louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00842010: Characteristics of Non Diabetic Hyperglycemic Inpatients
Official title: Hyperglycemic Non Diabetic (HND) Hospital Patients: Are They Different From Diabetic Hyperglycemic and Non-Hyperglycemic Non-Diabetic(NHND) Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes
Inpatient
Hospital
Hyperglycemia
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2009-02-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nested sample obtained from patients admitted to John H. Stroger Jr. Hospital from March-April 2006 and in October 2007.

Brief summary: Retrospective nested non-matched case control study comparing patients by glycemic status

Detailed description: This retrospective nested non-matched case control study compared patients directly admitted to the General Medicine Wards, not transferred from ICU with

* hyperglycemia on admission but no previous diagnosis of diabetes
* diabetic hyperglycemic patients
* non hyperglycemic non diabetic patients from the same nested population.

The investigators' hypothesis is that the clinical characteristics and endpoints of the non diabetic hyperglycemics should be similar to the diabetic population and different from the non diabetic non hyperglycemic population.

Eligibility criteria: Inclusion Criteria:

* Admitted to John H. Stroger Jr. Hospital
* Admitted to Internal Medicine Service from March-April 2006 and in October 2007

Exclusion Criteria:

* Transfer from any intensive care unit (medical or surgical)

Primary outcomes:
measure: Length of stay
timeFrame: Measured 24 hours after patient is discharged. From day 1 of admission until day of discharge
measure: Inpatient Mortality
timeFrame: From day 1 of admission until day of discharge
Secondary outcomes:
measure: Frequency of SIRS on admission
timeFrame: Measures obtained 24 hours after patient is discharged. Clinical data obtained on day 1 of admission
measure: Frequency of inpatient infection
timeFrame: From day 1 of admission until day of discharge
measure: Rate of use of intravenous glucose drip
timeFrame: From day 1 of admission until day of discharge
measure: Frequency of steroid use
timeFrame: From day 1 of admission until day of discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H. Stroger Jr. Hospital
state: Illinois
Study officials:
affiliation: John H. Stroger Jr. Hospital
name: Evelyn Lacuesta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: John H. Stroger Jr. Hospital
name: Jyothsna Palla, MD
role: STUDY_CHAIR
affiliation: Rush University Hospital, John H. Stroger Jr. Hospital
name: Yannis Guerra, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01338610: ESBA105 in Patients With Severe Dry Eye
Official title: Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eyes Dry Chronic
Keywords: Ocular discomfort
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.

Detailed description: Following Run-In, patients qualifying for treatment were randomized 2:1 to receive ESBA105 (experimental group) or Vehicle (control group) for 4 weeks. Patients not qualifying for treatment (based on global VAS discomfort score), were discontinued from the study.

Eligibility criteria: Inclusion Criteria:

* Ongoing physician diagnosis of dry eye for at least 6 months.
* Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis.
* Experience persistent ocular discomfort.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Contact lens wearers.
* Severe Sjogren's Syndrome.
* History of corneal surgery including refractive surgeries.
* Intraocular surgery within 6 months of Visit 1.
* Intraocular or periocular injection within 6 months of Visit 1.
* Lid function abnormalities.
* Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
* Any acute infectious or non-infectious ocular condition of the anterior or posterior segments in either eye within 30 days of Visit 1.
* Diseases/conditions of ocular surface associated with clinically significant scarring/destruction of conjunctiva/cornea.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28
timeFrame: Up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT01420510: Saginil in vs. Placebo for Gynecologic Oncology Patients Affected by Vaginitis
Official title: Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Vaginitis
Keywords: Patients satisfaction
Side effects
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2011-08-19
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We hypothesise that the use of Adelmidrol (Saginil in vaginal cannulas) can reduce the incidence and magnitude of vaginitis in patients affected by gynecologic malignancies.


Eligibility criteria: Inclusion Criteria:

* Gynecologic malignancy
* Current administration of chemotherapy

Exclusion Criteria:

* Colpectomy
* Vaginal cancer
* Vulvar cancer
* Bacterial vaginitis

Primary outcomes:
measure: Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Gynecologic Oncology Unit
Study officials:
References:
Clinical trial NCT00286910: Urinary Aquaporin 2 and Expression of the NPHS2 Gene in Adults Suffering From Nephrotic Syndrome
Official title: Urinary Aquaporin 2 and Expression of the NPHS2 Gene in Adults Suffering From Nephrotic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrotic Syndrome
Keywords: AQP-2
NPHS2-gene
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-02-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients with nephrotic syndrome healthy volunteers

Brief summary: We want to test the hypothesises that patients with nephrotic syndrome have a higher excretion of AQP2 in the urine,that they have a higher concentration of AVP,and a lower C-H2O.Everything will normalize, when the syndrome is in remission.Furthermore we want to test the hypothesis that the expression of mutations in the NPHS2-gene,that codes for podocin,will cause a lack off or a poorer response in the treatment of nephrotic syndrome


Eligibility criteria: Inclusion Criteria:

adult patients with nephrotic syndrome in the years 1995 until now; both male and female; the kidney disease must be based upon a kidney biopsy ; age \> 18 years -

Exclusion Criteria:

severe diseases in the heart, lungs or liver; diabetes mellitus; other not well-treated diseases in endocrine organs; cancer unwillingness to participate

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medicine, Holstebro Hospital
Study officials:
affiliation: Holstebro Hospital, Denmark
name: Erling B Pedersen, professor
role: STUDY_CHAIR
References:
Clinical trial NCT00614510: SynCardia CardioWest TAH-t Postmarket Surveillance Study
Official title: The SynCardia CardioWest Temporary Total Artificial Heart (TAH-t) Postmarket Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biventricular Failure
Lead sponsor: SynCardia Systems. LLC
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been or will be implanted with the SynCardia Total Artificial Heart.

Brief summary: The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training defined in the SynCardia Systems, Inc. Training Manual and who enroll subjects who meet the intended use defined in the product Instructions for Use.


Eligibility criteria: Inclusion Criteria:

* The TAH-t is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

Exclusion Criteria:

* Patients who are not cardiac transplant eligible.
* Patients who do not have sufficient space in the chest area vacated by the natural ventricles. Generally this includes patients who have body surface areas \<1.7m², or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) \< 10 cm.
* Patients who cannot be adequately anticoagulated on the TAH-t.

Primary outcomes:
measure: Subject survival at 30-days and one-year post transplant
timeFrame: 30-days and one-year post transplant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center
name: Jack G Copeland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05143710: The Clinical and Prognostic Features of PRES
Official title: The Features of Clinical Imaging, Disease Severity and Pregnancy Outcomes in Posterior Reversible Encephalopathy Syndrome With Preeclampsia or Eclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posterior Reversible Encephalopathy Syndrome
Pregnancy Outcomes
Preeclampsia
Eclampsia
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 354
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant woman diagnosed with PRES with preeclampsia or eclampsia

Brief summary: The purpose of this study is to determine the features of clinical imaging, disease severity and pregnancy outcomes in posterior reversible encephalopathy syndrome with preeclampsia or eclampsia.

Detailed description: The investigators retrospectively collected data (General information, clinical data, biochemical indicators, imaging features, and pregnancy outcome) from pregnant woman diagnosed with PRES with preeclampsia or eclampsia to analyze features of clinical imaging, disease severity and pregnancy outcomes during 2012 to 2021.Then, the investigators grouped all the patients into early onset group and late onset PE group according to gestational weeks to analyze differences of clinical imaging. Finally, the investigators grouped all the patients into good pregnancy outcomes group and poor pregnancy outcomes group according to diagnostic criteria, including the incidence of stillbirth and premature birth, to analyze differences of clinical imaging .

Eligibility criteria: Inclusion Criteria:

1. patients were diagnosed of PRES with PE or E
2. all patients provided written informed consent

Exclusion Criteria:

1. patients combined with other neurological disorders
2. patients combined with mental illness

Primary outcomes:
measure: features of clinical imaging
timeFrame: Cranial Imaging was examined immediately at the onset of symptoms, such as s headaches, visual changes, seizures, consciousness impairment, mental disorders, and focal neurological deficits.
measure: blood pressure(BP)
timeFrame: The BP of patients was obtained immediately at the onset of symptoms.
measure: biochemical parameters
timeFrame: Biochemical indicators were collected within 1 week of the hospital stay.
measure: pregnancy outcomes
timeFrame: The pregnancy outcomes will record immediately when the patients deliver.
measure: pregnancy outcomes
timeFrame: From day of admission until the day of discharge or date of death from any cause,whichever came first,assessed up to 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University
Study officials:
References:
Clinical trial NCT06542510: The Impact of Working Night Shifts on Cardiac Autonomic Nervous Regulation During the Six-minute Walk Test in Nurses
Official title: The Impact of Working Night Shifts on Cardiac Autonomic Nervous Regulation During the Six-minute Walk Test in Nurses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autonomic Nervous System Imbalance
Keywords: heart rate variability; night shift; autonomic nervous system; six-minute walk test; nurses
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants were nurses from Nanfang Hospital of Southern Medical University who worked ward shifts. The nurses in this study had one night shift every 5-10 days, from 00:00 a.m. to 8:00 a.m., followed by 2-3 days off.

Brief summary: To evaluate changes in heart rate variability (HRV) after the six-minute walk test (6MWT) in nurses following a night shift and explore the impact of night shift work on the regulation of the autonomic nervous system in the heart.

Thirty-five female nurses, with a mean age of 28.7 years (range 21.0-37.0 years), participated in this study. On the first and second mornings after a night shift, the nurses performed the 6MWT. During the test, electrocardiogram (ECG) signals, blood pressure, and walking distance were recorded simultaneously.


Eligibility criteria: Inclusion Criteria:

* Female nurses aged ≥ 18 years who had undergone annual physical examinations, did not have serious cardiopulmonary diseases, and were able to walk normally were considered for inclusion in the study.

Exclusion Criteria:

* (ⅰ) having children at home who require night care; (ⅱ) current pregnancy; (ⅲ) engaging in activities that significantly impact heart rate, such as sexual activity, 24 hours before and 24 hours after working night shifts; (ⅳ) history of thyroid dysfunction, hypertension, diabetes, coronary heart disease, etc.; (ⅴ) experiencing upper respiratory tract infection, fever, cough, diarrhea, or other illnesses within 1 week before the planned enrollment; (ⅵ) consuming coffee or strong tea, smoking, drinking alcohol, or using other substances that affect heart rate 3 days before the planned enrollment; (ⅶ) taking β-receptor blockers, sleeping pills, psychotropic drugs, or other medications that affect heart rate; and (ⅷ) judged by the investigator to be unsuitable for participation in this study.

Primary outcomes:
measure: Delta HRV during the 6MWT
timeFrame: 18 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT03071510: Evaluation of the Atlas Genetics io® CTNG System
Official title: IO-CTNG: A Multi-Centre Evaluation of the Atlas Genetics io® CTNG System Used in Centralised and Point of Care Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chlamydia Trachomatis
Gonorrhea
Lead sponsor: Binx Health Limited
Sponsor class: INDUSTRY
First posted: 2017-03-07
Enrollment: 7128
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants over 14 years of age for whom testing for Chlamydia trachomatis and/or Neisseria gonorrhoeae is appropriate

Brief summary: Atlas Genetics io® system results are compared with those obtained from comparator devices.

Detailed description: Results from the Atlas Genetics io® system are compared with a Composite Infection Status obtained from testing on three commonly used comparator devices.

This is a prospective, single-arm, multi-centre investigation enrolling up to 12,000 adult participants over 14 years of age who are undergoing testing for the presence of CT/NG.

Eligibility criteria: Inclusion Criteria:

1. Symptomatic and asymptomatic individuals ≥14 years of age

Exclusion Criteria:

1. Treatment with antibiotics known to be effective against Chlamydia trachomatis and/or Neisseria gonorrhoeae within the previous 4 weeks before inclusion in the study.
2. Unable to self-obtain a vaginal swab or urine sample of at least 30 mL

Primary outcomes:
measure: Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices
timeFrame: Up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Greensboro
country: United States
facility: Wake Forest Center for Reproductive Medicine
state: North Carolina
city: Philadelphia
country: United States
facility: Planned Parenthood Southeastern Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Planned Parenthood Gulf Coast
state: Texas
Study officials:
affiliation: University of Alabama at Birmingham
name: Barbara Van der Pol, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04725110: Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome
Official title: Phase II Trial of Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 ARDS - A Multi-Site, Randomized, Double-blinded, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Covid19
SARS-CoV Infection
ARDS
ARDS, Human
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.

Detailed description: Post-hospitalization follow-up for 6 and 12-months of survival and end-organ dysfunction (lung, heart, kidney, neuropsychological), plus quality of life and return to work of those previously working

Eligibility criteria: Exclusion Criteria:

* Pregnancy

Inclusion Criteria:

* Diagnosis of SARS-CoV-2 with first positive test within 14 days, and,
* Diagnosis of ARDS by the Berlin Criteria (2012):

  1. Onset: \< 7 days
  2. Chest x-ray: Bilateral Patchy Opacities, Infiltrates
  3. Mechanical Vent Support: PEEP or CPAP Support \>= 5 cm H2O
  4. Pulmonary Edema: Not fully explained by cardiogenic etiology
  5. Hypoxia: PaO2/FIO2 Ratio \< 300, or O2Sat/FIO2 Ratio \< 315

Primary outcomes:
measure: Change Extravascular Lung Water Index
timeFrame: 1 hour
Secondary outcomes:
measure: Length of ICU Stay
timeFrame: Baseline to ICU discharge up to 30 days
measure: Number of Ventilator-Free Days
timeFrame: 30 days
measure: 30-day Survival
timeFrame: 30 days
measure: Creatinine Concentration
timeFrame: 4 days
measure: Glomerular Filtration Rate
timeFrame: 4 days
measure: New York Heart Association (NYHA) Functional Classification
timeFrame: 30 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Timothy P Rich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: David Ingbar, MD
role: STUDY_CHAIR
References: