louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05290870: Registry Study on Intraocular Lenses Manufactured by Teleon Surgical B.V.
Official title: Registry Study on Hydrophilic (HydroSmart) and Hydrophobic (ACUNEX) Intraocular Lenses Manufactured by Teleon Surgical B.V.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aphakia
Cataract
Clear Lens Exchange
Refractive Lens Exchange
Keywords: Pseudoaphakia
Lead sponsor: Teleon Surgical B.V.
Sponsor class: INDUSTRY
Collaborators: name: MaganaMed GmbH
First posted: 2022-03-22
Enrollment: 2183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone uni- or bilateral extraction of the crystalline lens by means of phacoemulsification or femtosecond laser-assisted cataract surgery with implantation of the subject IOL.

Brief summary: This is a retrospective, observational (Registry) study aiming to collect safety and performance data on the use of intraocular lenses (IOLs) manufactured by Teleon Surgical B.V. according to routine practice.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Diagnosis of cataract in at least one eye or seeking clear/refractive lens exchange
* Provide consent to retrospective data collection

Exclusion Criteria:

* Patients younger than 18 years
* Patients with congenital primary aphakia or secondary aphakia

Primary outcomes:
measure: Visual acuity (uncorrected and/or corrected)
timeFrame: Preoperatively to Month 24
Secondary outcomes:
measure: Adverse events and adverse device effects
timeFrame: Usual follow-up: 24 Months
measure: Patient and user satisfaction
timeFrame: Month 1
Other outcomes:
Locations:
city: Spankeren
country: Netherlands
facility: Teleon Surgical B.V.
state: AV
Study officials:
References:
Clinical trial NCT03769870: Teneligliptin and Atorvastatin DDI Study
Official title: A Randomized, Open-label, Cross-over, Multiple Dosing Study to Evaluate Drug-drug Interaction Between Teneligliptin and Atorvastatin in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabete Mellitus
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-10
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between Teneligliptin and Atorvastatin in healthy male adults


Eligibility criteria: Inclusion Criteria:

1. Healthy male adult 19 to 45 years
2. Body weight ≥ 50kg, and BMI between 18-29kg/m2 at screening
3. Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.
4. Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.

Primary outcomes:
measure: Cmax,ss(Maximum concentration at steady state)
timeFrame: 24 hours
measure: AUCτ,ss(Area under the concentration-time curve at steady state)
timeFrame: 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea Universitiy Guro Hospital
Study officials:
References:
Clinical trial NCT00184470: Trauma Registration at St. Olavs Hospital 2000-2003
Official title: Mapping of Traumatized Patients Referred to St. Olavs Hospital in the Period 2000-2003-Norwegian University of Science and Technology
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Injuries, Multiple
Norway/Epidemiology
Trauma Centers/Statistics & Numerical Data
Trauma, Multiple
Trauma Severity Indices
Keywords: Adult
Child
Hospitalization/statistics & numerical data
Retrospective studies
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-09-16
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: St. Olavs Hospital is a trauma referral center in the region of Midtnorge. Admitting trauma patients locally and those referred from hospitals in Nord-Trøndelag, Sør-Trøndelag and Møre-Romsdal.An active trauma team was defined in 1992, but it's work has not been evaluated earlier. Prospective studies of these patients were established 1st of January 2004 at St. Olavs Hospital.

Detailed description: This mapping is a observational retrospective study of trauma patients admitted to St.Olavs Hospital from 2000 until 2003. Patient journals (electronic and paper), autopsy reports and the emergency medical respons systems (AMK) database have been reviwed. We are reviewing the local traumaepidemiology, traumateam performance, mechanisms of injury and the potenially avoidable deaths in trauma.

