case-control study (ID: Liuyanping3) has been applied on Clinicaltrials.gov to further elucidate effect of selenium deficiency on thyroid function. Based on its data, the investigators will perform a randomized, placebo-controlled,single-blinded crossover study on 20 participants with selenium deficiency to verify health consequence of selenium.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of selenium deficiency through serum selenium test in previous phase (ID: Liuyanping3) of the study
* Should have stable body weight in the latest 3 months;
* Should be not prescribed with thyroid hormone replacement therapy
* Should be without medical history of thyroid surgery or iodine radiotherapy
* Should have normal FT3, FT4 and TSH.

Exclusion Criteria:

* Clinical diagnosis of acute critical illness in the latest 1 year
* Have had weight fluctuation by more than 5%
* Eating disorders
* Neuropsychological disorders
* Allergy to corn or yeast