louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02992002: Influence of Fluid Challenge on End-Expiratory Lung Impedance in Mechanically Ventilated Patients Monitored With Electrical Impedance Tomography
Official title: Influence of Fluid Challenge on End-Expiratory Lung Impedance in Mechanically Ventilated Patients Monitored With Electrical Impedance Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Circulatory Failure
Fluid Responsiveness
Fluid Overload
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 25
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: Mixed population of intensive care unit patients

Brief summary: The study investigates the influence of a clinically indicated fluid challenge on end-expiratory lung impedance, assessed by electrical impedance tomography (EIT). EIT data will be collected before, during and after infusion of 500 ml of crystalloid solution in mechanically ventilated patients on an operative intensive care unit.


Eligibility criteria: Inclusion Criteria:

* patients on mechanical ventilation
* clincial decision to monitor regional ventilation with electrical impedance tomography
* clinical indication for fluid challenge
* established cardiac output monitoring with transpulmonary thermodilution

Exclusion Criteria:

* age \< 18 years
* open lung injuries
* instable injury of spine or cranium
* thoracic metal implants
* body mass index \> 35

Primary outcomes:
measure: Change in end-expiratory lung impedance (EELI)
timeFrame: 15-30 minutes
Secondary outcomes:
measure: Correlation between change in end-expiratory lung impedance and change in intrathoracic blood volume
timeFrame: 15-30 minutes
measure: Fluid responsiveness
timeFrame: 15-30 minutes
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Medical Center Schleswig Holstein, Campus Kiel
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT00150202: Clinical Study Of EYE001 For Wet-Type AMD (Age-Related Macular Degeneration)
Official title: Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients with wet-type AMD, in order to establish that there is no large difference in the efficacy and the safety of the drug between Western and Japanese patients.


Eligibility criteria: Inclusion Criteria:

* Wet AMD, Visual Acuity from 20/320 to 20/40

Exclusion Criteria:

* Diabetic retinopathy, laser coagulation history

Primary outcomes:
measure: Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies.
Secondary outcomes:
measure: Safety profile of pegaptanib including side effects and lab test from the baseline to 54 weeks after the first treatment. Blood concentration of the drug from the baseline to 54 weeks after the irst treatment.
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Urayasu-shi
country: Japan
facility: Pfizer Investigational Site
state: Chiba-ken
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
state: Chiyoda-ku
city: Fukuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Maebashi
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Kida-gun
country: Japan
facility: Pfizer Investigational Site
state: Kagawa
city: Moriguchi
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Suita
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Otsu
country: Japan
facility: Pfizer Investigational Site
state: Shiga
city: Mitaka
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Fukushima
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01013402: Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia
Official title: Phase IV Study to Compare the Accuracy and Precission of Five Different Home Glucose Monitors;Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypoglycemia
Keywords: Hypoglycemia
Home Blood Glucose Monitoring
Subjects are being investigated for the integrity of
pituitary-adrenal functions by insulin hypoglycemia test.
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the accuracies and the capillary and venous comparabilities of five different home glucose monitors; Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart in an adult population.


Eligibility criteria: Inclusion Criteria:

* Being under investigation for pituitary- adrenal functions

Exclusion Criteria:

* Diabetes mellitus or any other chronic metabolic disease
* Taking medicine for any reason
* Anemia
* Polyctemia
* Compromised circulation
* Hypoxia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Department of Endocrinology and Metabolism
Study officials:
References:
citation: Trajanoski Z, Brunner GA, Gfrerer RJ, Wach P, Pieber TR. Accuracy of home blood glucose meters during hypoglycemia. Diabetes Care. 1996 Dec;19(12):1412-5. doi: 10.2337/diacare.19.12.1412.
citation: Funk DL, Chan L, Lutz N, Verdile VP. Comparison of capillary and venous glucose measurements in healthy volunteers. Prehosp Emerg Care. 2001 Jul-Sep;5(3):275-7. doi: 10.1080/10903120190939788.
citation: Clinical and Laboratory Standards Institute: Point-of-Care Glucose Testing in Acute and Chronic Care Facilities: Approved Guideline, 2nd ed. CLSI Document C30-A2. Wayne,PA: Clinical and Laboratory Standards Institute, 2002
citation: Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987 Sep-Oct;10(5):622-8. doi: 10.2337/diacare.10.5.622.
Clinical trial NCT00441402: Exercise Amenorrhea Stress and Bone Health in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2007-02-28
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: This study investigates the role of energy balance and stress in the regulation of hypothalamic-pituitary-gonadal axis in adolescent girls across the fitness spectrum.


Eligibility criteria: Inclusion Criteria:

* healthy adolescent girls not taking any medications

Exclusion Criteria:

* Hormonal preparation or birth control within 12 months prior to enrollment
* Galactorrhea
* Clinical Depression

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Josephine Z. Kasa-Vubu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasa-Vubu JZ, Rosenthal A, Murdock EG, Welch KB. Impact of fatness, fitness, and ethnicity on the relationship of nocturnal ghrelin to 24-hour luteinizing hormone concentrations in adolescent girls. J Clin Endocrinol Metab. 2007 Aug;92(8):3246-52. doi: 10.1210/jc.2006-2852. Epub 2007 May 15.
Clinical trial NCT00260221: VRH Pain Reduction During Burn Wound Care and Physical Therapy
Official title: Testing Interactions to Adjunctive Pain Control Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn
Keywords: Virtual Reality Hypnosis
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-12-01
Enrollment: 77
Sex: ALL
Minimum age (years): 7
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using Virtual Reality Hypnosis to relief pain and anxiety for burn patients.

Detailed description: The purpose of the study is to examine whether there is more effective relief of pain and anxiety during wound care procedures in burn-injured patients that are treated with Virtual Reality Hypnosis with post-hypnotic suggestion.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 7 years
* Able to complete subjective evaluations of pain
* English-speaking
* Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder
* Able to communicate orally

Exclusion Criteria:

* Age less than 7 years
* Incapable of indicating subjective evaluation of pain
* Non-English-speaking
* Demonstrating delirium, psychosis, or Organic Brain Disorder
* Unable to communicate verbally
* Significant developmental disability
* Extreme susceptibility to motion sickness

Primary outcomes:
measure: we use GRS, VAS, McGill,and nurse GRS to measure the pain.
timeFrame: once a day
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington; Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: David R. Patterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patterson DR, Tininenko JR, Schmidt AE, Sharar SR. Virtual reality hypnosis: a case report. Int J Clin Exp Hypn. 2004 Jan;52(1):27-38. doi: 10.1076/iceh.52.1.27.23925.
Clinical trial NCT01850121: Remicade in the Treatment of Patients With Active Ankylosing Spondylitis
Official title: Remicade in the Treatment of Patients With Active Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
infiximab
single armed trial
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active ankylosing spondylitis with BASDAI\>4

Brief summary: The aim of the study was to evaluate the efficacy of infliximab (IFX) treatment, 5 mg/kg every 6 weeks, in patients with active ankylosing spondylitis (AS) and to determine whether IFX dose reduction and interval extension, 3 mg/kg every 8 weeks during the second year sustained the treatment effect. The study was started in 2003 an finished in 2008.


Eligibility criteria: Inclusion Criteria:

The patients had to fulfill the following four inclusion criteria:

(I) Age between 18 and 60 years, (II) proven diagnosis according to the modified New York criteria 12 for definitive AS, (III) active disease with Bath AS Disease Activity Index (BASDAI) score above 4 and (IV) current or previous treatment with conventional non-steroidal anti-inflammatory drugs (NSAID) in adequate doses without sufficient effect.

Exclusion Criteria:

* current signs or symptoms of severe, progressive or uncontrolled hepatic, hematological, pulmonary, cardiac, neurological or cerebral disease;
* ongoing or past serious infection (including HIV and past or current tuberculosis);
* pregnancy or breast feeding;
* current malignancy or history of malignancy within the past five years;
* congestive heart failure and any contraindication to MRI.

Primary outcomes:
measure: Bath AS disease activity score (BASDAI)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Boel Morck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morck B, Pullerits R, Geijer M, Bremell T, Forsblad-d'Elia H. Infliximab dose reduction sustains the clinical treatment effect in active HLAB27 positive ankylosing spondylitis: a two-year pilot study. Mediators Inflamm. 2013;2013:289845. doi: 10.1155/2013/289845. Epub 2013 Sep 5.
Clinical trial NCT02485821: Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol
Official title: Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Failed Induction of Labor
Keywords: Estradiol
Misoprostol
Induction of labor
Cervical ripening
Bishop score
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor induction.

Detailed description: A prospective double blind randomized clinical trial. Conducted at Ain Shams University Maternity Hospital. Patients fulfilling inclusion and exclusion criteria will be divided into two groups. Group (A):

100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.

Group (B):

100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.

Primary Outcome

* Measure the time to cervical ripening. Secondary Outcome
* Measure the time to active labor.
* Number of misoprostol doses.
* Induction delivery time.
* Time to achieve vaginal delivery.
* Fetal outcome (Apgar score).

Eligibility criteria: Inclusion criteria:

* Maternal age ≥ 18 years old.
* Gestational age ≥ 37 wks to 41 wks.
* BMI between 20 kg/m2 and 35kg/m2.
* Vertex presentation.
* Singleton pregnancy.