Eligibility criteria: Inclusion Criteria:

* Trauma team activation
* Motor vehicle crash with ejection
* Pedal cyclist, motorcyclist or pedestrian hit by vehicle \>30 km/h
* Fall \> 5 meters
* Fatality in same vehicle
* Interhospital trauma transfer within 24 hrs
* Injury to two or more body regions
* Fracture to two or more long bones
* Spinal cord injury
* Amputation of a limb
* Penetrating injury to head, neck, torso or proximal limb

Exclusion Criteria:

* Burns
* Strangulations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Eirik Skogvoll, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03481270: The Oakland Men's Health Disparities Study
Official title: The Oakland Men's Health Disparities Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Cardiovascular Risk Factor
Influenza
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 1374
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: OTHER

Brief summary: Reducing racial disparities in health outcomes is a major policy concern in the United States. Although there has been recent progress to close the gap, black men continue to experience earlier morbidity and mortality from preventable and manageable medical conditions, and live on average 4.2 years less than their white male peers. An oft-prescribed solution to close this stubborn gap is to increase the diversity of the healthcare workforce. Another common policy tool to increase take-up of preventative healthcare services is financial incentives. In this randomized evaluation, we will estimate the effects of financial incentives and a racially concordant physician on the uptake of preventive health services in Oakland, California.


Eligibility criteria: Inclusion Criteria:

* African American male adults

Exclusion Criteria:

-

Primary outcomes:
measure: Average Take-up of Preventive Services (Post-consultation)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Barbershops / Fleamarkets
state: California
Study officials:
References:
Clinical trial NCT00548470: Varenicline Effects In Schizophrenic Smokers
Official title: Evaluation of Varenicline's Clinical Efficacy for Continued Smoking Abstinence When Used in the Clinical Treatment of Schizophrenic Patients Hospitalized in an Institution With a Ban on Cigarette Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Tobacco Use Disorder
Nicotine Dependance
Keywords: schizophrenia
varenicline
cognition
cigarette smoking
Lead sponsor: Nathan Kline Institute for Psychiatric Research
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2007-10-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label pre-post study of the effects of clinical treatment with varenicline on 1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in schizophrenic patients, and 3) psychopathology in schizophrenic patients. Patients are assessed on subjective and objective measures of smoking, selected cognitive measures, and special chemical measures, during baseline testing and during 8 weeks of treatment with varenicline (1-2 mg/day).


Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis
* Recent History of Cigarette smoking
* Ages 18-65

Primary outcomes:
measure: Self Report of Smoking
timeFrame: Baseline and during 2 months of treatment
measure: CO (Carbon Monoxide) Breathalyzer Level
timeFrame: baseline and during 2 months of treatment
measure: Plasma Cotinine
timeFrame: baseline 1 month and 2 months
Secondary outcomes:
measure: RBANS Neuropsychological Battery
timeFrame: baseline and month 2 of treatment
measure: Change From Baseline in Psychiatric Symptoms
timeFrame: Baseline and 2 months later
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Psychiatric Center
state: New York
Study officials:
affiliation: Nathan Kline Institute of Psychiatric Research; NYU School of Medicine
name: Robert C Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith RC, Lindenmayer JP, Davis JM, Cornwell J, Noth K, Gupta S, Sershen H, Lajtha A. Cognitive and antismoking effects of varenicline in patients with schizophrenia or schizoaffective disorder. Schizophr Res. 2009 May;110(1-3):149-55. doi: 10.1016/j.schres.2009.02.001. Epub 2009 Feb 28.
Clinical trial NCT05760170: Determining Clinical Trial Experiences of Lung Cancer Patients
Official title: An Observational Study to Determine Experience Patterns in Participants of Lung Cancer Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Keywords: lung cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lung cancer patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will admit a wide range of data on the clinical trial experience of lung cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future lung cancer patients.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with lung cancer
* Patient has self-identified as planning to enroll in an observational clinical trial
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Pregnant or nursing patients
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Number of lung cancer patients who decide to enroll in a clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in a lung cancer clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Menis J, Besse B, Lacombe D. Methodology of clinical trials in lung cancer. Chin Clin Oncol. 2015 Dec;4(4):44. doi: 10.3978/j.issn.2304-3865.2015.11.03.
citation: Schulkes KJ, Nguyen C, van den Bos F, van Elden LJ, Hamaker ME. Selection of Patients in Ongoing Clinical Trials on Lung Cancer. Lung. 2016 Dec;194(6):967-974. doi: 10.1007/s00408-016-9943-7. Epub 2016 Sep 20.
citation: Schulkes KJ, Nguyen C, van den Bos F, Hamaker ME, van Elden LJ. Patient-Centered Outcome Measures in Lung Cancer Trials. Lung. 2016 Aug;194(4):647-52. doi: 10.1007/s00408-016-9903-2. Epub 2016 Jun 10.
Clinical trial NCT01246570: Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients
Official title: Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: exercise
heart
coronary disease
rehabilitation
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 48
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is known that organized cardiac rehabilitation is effective in improving exercise capacity in coronary heart disease patients. Less is known about the long-term results after cardiac rehabilitation. Earlier studies have shown that many patients quit exercising when no longer attending formal rehabilitation. The investigators wish to investigate the effect of a maintenance program after ending a rehabilitation program, and to compare this to usual care. The investigators hypothesis is that the maintenance program will result in higher exercise capacity and more physical activity compared to usual care.


Eligibility criteria: Inclusion Criteria:

* coronary heart disease patients

Exclusion Criteria:

* unstable angina pectoris
* hemodynamic significant valve disease (\> New York Heart Association class II)
* pregnancy
* left ventricular ejection fraction \<30%
* kidney failure (creatinin \> 140)
* uncontrolled hypertension

Primary outcomes:
measure: Peak oxygen uptake
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Myocardial infarction
timeFrame: baseline and 12 months
measure: Hospital readmission
timeFrame: baseline and 12 months
measure: Death
timeFrame: baseline and 12 months
measure: Endothelial function
timeFrame: baseline and 12 months
measure: Quality of life
timeFrame: baseline and 12 months
measure: Blood markers
timeFrame: baseline and 12 months
measure: Physical activity
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Trine Moholdt, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madssen E, Arbo I, Granoien I, Walderhaug L, Moholdt T. Peak oxygen uptake after cardiac rehabilitation: a randomized controlled trial of a 12-month maintenance program versus usual care. PLoS One. 2014 Sep 23;9(9):e107924. doi: 10.1371/journal.pone.0107924. eCollection 2014.
Clinical trial NCT02005770: Anesthesia and Circulating Tumor Cells in Breast Cancer
Official title: Does Anesthesia Technique Affect the Presence of Circulating Tumor Cells in Primary Breast Carcinoma? A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Female Breast Carcinoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 221
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Serious concern about the role of anesthesia in tumor recurrence has considerably risen over years, but the lack of surrogate markers for tumor spreading made trials addressing this issue difficult to realize. In breast cancer patients CTC positivity has been recently recognized as an independent prognostic factor. In this respect, we postulated that in a first step changes in the number of CTC after general anesthesia would help to determine the effect of anesthesia on this tumor marker.

Detailed description: Patients with primary breast cancer will be randomized to either propofol or sevoflurane anesthesia for curative surgery. CTC will be determined in the pre- as well as postoperative phase and the kinetic of CTC in the two groups will be compared.

Eligibility criteria: Inclusion criteria: \> Female

* Age 18 to 85
* ASA I-III
* Primary breast cancer (TNM stage = T1-3, N0-2, M0)
* Primary surgery
* Written informed consent

Exclusion criteria:

* Metastatic breast cancer
* Other than primary surgery (recurrence, reconstruction)
* Pre-operative chemotherapy or radiotherapy
* Auto-immune disease, HIV, other active cancer, age\>85, ASA IV or V
* Concomitant regional anesthesia
* Chronic opioids medication
* Any systemic immunosuppressive therapy
* Known hypersensitivity or suspected allergy to propofol, soya or egg proteins
* Known hypersensitivity to volatile anesthetics (malignant hyperthermia)
* Pregnancy
* Breast feeding
* Non German-speaking patients
* Enrollment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion

Primary outcomes:
measure: Number of CTC before and after administration of anesthetics
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institute of Anesthesiology
state: ZH
city: Zurich
country: Switzerland
facility: Institute of Physicians for Anesthesia and Intensive Care Klinik Hirslanden
Study officials:
affiliation: University Hospital Zurich, Institute of Anesthesiology
name: Beatrice Beck Schimmer, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hovaguimian F, Braun J, Z'graggen BR, Schlapfer M, Dumrese C, Ewald C, Dedes KJ, Fink D, Rolli U, Seeberger M, Tausch C, Papassotiropoulos B, Puhan MA, Beck-Schimmer B. Anesthesia and Circulating Tumor Cells in Primary Breast Cancer Patients: A Randomized Controlled Trial. Anesthesiology. 2020 Sep;133(3):548-558. doi: 10.1097/ALN.0000000000003409.
Clinical trial NCT01073670: Indomethacin and Cardiac Bypass Surgery
Official title: Quantification of Postoperative Coagulation Following Administration of Indomethacin to Expedite Fast-tracking of Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhage
Keywords: NSAIDs
bleeding
thromboelastography
cardiac surgery
Indomethacin
acetaminophen
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Following signed informed consent, patients scheduled for elective cardiac surgery were randomly assigned to one of 3 groups to be given acetaminophen, Indomethacin or a combination of both immediately following induction and then at 6, 12, 18 \& 24 hours following surgery. Our primary outcome measure was the amount of blood drained from the mediastinal tubes and chest drains. Secondary outcome measures included conventional blood coagulation indices as well as other measures of clotting as indicated by thromboelastography (TEG). Other secondary outcome measures included consumption of morphine equivalents and pain scores.


Eligibility criteria: Inclusion Criteria:

* scheduled to undergo either elective coronary artery bypass or single valve replacement
* normal platelet count
* normal prothrombin time
* normal partial thromboplastin time
* normal serum creatinine

Exclusion Criteria:

* sensitivity to study drugs
* history of bleeding diathesis
* renal dysfunction
* active peptic ulcer

Primary outcomes:
measure: amount of blood lost via chest drains during and following cardiac bypass surgery
timeFrame: during surgery and then until chest drains removed (< 24 hours)
Secondary outcomes:
measure: blood clotting indices (i.e., conventional and using thromboelastography)
timeFrame: perioperative period until 24 hours post-operative
measure: Morphine equivalents required to provide effective analgesia
timeFrame: perioperative period until 24 hours post-operative
measure: pain scores
timeFrame: perioperative period until 24 hours post-operative
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Joel L Parlow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00037570: Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
Official title: A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients With Bleeding Peptic Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peptic Ulcer Hemorrhage
Keywords: Peptic
Ulcer
Hemorrhage
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: This is a multicenter, randomized, double-blind, parallel-group, dose-ranging, comparator-controlled study of the effect of pantoprazole on intragastric pH after successful endoscopic hemostasis in hospitalized patients. Patients will receive either intravenous pantoprazole (one of two regimens) or ranitidine (the comparator) within 2 hours of successful hemostasis and administration will continue for 72 hours after hemostasis.


Eligibility criteria: Inclusion Criteria:

* Patients must be men or nonpregnant women at least 18 years of age
* Patients who present with a gastric or duodenal ulcer (major dimension of the ulcer must be ≥ 5 mm and ≤ 20 mm) with endoscopic appearance of spurting, oozing, or nonbleeding visible vessel (NBVV) Patients presenting with adherent protruding clot are eligible if, after removal of the clot by irrigation, the underlying lesion is classified as spurting, oozing or a NBVV. Patients with an actively bleeding ulcer or a NBVV within a hiatal hernia are eligible if the ulcer is located below the Z-line)

Exclusion Criteria:

* Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation
* Patients presenting with active bleeding and/or NBVV at 2 or more separate sites
* Patients with any severe concomitant diseases, eg, end-stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References: