cyrilzakka/clinical-trials huggingface dataset:
Decreasing Unnecessary Antibiotics Prescribed for Possible Pneumonia Despite Normal Respiratory Rate and Oxygenation

The purpose of this study is to decrease unnecessary antibiotics prescribed to hospitalized patients for possible pneumonia by flagging patients with respiratory rates and oxygenation levels within reference ranges given prior data suggesting that discontinuing antibiotics in this population is safe. Patients will be randomized to 3 arms: 1) usual care, 2) electronic alert, or 3) pharmacist outreach.

Prior data suggest antibiotic starts for patients with normal vital signs are common and there does not appear to be harm associated with stopping antibiotics after only 1 or 2 days in patients with normal oxygen saturations. We therefore propose a pilot patient-level three-way randomized trial to determine the best way to operationalize professional society recommendations for post-prescription antibiotic reviews amongst patients started on antibiotics with a stated indication of pneumonia despite normal respiratory rates and oxygenation levels. If the patient's median respiratory rate and oxygen saturation is normal after 1-2 days of antibiotics they will be randomized to usual care versus a EHR-based best practice alert versus pharmacist outreach. The EHR-based best practice alert will highlight the patient's normal respiratory rate and oxygenation and encourage stopping antibiotics if there isn't another indication for antibiotics. Pharmacist outreach will involve contacting the responding clinician or attending physician to determine the working diagnosis, review the patient's vital signs, and to ask the team to consider stopping antibiotics if there are no clear indications for antibiotics. In all cases, the final decision on whether to stop or continue antibiotics will be up to the primary team. We will assess the impact of these post-prescription review strategies to decrease unnecessary antibiotic utilization on antibiotic utilization (antibiotic days and antibiotic-free days) compared to usual care. Safety outcomes will include time to discharge, readmissions, hospital-free days, and mortality. We will also assess for change in the primary outcome over time.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to Brigham and Women's and BWH Faulkner Hospitals and prescribed antibiotics with a stated indication of pneumonia who have a median respiratory rate of ≤20 and oxygen saturation of ≥95% without supplemental oxygen sustained for at least 24 hours.

Exclusion Criteria:

* Patients under 18 years old, patients on transplant and oncology services, patients who are pregnant, patients in an intensive care unit, patients with cystic fibrosis or bronchiectasis, patients on immunosuppressive medications, and patients with positive blood cultures (other than common skin contaminants)
Cross-section Survey of Mechanical Ventilation and Acute Respiratory Distress Syndrome in China

The characteristics and outcomes of a mixed group of critically ill patients who received mechanical ventilation are not known in China.

A 1 month Cross-section survey will be performed with the aim of describing the characteristics and outcomes of conventional mechanical ventilation and treatment of acute respiratory distress syndrome in intensive care units in China.

From August 31th 2012 to September 30th 2012, all patients admit to ICUs were screened, mechanical patients and patients with ARDS be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality, and the treatment of ARDS will be recorded.

Eligibility Criteria:
Inclusion Criteria for mechanical ventillation patients:

Meet one of the following criteria

1. Patients who were admitted to ICU from September 1st to 31th 2012, and received invasive mechanical ventilation for more than 24 hours
2. Patients who were admitted to ICU from September 1st to 31th 2012, and received non-invasive mechanical ventilation for more than 12 hours
3. Patients who were admitted to ICU from September 1st to 31th 2012, and who fulifll the ARDS Berlin Definition or AECC Definiton

Exclusion Criteria:

1. lesson than 18 years old or more than 85 years old
A Study on Immunity Duration Against Polio Over 18 Months Infants After 2 or 3 Primary Doses Sabin IPV in China

In 2017, China CDC conducted a study titled "A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China". At present, all the infants in the monitoring cohort were over 18 months old and at least one year had elapsed since the last dose of sIPV inoculation.Since there is no any data about the protection duration of two-dose Sabin IPV schedules, China CDC propose to follow up the study cohort to evaluate the proportion of seroprotection of antibody and measure neutralizing antibody titers against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in Chinese children.

In 2017, China CDC conducted a study titled "A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China". This study offers evidence that two doses of sIPV administered at 4 and 8-11 months of age and three doses of sIPV administered at 2, 3, and 4 months of age both provide serological protection against poliomyelitis. At present, all the infants in the monitoring cohort were over 18 months old and at least one year had elapsed since the last dose of sIPV inoculation.

Since there is no any data about the protection duration of two-dose Sabin IPV schedules, China CDC propose to follow up the study cohort when all subjects are at least 18 months old to monitor persistence of antibody. So that, if the antibody levels are not high enough to protect children from the disease, remedial measures can be taken as soon as possible.So China CDC conduct this follow up study ,to

1. Evaluate the proportion of seroprotection of antibody against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in Chinese children.
2. Measure neutralizing antibody titers against poliovirus type I, II and III at over 18 months of age infants after 2-dose Sabin IPV schedule, compared with 3-dose Sabin IPV schedule.

Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian agree to participate in the follow study.
* The subject was vaccinated either two doses or three doses Sabin IPV ,collected two blood samples and laboratory test results were available per protocol of pervious study
* The subject is at least 18 months age.

Exclusion Criteria:

* Parent or legal guardian does not agree to participate in the follow up study.
* The subject has received any polio vaccine product beyond the protocol of previous study.
Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying ARDS Endotypes

Acute respiratory distress syndrome (ARDS) is a life-threatening condition that causes high mortality (41% to 58%). Previous studies have reported that biomarkers can facilitate phenotypic diagnosis of ARDS, enabling precision treatment of ARDS. Although there were many studies that found some potential therapeutic targets for ARDS, no pharmacotherapies have been validated to treat ARDS. The development of biomarkers to predict the prognosis and monitor the response to treatment would be of interest for selecting patients for specific therapeutic trials. Many recent studies have shown that immune metabolic changes are involved in the pathogenesis of ARDS and may become a new therapeutic target for them. We aimed to identify a panel of immunometabolic and lipidomic biomarkers derived from blood and bronchoalveolar lavage fluid (BALF) which may help differentiate the ARDS endotypes.

PROTOCOL OUTLINE:

This is an observational study. The blood and BALF samples will be collected from patients with ARDS for exosome extraction and transcriptome and metabolomic analysis.

Exosome characterization and differential genes and metabolites will be identified.

Eligibility Criteria:
Inclusion Criteria:

1. Aged \>18 years old;
2. Meet the diagnostic criteria of ARDS according to the Berlin Criteria.

Exclusion Criteria:

1. Aged≤18 years old;
2. Pregnancy;
3. No informed consent;
Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome

To evaluate the safety, tolerance and efficacy of three different dosage regimens of Amphotericin B Lipid Complex (ABLC) compared to Fungizone (Amphotericin B) in patients with AIDS and cryptococcal meningitis.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Intravenous pentamidine for treatment of Pneumocystis carinii pneumonia (PCP) but not for prophylaxis.

Patients must have the following:

* Meet the CDC criteria for diagnosis of AIDS.
* Confirmed episode of acute cryptococcal meningitis.
* Informed consent of the patient or guardian prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Clinical evidence of acute or chronic meningitis due to an agent other than Cryptococcus neoformans.
* History of hypersensitivity/anaphylactoid reaction attributed to amphotericin B.
* Any other concomitant condition which, in the opinion of the investigator, would preclude a patient's participation in the study.

Concurrent Medication:

Excluded:

* Corticosteroids.
* Salicylates or other drugs known to interfere with prostaglandin synthesis except as specified in protocol.
* Zidovudine.
* Investigational agents.
* Interferon.
* Interleukin-2 (IL-2).
* Steroids.
* Isoprinosine.
* Intrathecal Amphotericin B.
* Intravenous Pentamidine PCP prophylaxis (only treatment).

Patients with the following are excluded:

* Clinical evidence of acute or chronic meningitis due to an agent other than Cryptococcus neoformans.
* History of hypersensitivity/anaphylactoid reaction attributed to amphotericin B.
* Inability to obtain appropriate follow-up visits.
* Any other concomitant condition which, in the opinion of the investigator, would preclude a patient's participation in the study.

Prior Medication:

Excluded within 4 weeks of study entry:

* Amphotericin B.
* Excluded within 2 weeks of study entry:
* Any other experimental drug.
The Effects of Zidovudine on the Blood of HIV-Infected Patients

To define the pharmacokinetic parameters (blood levels) of total phosphorylated zidovudine (AZT) in peripheral blood mononuclear cells (PBMC) from HIV-infected patients.

Despite an understanding of the serum (or plasma) pharmacokinetics (blood levels) of AZT, a therapeutic concentration range and optimal dosing interval have not yet been determined.

Despite an understanding of the serum (or plasma) pharmacokinetics (blood levels) of AZT, a therapeutic concentration range and optimal dosing interval have not yet been determined.

Three studies are planned on two separate patient groups. Group (1) Patients who have never taken AZT start on a standard dose of AZT. Blood samples are taken hourly for an 8-hour period on days 1 and 14. Other blood samples are taken on days 2, 4, and 8. Group (2) Patients who have never taken AZT are given a standard dose for the first week, increasing each week until week 5. Blood samples are taken at the end of each weekly treatment. After 4 weeks of standard treatment, patients in groups 1 and 2 return and receive a single morning dose of oral AZT. Blood samples are taken immediately before dosing and at 1, 2, 4, 6, and 8 hours after dosing. After a 48-hour clearance period, patients return and resume dosing. Blood samples are again taken over an 8-hour period. After 24 weeks of standard treatment, the pharmacokinetic studies are repeated.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* FDA-approved anti-pneumocystis and antifungal prophylactic or suppressive regimens.
* Acyclovir for up to 3 weeks intermittently.

Patients must:

* Meet current guidelines for receiving prescription zidovudine.
* Have written informed consent from both subject and parent or guardian if under 18. Be capable of understanding and giving informed consent. Women and minorities are actively encouraged to participate.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Malabsorption syndrome (3 or more loose stools/day for at least 4 weeks associated with unintentional weight loss of greater than 10 percent of body weight).

Concurrent Medication:

Excluded:

* Probenecid or non-FDA approved investigational drugs.
* Systemic chemotherapy.
* Other antiviral agents, licensed or investigational, including ganciclovir, foscarnet, ribavirin, didanosine (ddI), dideoxycytidine (ddC), and dideoxydidehydrothymidine (D4T).

Chronic acyclovir.

-

Patients with the following are excluded:

* Active bacterial, fungal, or viral infection requiring systemic therapy not specifically allowed.
* Significant, chronic medical conditions that could impair compliance with study treatment.

Prior Medication:

Excluded:

* Zidovudine (AZT).
* Systemic chemotherapy within previous 6 months.
* Acyclovir within 30 days of study entry.

Risk Behavior:

Excluded:

* Unable to take oral medication reliably.
* Alcohol or drug abuse that could impair compliance with study treatment.
Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis

A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis

Suitable subjects randomized to the experimental or control group. The subjects eat IP during 7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 19, under 75 of age
* Patients acute bronchitis, sputum symptoms, BSS over 7 points.
* Patients acute bronchitis within 7days.
* Non-pregnant, patients who agree to contraception.
* Patients who can write diary and available to communicate.
* Patients voluntarily agreed

Exclusion Criteria:

* Patients with hypersensitivity to the drug.
* Patients who have gotten systemic steroid treatment within 4 weeks.
* Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days.
* Patients who have gotten treatment of mucus solvents or antitussives within 3 days.
* Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease.
* Patients heart disease, severe kidney, liver disease.
* The bleeding tendency or immunosuppressed patients.
* Patients with clinically significant abnormal values.
* Pregnant women or nursing mothers.
* Patients alcoholics or drug abuse.
* Patients taking other clinical trail's medicines within 30 days.
Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia

Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, associated with standards treatments in COVID-19 (+) patients, Hospitalized In Intensive care in Tunisia.

Multicentric, comparative, randomized study.

Arm1 :

* Usual standard treatment\*
* Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion) a second injection may be considered if necessary, but no more than 800 mg per day. Only on the 1st day (D0)
* Enoxaparin (4000 IU X 2) per day for the duration of hospitalization

VERSUS

Arm 2:

* Usual standard treatment\*
* Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution) by electric syringe 40 mg/kg/day 5day/7 without exceeding 5 g per day for 14 days
* Enoxaparin (4000 IU X 2) per day for the duration of hospitalization

Usual standard treatment\*: according to the standard practices of each center, apart from the active molecules of the 2 arms and their therapeutic class)

Eligibility Criteria:
Inclusion Criteria:

* Patient confirmed COVID19 positive
* Patient with acute respiratory deficiency
* Patient hospitalized in the intensive care unit
* Age \>18 years old
* Having given written consent for their participation in the study

Exclusion Criteria:

* Taking Tocilizumab or hydroxychloroquine deferoxamine within one month prior to inclusion (excluding participation in THINC or COVID_2Pro or COVID+PA studies)
* Severe/severe liver failure
* Dialysis patients
* Renal insufficiency (clearance\< 30ml/min/1.73m2)
* Allergy to deferoxamine
* Pregnant or breastfeeding woman
* Hypersensitivity to the active substance or any of the excipients of Tocilizumab
* A decrease in blood platelets with previous use of enoxaparin or another heparin drug,
* hemophilia and related diseases,
* stomach or duodenal ulcer
PRevention of Acute Kidney Injury Initiated With Electronic Surveillance Enhancement

Introduction: Acute kidney injury (AKI) increases mortality, hospital cost, and rate of progression toward end stage kidney disease 1-4. Early diagnosis and management of AKI is known to improve the above mentioned outcomes.

Hypothesis: the investigators will design and validate an electronic surveillance tool to screen all the ICU admissions for the earlier, more efficient diagnosis of AKI and as a result improve the outcome of AKI in ICU patients.

Methods: the investigators plan to use the patient database, and AKIN (AKI network) definition to design an electronic alert system to allow clinicians discover patients who develop AKI. Then a randomized clinical trial will be conducted to compare earlier intervention (based on Kidney Disease: Improving Global Outcomes \[KDIGO\] guidelines) initiated by AKI sniffer alert to the conventional management provided by primary physician in ICU.

A prospective controlled, unblinded clinical trial will be conducted among AKI patients who are detected by the use of AKI sniffer. The investigators will randomize consecutive patients who were detected to have AKI by AKI sniffer into two groups. In one group (control group), patients will receive standard clinical care by the primary ICU physicians. The primary physicians who take care of the control subjects will be kept blinded of the results of the AKI sniffer. All the ICU physicians will receive a copy of KDIGO (March 2012) guidelines for management of AKI prior to the initiation of the patient accrual. In the intervention group, the research team will inform the primary care team about the occurrence of the AKI and provides a copy of KDIGO guidelines for management of AKI to the clinicians. Each subject will be followed until hospital discharge or for a maximum of 3 months, for clinical and laboratory data including peak serum creatinine, creatinine at the end of follow up, peak AKIN stage, along with other secondary outcomes. The investigators will exclude the prevalent cases (AKI patients who have had AKI documented in their medical records by clinicians prior to the ICU admission).

Eligibility Criteria:
Inclusion Criteria:

* All patients who are admitted in adult ICUs in Mayo Clinic Rochester
* Foley catheter for hourly UOP measurement

Exclusion Criteria:

* Prisoners
* Patients less than 18 years old.
* Lack of research authorization (in control group)
* ESRD on dialysis or s/p kidney transplantation
* Known AKI before admission to ICU
* Moribund patients
* Prevalent AKI admission in ICU (patients who have diagnosis of AKI documented in their medical records prior to ICU admission)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Subcutaneous Doses of ABBV-701 in Healthy Adult Western and Asian Participants

The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous (SC) ABBV-701 in healthy adult western and Asian participants.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
* Part 2 only:

For Japanese Participants:

--Participant must be first or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.

Han Chinese Participants:

--Participant must be first or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.

Exclusion Criteria:

* History of any clinically significant cardiovascular, respiratory (except mild asthma as a child), renal, endocrine, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of any clinically significant sensitivity or allergy to any medication or food.
Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.

Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.

Eligibility Criteria:
Key Inclusion Criteria:

* Understand and sign an IRB/IEC approved Informed Consent form.
* Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
* Successful wear of frequent replacement, spherical, daily wear soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Manifest cylinder ≤ 0.75 diopter (D) in each eye.
* Best spectacle corrected visual acuity 20/20 or better in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Monovision contact lens wear.
* Any habitual wear of Biofinity lenses.
* Other protocol-defined exclusion criteria may apply.