Exclusion criteria:

* Multiple pregnancy.
* Non vertex presentation.
* Absolute or relative contraindication to vaginal delivery e.g. (Placenta previa, fibroid uterus, uterine anomalies, previous uterine surgery).
* PROM.
* IUFD.
* Fetal distress.

Primary outcomes:
measure: Time to cervical ripening.
timeFrame: 24 hours
Secondary outcomes:
measure: Time to active labor
timeFrame: 30 hours
measure: Number of misoprostol doses
timeFrame: 24 hours
measure: Induction delivery time
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: AinShams University
name: Osama El-Kady, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AinShams University
name: AbdEl-Latif El-Kholy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05313321: Survival of the Insignia Stem in Total Hip Arthroplasty
Official title: Mid-term Survival of the Insignia Stem in Primary Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Total Hip Arthroplasty
Keywords: Primary Total Hip Arthroplasty
Insignia™ Hip Stem
Radiographic review
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planning on undergoing primary total hip arthroplasty

Brief summary: The investigators primary objective of this study is to evaluate radiographic fit and fill of the Insignia stem and identify risk factors for aseptic failure. The investigators hypotheses being tested is: the newly designed Insignia stem demonstrates acceptable radiographic fit and fill by reviewing radiolucent lines \<2mm.

Detailed description: Total hip arthroplasty is one of the most functionally restorative procedures in modern medicine. Since its introduction in the mid twentieth century significant advancements in implant materials have occurred. There is debate on the design of the femoral stem in total hip arthroplasty. The use of uncemented, Hydroxyapatite (HA)-coated femoral stems have been shown to be reliable and are commonly used. One such implant is the Insignia™ Hip Stem (Stryker, Kalamazoo, MI, USA).

The Insignia™ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside. Unfortunately, with it's novelty comes a lack of clinical follow-up and evaluation. As such, the investigators purpose of this study is to evaluate the early radiographic of the Insignia™ Hip Stem.

Eligibility criteria: Inclusion Criteria:

* Patients age ≥18
* Patients planning on undergoing primary total hip arthroplasty that will likely receive the Insignia stem and associated Stryker Acetabular Component.
* Preoperative diagnosis of osteoarthritis
* Patients willing and able to comply with follow-up requirements
* Patients willing to sign an IRB approved consent and authorization document

Exclusion Criteria:

* Patients with inflammatory or pyogenic arthritis
* Body Mass Index (BMI)\>40
* Bone stock that is inadequate for support or fixation of the prosthesis

Primary outcomes:
measure: Radiographs review
timeFrame: Pre-operative
measure: Radiographs review
timeFrame: 6-weeks post-operative
measure: Radiographs review
timeFrame: 1-year post-operative
measure: Radiographs review
timeFrame: 2-years post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: University of Utah Orthopaedics
name: Lucas Anderson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00234221: Project Health Link: Connecting Patients With Services
Official title: Services Interventions for Injured ED Problem Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2005-10-06
Enrollment: 686
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will compare three alternative interventions in the emergency department (ED) to promote substance abuse assessment, referral, and treatment entry: 1) a 5 session strengths-based case management model (SBCM); 2) a 2-session motivational enhancement therapy (MET); or 3) a one-time brief informational feedback (BIF) session. The primary outcome variables for this trial include follow-through on receiving an assessment and referral, and treatment engagement. Additional outcomes include degree of treatment completion, alcohol-related measures, health service utilization, health status changes, and psychosocial factors.


Eligibility criteria: Inclusion Criteria:

* (1) adults age 19 - 60 presenting to the Emergency Department at Hurley Medical Center within 24 hours of an injury; (2) ability to provide informed consent.

For intervention portion of the project: (1) meets DSM-IV criteria for alcohol abuse or dependence in the following year. (Patients who meet abuse/dependence criteria for alcohol may also be using other drugs. They will be included in the study only if they do not meet criteria for past year drug abuse/dependence).

Exclusion Criteria:

* (1) adult patients who do not understand English; (2) prisoners; (3) pregnant women; (4) institutionalized patients (e.g. nursing home residents); (5) adults classified by medical staff as "Level 1 trauma"; (6) adults deemed unable to provide informed consent (e.g. intoxication, mental incompetence, under guardianship); (7) patients treated in the ED for suicide attempts and sexual assault; (8) patients meeting past year drug abuse/dependence criteria; and (9) patients who have been in treatment for alcohol or other drug abuse/dependence in the previous year.

Primary outcomes:
measure: receipt of assessment
timeFrame: 3 and 6 months post-baseline
measure: treatment entry
timeFrame: 3 and 6 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Frederic C Blow, PhD
role: PRINCIPAL_INVESTIGATOR
References: