louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00192894: New Methods to Detect a Decrease in Heart Function
Official title: Cardiac Output Changes During Onset of Spinal Anesthesia in Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
name: Oberstinde Kirsten Jensa la Cours Foundation
First posted: 2005-09-19
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients undergoing spinal anaesthesia

Brief summary: The purpose of this study was to evaluate the changes in heart function during onset of spinal anesthesia using a new and less invasive method, the LidcoTMplus.

Detailed description: The incidence of hypotension during onset of spinal anesthesia in elderly patients varies from 27% to 80% depending on which definition being used. Studies of cardiac output (CO) has shown that it is maintained or only slightly decreased .

Unfortunately, the time-resolution in these studies is often several minutes, and the description of changes is consequently often a start-to-end relation rather than a description of the dynamic changes during onset of spinal anesthesia.

A recent advance in measuring CO is the LiDCOTMplus hemodynamic monitor, which has proved reliable compared to pulmonary artery catheters in various intensive care settings. This monitor allows for beat-to-beat measuring during various procedures and thus early warning of hemodynamic events.

Another method with potential for early warning of decreased perfusion is near-infrared spectroscopy (NIRS). NIRS is used for continuous and non-invasive monitoring of cerebral oxygen saturation (ScO2) and even a small reduction has recently shown to predict maternal hypotension during caesarian section.

The aim of our study was to describe the changes in CO during onset of spinal anesthesia in elderly patients using a method with high time-resolution. We also attempted to evaluate NIRS as predictor of hemodynamic events.

Eligibility criteria: Inclusion Criteria:

* Age 60 years or older
* Elective orthopedic or plastic lower limp surgery
* in spinal anesthesia

Exclusion Criteria:

* Body weight \<40 kg
* Currently in treatment with lithium
* Evidence of aortic valve regurgitation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of anaesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Department of anaesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
name: Lars S. Rasmussen, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01301794: Lovaza Mechanisms of Action
Official title: Study of the Effects of Lovaza (Omega 3 Fatty Acids) On Lipoprotein Particles and Their Transcriptional Effects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Moderate Hypertriglyceridemia.
Keywords: Hypertriglyceridemia
Fish oil
Omega 3 fatty acids
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: High levels of triglycerides is a common abnormality found in patients with diabetes and also cardiovascular disease, and may contribute to the risk for both. Omega 3 fatty acids, as found enriched in fish and also in the commercial agent called Lovaza lower triglyceride levels. Prior work from the investigators group demonstrated that an enzyme responsible for the break down of triglycerides - lipoprotein lipase - generates molecules that can activate a specific nuclear receptor known as PPAR-alpha. This study investigates the hypothesis that taking Lovaza shifts the specific fatty acid content of triglyceride containing lipoproteins and increases the ability of those lipoproteins to activate PPAR-alpha.

Detailed description: This study will investigate changes in lipid and other metabolic parameters as well as the ability of isolated lipoproteins to activate PPARs in the presence or absence of lipoprotein lipase in a cohort of normal healthy individuals with modest hypertriglyceridemia before and after a course of Lovaza.

Eligibility criteria: Inclusion Criteria:

* Otherwise healthy 21 to 65 year old men and women
* Triglycerides \>150 \< 500 mg/dL

Exclusion Criteria:

* Other lipid lowering medication including fish oil
* Major illnesses
* Diabetes
* Cardiovascular disease
* Abnormalities uncovered on screening blood work including undiagnosed diabetes, abnormal liver function tests, triglycerides \> 500 mg/dL
* Indication for immediate statin therapy
* Pregnancy
* Contraindication for fish oil use or muscle biopsy

Primary outcomes:
measure: Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system.
timeFrame: 3 months
Secondary outcomes:
measure: Changes in plasma markers for atherosclerosis
timeFrame: 3 months
measure: Change in plasma markers of diabetes
timeFrame: 3 months
measure: Changes in plasma markers of liver function
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jorge Plutzky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Jonathan Brown, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00273494: Neoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2
Official title: Scandinavian Neoadjuvant Phase III Study of Induction Chemotherapy Followed by Irradiation Alone or Surgery Plus Irradiation in NSCLC Stage IIIA/N2 (T1N2, T2N2, T3/N2).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: N2 disease
Non-small cell lung cancer
Surgery
Neoadjuvant chemotherapy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis is that surgery is of benefit in locally advanced NSCLC with N2 disease.

Patients are randomised to surgery or not.

Detailed description: Patients are after staging randomised to neoadj. chemotherapy followed by surgery followed by irradiation or to chemotherapy followed by irradiation.

Endpoint is survival.

Eligibility criteria: Inclusion Criteria:

* Histologically verified NSCLC
* Stage IIIA/N2
* age 18-75
* Lung function test allowing surgery
* Mediastinoscopy performed

Exclusion Criteria:

* Prior chemotherapy
* Prior irradiation

Primary outcomes:
measure: Survival
Secondary outcomes:
measure: time to progression
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. Oncology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jens B. Sorensen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04395794: SARS-CoV-2 Disguise Study
Official title: SARS-CoV-2 Positive Carriers Among Asymptomatic meDIcal employeeS in hiGh-volUme cardIovaScular cEnter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV2
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2020-05-20
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asymptomatic medical employees in high-volume cardiovascular center

Brief summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is a pandemic disease with worldwide spreading. Limited data are existed regarding SARS-CoV-2 positive carriers among asymptomatic medical employees in non-profile infectious clinic, e.g. cardiovascular clinic, routinely working in the pandemic region with two million inhabitants. The aim is to test the percentage and increase of the SARS-CoV-2 positive carriers among asymptomatic medical employees in high-volume cardiovascular center in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic medical employees of E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
* Filled questionnaire before SARS-CoV-2 testing
* Nasopharyngeal and oropharyngeal testing for SARS-CoV-2
* Signed informed consent

Exclusion Criteria:

* Unwilling to participate

Primary outcomes:
measure: SARS-CoV-2 positive test
timeFrame: 8 weeks
Secondary outcomes:
measure: Transformation
timeFrame: 8 weeks
measure: Predictors (asymptomatic)
timeFrame: 8 weeks
measure: Predictors (symptomatic)
timeFrame: 8 weeks
measure: Percentage from different departments
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Meshalkin National Medical Research Center
Study officials:
References:
Clinical trial NCT00691860: Use of a Mesh to Prevent Parastomal Hernia
Official title: Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parastomal Hernia
Keywords: Parastomal hernias
Tolerance of lightweight meshes
Paracolostomy hernias
Peristomal hernias
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity


Eligibility criteria: Inclusion Criteria:

* patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum,
* Aged over 18,
* Charlson comorbidity index below 7
* Elective surgery
* Radical surgery

Exclusion Criteria:

* Loop colostomies,
* Emergency surgery,
* Body mass index above 35 kg/sq.m.,
* Palliative surgery,
* Hepatic cirrhosis,
* Severe COPD (requiring home oxygen treatment),
* Corticoid treatment

Primary outcomes:
measure: the reduction in the incidence of Parastomal Hernia after the mesh placement
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Corporacio Sanitaria Parc Tauli
name: Salvador Navarro-Soto, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06758960: Analysis of Biological Progression and Regression of HELLP Syndrome in Time
Official title: Biological Evolution of HELLP Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HELLP Syndrome
Preeclampsia
Keywords: Preeclampsia
HELLP syndrome
Thrombocytopenia
Maternal mortality
Lead sponsor: CHU Mohammed VI Marrakech
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 70
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: Pregnant patients admitted to the maternal ICU from the Obstetrics Emergency department of marrakesh

Brief summary: Prospective observational study about progression and regression of biological parameters of HELLP syndrome

Detailed description: Data collection included a comprehensive review of pathological histories, identification of complications based on clinical presentation, daily monitoring of biological parameters, documentation of transfusion events, recording of corticosteroid administration according to gestational age, and detailed reporting of extraction and analgesia techniques.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who are admitted to the maternal ICU for a biological HELLP syndrome

Exclusion Criteria:

* Patients whose biological presentation was attributable to other conditions, such as microangiopathies or leukemia.
* Patients who benefited from plasma exchange therapy

Primary outcomes:
measure: Platelets count
timeFrame: Up to 10 days
Secondary outcomes:
measure: Concentration of Lactate dehydrogenase
timeFrame: Up to 10 days
measure: Concentration of Liver enzymes
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Marrakech
country: Morocco
facility: CHU Mohammed VI of Marrakech
state: Marrakech - Safi
Study officials:
affiliation: CHU Mohammed VI Marrakech
name: Meryem Essafti, Assistant Professor
role: STUDY_DIRECTOR
References:
citation: Martin JN Jr, Blake PG, Lowry SL, Perry KG Jr, Files JC, Morrison JC. Pregnancy complicated by preeclampsia-eclampsia with the syndrome of hemolysis, elevated liver enzymes, and low platelet count: how rapid is postpartum recovery? Obstet Gynecol. 1990 Nov;76(5 Pt 1):737-41. doi: 10.1097/00006250-199011000-00001.
citation: Martin JN Jr, Blake PG, Perry KG Jr, McCaul JF, Hess LW, Martin RW. The natural history of HELLP syndrome: patterns of disease progression and regression. Am J Obstet Gynecol. 1991 Jun;164(6 Pt 1):1500-9; discussion 1509-13. doi: 10.1016/0002-9378(91)91429-z.
Clinical trial NCT04612660: HPV Self-test to Increase Cervical Cancer Screening in Asian Women
Official title: Human Papillomavirus (HPV) and Cervical Cancer Intervention to Increase Cervical Cancer Screening for Underserved Asian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 156
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study was to pilot test the feability of using HPV self-sampling testing to increase cervical cancer screening among under-served Asian women through engaging community-based organizations in the greater Philadelphia and New York City area, addressing a significant global cancer burden, the preventable infection-related cervical cancer.


Eligibility criteria: Inclusion Criteria:

1. gender: female
2. age: 30-55
3. no current diagnosis of cervical cancer, and
4. have not participated in cervical cancer screening within the past 3 years.

Exclusion Criteria:

-

Primary outcomes:
measure: the change in the rate of cervical cancer screening
timeFrame: baseline, and 6-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Asian Health, Lewis Katz School of Medicine, Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Grace Ma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma GX, Zhu L, Zhai S, Lin TR, Tan Y, Johnson C, Fang CY, Belinson JL, Wang MQ. Empowering Low-Income Asian American Women to Conduct Human Papillomavirus Self-Sampling Test: A Community-Engaged and Culturally Tailored Intervention. Cancer Control. 2022 Jan-Dec;29:10732748221076813. doi: 10.1177/10732748221076813.
Clinical trial NCT06457360: Comparison of Chitosan, Ankaferd and Tranexamic Acid in Dental Extraction in Liver Pre-Transplant Children
Official title: Comparative Assessment of Chitosan-Based Dressing, Ankaferd and Tranexamic Acid in Achieving Hemostasis and Healing Following Dental Extraction in Liver Pre-Transplant Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Liver Cirrhosis
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 39
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present study is:

To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases where the:

• Primary objective: is to evaluate which of the previous materials will be the most effective as a hemostatic agent


Eligibility criteria: Inclusion Criteria:

1. Patients with end stage liver disease that need dental extraction before liver transplant
2. Patients aged between 4 and 9 years old
3. Patients having international normalized ratio (INR) values ≤ 4 (i.e. 1-4)

Exclusion Criteria:

1. Patients with allergy to sea food because chitosan- based dressing is manufactured from freeze-dried chitosan, derived from shrimp shell.
2. Patients having genetic bleeding disorders
3. Patients with renal diseases

Primary outcomes:
measure: To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases
timeFrame: 30 minutes
Secondary outcomes:
measure: pain score assessment
timeFrame: 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: British University in Egypt
Study officials:
affiliation: British University In Egypt
name: noha S Kabil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912860: Immunogenicity and Safety Study of Serum-Free Avonex
Official title: A Multicenter, Open-Label Immunogenicity and Safety Study of a Serum-Free Pre-Formulated Solution of AVONEX (Interferon Beta-1a) Administered Intramuscularly to Patients With Relapsing/Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
interferon beta-1a
avonex
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the immunogenicity of a serum-free pre-formulated solution of Avonex when given to interferon beta naive patients with relapsing/remitting multiple sclerosis.


Eligibility criteria: Inclusion Criteria:

* Must have a diagnosis of relapsing/remitting MS as defined by McDonald, et al15; criteria numbers 1-4.
* Must have an expanded disability status scale (EDSS) score between 0 and 5.5, inclusive.
* Must be able to understand and comply with the protocol.

Exclusion Criteria:

* Has experienced a relapse within 2 months prior to Day 1. Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 48 hours, and accompanied by new objective neurological findings upon examination by the investigator.
* History of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that would preclude therapy with interferon beta.
* Abnormal screening or baseline blood tests determined to be clinically significant by the investigator
* History of a seizure within 3 months prior to Day 1.
* History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1.
* Known allergy to natural rubber latex.

Other inclusion and exclusion criteria apply as per protocol

Primary outcomes:
measure: To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX®
timeFrame: Study duration is 20 months
Secondary outcomes:
measure: To evaluate the safety of a serum-free pre-formulated solution of AVONEX®
timeFrame: The study duration is 20 months
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Biogen-Idec Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01347060: Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
Official title: Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
treatment
Advair and inhaled corticosteroids
Medicare
Outcomes
costs
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-05-04
Enrollment: 17448
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medicare-eligible subjects age 65 years and older with a diagnosis of asthma being treated with an inhaled corticosteroid

Brief summary: The objective of this study is to compare healthcare utilization and costs in Medicare-eligible asthma patients (aged \>65) who receive fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids in a typical clinical practice using a retrospective observational cohort study design of large managed care database. Outcomes on interest include asthma related severe exacerbations defined as asthma related emergency department visits, hospitalizations or combined emergency department/hospitalization. Other outcomes of interest include use of albuterol, oral corticosteroids and overall asthma related costs. Outcomes of interest will be compared between the two treatment cohorts (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids). Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox regression hazards analysis assessing time to first event for each asthma related endpoint adjusting for differences in baseline demographics such as age, gender, previous asthma medication use, co morbidities, costs, and plan demographics. Total asthma related costs will also be compared using generalized linear models adjusting for baseline differences.


Eligibility criteria: Inclusion Criteria:

* Subjects with asthma as determined by ICD-9 codes and asthma drug use
* at least 65 years of age
* prescription for an inhaled corticosteroid

Exclusion Criteria:

* a diagnosis of chronic obstructive pulmonary disease or
* a prescription for a chronic obstructive pulmonary disease treatment

Primary outcomes:
measure: Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
timeFrame: Up to 7 years from July 1, 2001 to June 30, 2008
Secondary outcomes:
measure: Mean Asthma-related Costs in the Post-index Period
timeFrame: Up to 7 years from July 1, 2001 to June 30, 2008
measure: Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant
timeFrame: Up to 7 years from July 1, 2001 to June 30, 2008
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: