louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05964088: Mortality and Morbidity Associated With New Onset Acute Kidney Injury in Critically Ill COVID-19 Infection Patients
Official title: Mortality and Morbidity Associated With New Onset Acute Kidney Injury in Critically Ill COVID-19 Infection Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Arrowhead Regional Medical Center
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a two-year retrospective study of critically ill adult patients infected with COVID-19 that were admitted to the intensive care unit on ventilatory support. Patients included in this study were admitted to Arrowhead Regional Medical Center (ARMC) from March 1, 2020 to February 12, 2022.

Brief summary: This study explored the incidence of morbidity and mortality associated with AKI in critically ill adult patients infected with COVID-19. There are two groups for comparison. Group1. patients were directly admitted to the intensive care unit (ICU) from the emergency department (ED) Group 2. patients were initially managed on the medical floor and later transferred to the ICU for worsening respiratory status. The investigating team evaluated the correlation of inflammatory markers and common risk factors such as obesity, diabetes, hypertension and ethnicity to the development of AKI in the target population. The primary outcome is mortality participants will received their regular healthcare in a medical setting


Eligibility criteria: Inclusion Criteria:

positive for SARS-CoV-2 on a real-time polymerase chain reaction test (RT-PCR) upon admission to the hospital

Exclusion Criteria:

chronic kidney disease end stage renal disease

Primary outcomes:
measure: Mortality
timeFrame: from admission until death from any cause, whichever comes first, assessed up to three months
Secondary outcomes:
Other outcomes:
Locations:
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
Study officials:
affiliation: Arrowhead Regional Medical Center
name: Michael M Neeki, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06053788: PocDoc Lipids Usability Study for Self-test Use
Official title: PocDoc Lipids Usability Study for Self-test Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Lead sponsor: Vital Signs Solutions Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study seeks to expand the approved indication of use for a UKCA approved IVD device. PocDoc lipids is approved for professional use to measure the levels of lipids in a fingerprick blood samples. This study will investigate the usability of the device by untrained lay people in order to expand the device's utility to the self-test setting.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Subjects are legally competent and capable to understand character, meaning and consequences of the study
* Subjects own an approved mobile device (these will be available at the time of the study on the PocDoc website and a link will be contained in the PIS)

Exclusion Criteria:

* Being unable to give informed consent
* \< 18 years or \> 85 years
* Legally incompetent
* Language barriers potentially compromising an adequate compliance with study procedures

Primary outcomes:
measure: Usability
timeFrame: Day 1 - one single test done at one timepoint
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Vital Signs Solutions Ltd
Study officials:
References:
Clinical trial NCT01268488: Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting
Official title: Clinical Trial Protocol for NINJA 2 System With CONTOUR Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2010-12-31
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age and above
* Type 1 or type 2 diabetes
* Currently self-testing blood glucose at home at least twice daily
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Currently Pregnant
* Hemophilia or any other bleeding disorder
* Employee of competitive medical device company
* Cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study

Primary outcomes:
measure: Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
timeFrame: 2 hours
Secondary outcomes:
measure: Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
timeFrame: 2 hours
measure: Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)
timeFrame: 2 hours
measure: Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
timeFrame: 2 hours
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Consumer Product Testing Company
state: New Jersey
Study officials:
affiliation: Consumer Product Testing Company
name: Michael Caswell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05844488: DIGITAL Biomarker: Blood Based Biomarkers in the Primary Care Setting for Alzheimer's Disease
Official title: DIGITAL Biomarker: Blood Based Biomarkers in the Primary Care Setting for Timely and Accurate Diagnosis of Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Davos Alzheimer's Collaborative
name: Regenstrief Institute, Inc.
First posted: 2023-05-06
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients who do not complete a DCA screening for any reason
* Existing diagnosis of dementia documented in their medical record based on ICD-10 codes

Brief summary: The primary objective of this study is to evaluate the feasibility of implementing blood-based biomarker testing for amyloid positivity designed to aid the early detection of Alzheimer's Disease and Related Dementia (ADRD) in patients 65+ including the rate that patients and providers follow up abnormal blood-based biomarker testing.

Detailed description: This study is conducted to evaluate whether a new approach to screening patients for cognitive decline in primary care practices helps with earlier detection of Alzheimer's Disease. As part of the study, the provider subjects will receive training about the PrecivityAD blood biomarker test offered by C2N Diagnostics. They will be able to order the PrecivityAD test for possible Alzheimer's disease if their patient has an abnormal screening for cognitive impairment and consents to this study. Patient subjects will have their blood drawn (1 teaspoon) for the PrecivityAD blood test and will be asked to complete a surveys before and after the blood drawn. They will receive follow up phone calls within 1 to 4 weeks after they discuss the results of their blood test with their primary care.

Eligibility criteria: Inclusion Criteria:

* Patients must be \> 65 years of age
* Any gender
* Is an established or new patient at one of the 6 participating IUHP PC sites
* Is able to provide informed consent (research portion only for the biomarker consent) or has a Legally Authorized Representative (LAR) who can provide informed consent
* Has a "red" DCA screening in the last 12 months (a score of 0 or 1 out of 5)

Exclusion Criteria:

* Patients who do not complete a DCA screening for any reason
* Existing diagnosis of dementia documented in their medical record based on ICD-10 codes

Primary outcomes:
measure: Number of Patients who are willing to have Blood Based Biomarkers Performed
timeFrame: Mar 31, 2023 to May 31, 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Physicians Primary Care
state: Indiana
Study officials:
References:
Clinical trial NCT03742388: A Genomic Analysis of Evolution of Epithelia Ovarian Tumors
Official title: A Genomic Analysis on the Evolution of Epithelia Ovarian Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epithelial Ovarian Cancer
Epithelial Ovarian Tumor of Borderline Malignancy
Driving Mutations
Progression-free Survival
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with diagnosis of primary epithelial ovarian borderline tumor with cancer will be included.

Brief summary: Epithelial ovarian carcinomatous and borderline components sometimes appeared in one patient. This study aims to analyze the genomic patterns of the carcinomatous and borderline components in the ovarian epithelial tissues. These tissues will be collected from paraffin section by microdissection to distinguish normal, carcinomatous and borderline tissues.


Eligibility criteria: Inclusion Criteria:

* Confirmed primary epithelial ovarian borderline tumor with cancer
* Signed an approved informed consents
* Feasible for sampling

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Frequencies of somatic driving mutations
timeFrame: Two years
Secondary outcomes:
measure: Progression-free survival
timeFrame: Five years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05672888: Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.
Official title: Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19 Pneumonia
Keywords: Pneumonia
COVID-19 Infection
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 60
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: This was a randomized, double-blind, placebo-controlled parallel study.


Eligibility criteria: Inclusion Criteria:

* 18 years of age, male or female;
* History of COVID-19 infection within 1 week;
* Subjects with HRCT consistent with viral pneumonia (Judged by investigator) and meeting any of the following criteria: With fever, respiratory symptoms; Shortness of breath present,RR ≥30 breaths/min.
* Clear consciousness, Capable and voluntary informed consent.

Exclusion Criteria:

* Unable to take tablets orally Or suspected hypersensitivity to Jaktinib, drugs of the same class, or their excipients, Patients with severe gastrointestinal dysfunction affecting drug absorption;
* Any person meeting criteria for critical pneumonia;
* Patients considered unsuitable for this trial by the investigator.

Primary outcomes:
measure: Time to Recovery
timeFrame: Day 1 to Day 28
Secondary outcomes:
measure: Percentage of participants who require invasive mechanical ventilation due to disease progression at Day 3, 7, 1 4 or EOT
timeFrame: Day 3, 7, 14 or EOT
measure: Mortality
timeFrame: Day 1 to Day 28
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Jianya Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00424788: A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
Official title: A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Relapsing Forms of Multiple Sclerosis
Keywords: multiple sclerosis (MS)
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-01-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Natalizumab (TYSABRI) is a protein-based drug that is manufactured by Biogen Idec in partnership with Elan Pharmaceuticals. Natalizumab is approved in the US and Europe for the treatment of Multiple Sclerosis (MS). The purpose of this study is to determine whether the amount of natalizumab (TYSABRI) that is present in your blood (plasma) can be reduced or eliminated by separating and removing the plasma and replacing it with other fluids, a process called plasma exchange.


Eligibility criteria: Inclusion Criteria:

* considered by the Investigator to be free of signs and symptoms suggestive of any serious opportunistic infection
* willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including interferon beta and glatiramer acetate) for the duration of the study
* willing and able to comply with the site's plasma exchange protocol which may require hospitalization or daily visits

Exclusion Criteria:

* considered by the Investigator to be immunocompromised
* history of, or available abnormal laboratory results indicative of any major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent for the duration of the study.
* condition(s) considered to be contraindication(s) for plasma exchange, including but not limited to bleeding diathesis, hypotension, or vascular access limitations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Mellen Center for MS
state: Ohio
city: Milwaukee
country: United States
facility: Center for Neurological Disorders, Aurora Health Care
state: Wisconsin
Study officials:
affiliation: Biogen
name: Michael Panzara, MD MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT05460988: "Re-instrumentation vs Flap Surgery"
Official title: "Re-instrumentation vs Flap Surgery in Residual Pockets: a RCT on Clinical Efficacy"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Pocket
Periodontitis
Keywords: non-surgical periodontal therapy
re-instrumentation
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 46
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: There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets.

The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated


Eligibility criteria: Inclusion Criteria:

* Age ≥18aa
* Patients with periodontal disease
* Less than 20 cigarettes/day
* No systemic antibiotic therapy in the last 3 months
* At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray
* Full-mouth plaque score and full-mouth bleeding score \<15% at baseline (re-evaluation) measured at six sites per tooth
* No previous periodontal surgery at the experimental tooth

Exclusion Criteria:

* Connective tissue diseases
* Diabetes
* Pregnancy or lactating
* Furcation involvement
* Crowned tooth
* Severe tooth mobility (class III)
* Radiographical horizontal bone resorption exceeding the 50% of the root

Primary outcomes:
measure: PD change
timeFrame: 3 months after the procedure
measure: PD change
timeFrame: 6 months after the procedure
measure: PD change
timeFrame: 12 months after the procedure
Secondary outcomes:
measure: CAL change
timeFrame: 3 months after the procedure
measure: CAL change
timeFrame: 6 months after the procedure
measure: CAL change
timeFrame: 12 months after the procedure
Other outcomes:
Locations:
city: Florence
country: Italy
facility: University of Florence
Study officials:
References:
Clinical trial NCT00006488: Continuously Infused Intracerebral (IC) Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (r-metHuGDNF) for the Treatment of Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-11-09
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Parkinson's disease is characterized by loss of neurons that produce dopamine in a region of the brain called the substantia nigra. In the early stages of the disease, the disease responds to agents that replace dopamine such as levodopa. Patients with more advanced disease have wide fluctuations in their response to levodopa, exhibiting on and off periods. This is due to continued degeneration of neurons. Recombinant-methionyl human glial cell line-derived neurotrophic factor (r-metHuGDNF or GDNF) is a neurotrophic factor that promotes survival of dopaminergic neurons. This is a protein produced by recombinant technology that is almost identical to the naturally produced factor. Results of animal studies indicate that GDNF has the potential to benefit patients with advanced Parkinson's disease.

The purpose of this clinical trial is to determine whether GDNF works to relieve symptoms of advanced Parkinson's disease. The study will also test the delivery of GDNF using a catheter implanted into the putamen, the area of the brain associated with Parkinson's disease, and an infusion pump that is implanted under the skin in the abdomen or chest. GDNF will be placed into the pump and delivered through the catheter to the brain. The purposes of this study are to determine the potential benefits and side effects of GDNF. The performance and safety of the catheter/infusion pump system will also be assessed. The study will last for 6 months. Subjects will undergo neurological testing, computerized gait assessment and neurological imaging.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced idiopathic Parkinson's disease treated with optimal doses of levodopa, dopamine agonist, catechol-o-methyl transferase (COMT) inhibitors, or selegiline for 2 months prior to implantation of the intracerebral catheter and pump.
* Must be able to undergo surgery required to implant the pump and catheter.
* Must be capable of informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Neurology
state: New York
Study officials:
References:
Clinical trial NCT01388088: The Effect of Amiloride and Spironolactone in Patients With Hypertension
Official title: Effect of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables in Patients With Essential Hypertension in a Doublle-blinded Randomised Placebo-controlled, Cross-over Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Potassium
Blood-pressure
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 23
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators wish to investigate the potential effects of potassium. In this study we will examine patients with hypertension and increase their potassium-levels using Amiloride and Spironolactone.

The investigators will examine the changes in the cardiovascular system using a Sphygmocor-scanner.

Detailed description: Purpose of the study is to examine the effect of amilorid and spironolacton on

1. Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
2. Pulsewavevelocity, augmentation index and centralt bloodpressure,
3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
4. Ambulatory blood pressure

Eligibility criteria: Inclusion Criteria:

* Hypertension
* Age 45-70
* BMI: 18,5-30

Exclusion Criteria:

* Other diseases
* Drug or alcohol abuse
* Abnormal findings in the screening procedure

Primary outcomes:
measure: Blood pressure
timeFrame: 2 years
Secondary outcomes:
measure: Pulse wave velocity
timeFrame: 2 years
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research
Study officials:
affiliation: Medical Research Department
name: Solveig K Matthesen, Cand.Med
role: PRINCIPAL_INVESTIGATOR
References: