louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04443101: Effective Lens Position After Cataract Surgery
Official title: Comparison of Changes in Effective Lens Position of Different Types of Intraocular Lens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-related Cataract
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Diagnosed as cataract in our hospital;
* Implanted intraocular lens: SN6CWS, Aspira-aA, MI60;
* Cataract phacoemulsification and intraocular lens implantation.

Brief summary: Cataract patients were implanted with different types of intraocular lenses for grouping. SSOCT scanning was used to measure ELP and optometry.

Detailed description: Cataract patients were implanted with different types of intraocular lenses for grouping. Perform SSOCT scan that was used to measure effective lens position and optometry at different postoperative follow-up time .

Eligibility criteria: Inclusion Criteria:

* a.Diagnosed as cataract;
* b.Implanted intraocular lens: SN6CWS, Aspira-aA, MI60;
* c.Cataract phacoemulsification and intraocular lens implantation.

Exclusion Criteria:

* a.Combined with corneal opacity, glaucoma, uveitis, retinal detachment and other eye diseases;
* b.A history of intraocular surgery or trauma other than cataract surgery;
* c.Intraoperative complications such as tearing of the capsule and IOL failure to implant;
* d.Endophthalmitis, corneal endothelial decompensation and other postoperative complications;
* e.Those with incomplete data collected during the follow-up period of postoperative patients.

Primary outcomes:
measure: effective lens position
timeFrame: up to 3 months after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Ophthalmology and Optometry Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT00413101: A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.
Official title: An Open-Label Study to Investigate Improvement in Heart Function After Complete Anemia Correction With NeoRecormon in Patients With End-Stage Renal Disease Already Receiving Sub-Optimal Doses of NeoRecormon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level \<105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* end-stage renal disease;
* on renal dialysis \>= 3 months;
* receiving NeoRecormon treatment \>= 3 months;
* Hb stable and \<105g/L, and LVMI \>160g/m2.

Exclusion Criteria:

* unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
* use of any ESA other than NeoRecormon;
* acute infection;
* use of iv NeoRecormon.

Primary outcomes:
measure: Hb level, BP.
timeFrame: Throughout study
measure: LVMI ejection fraction, ejection fraction.
timeFrame: 12 months
Secondary outcomes:
measure: SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01922401: Inverse Ratio Ventilation on Bariatric Operation
Official title: Effects of a Changes in Inspiratory to Expiratory Ratio on Respiratory Mechanics and Oxygenation During Laparosopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: for evaluating inverse ratio ventilation of laparoscopic bariatric surgery

Detailed description: inverse ratio ventilation had been improve the oxygenation and respiratory mechanics during care of ARDS patients or during general anesthesia. We hypothized inverse ratio ventilatio could improve the oxygenation and respiratory mechanics on the obese patient also.

Eligibility criteria: Inclusion Criteria:

* ASA PS 1-2 obese patients(BMI\>30)

Exclusion Criteria:

* underlying cardiopulmonary diasease

Primary outcomes:
measure: Arterial oxygenation (PaO2)
timeFrame: baseline PaO2-2hour after pneumoperitoneum
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon Universiy Gil Medical Center
name: Kyung Cheon Lee, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02705001: Nurse Graduateness and Patient Outcomes: a Cross Sectional Pilot Study
Official title: Nurse Graduateness and Patient Outcomes: a Cross Sectional Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: no Spedific Condition, All-cause In-patient Mortality
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Weill Cornell Medical College in Qatar
name: University of Hull
name: Australian Catholic University
name: University of South Australia
First posted: 2016-03-10
Enrollment: 1252
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that visited the 7 participating hospitals

Brief summary: This research project is relevant to the identification of the relationship, and its significance, between patient morality and a number of demographic, clinical and corporate characteristics. Two separate data sets have been compiled linking the existing intervention and employment data, one focusing on the admitting nurse and another one considering all the nurses involved in each intervention. Several statistical experiments will take place to support or reject the main hypothesis: higher nurse education, satisfaction and staffing levels result to lower patient mortality.

Detailed description: The primary research objective is to investigate the relationship between the education, satisfaction and staffing level of the nurses and the mortality rate across HMC. The relationship between mortality will be investigated against some additional demographic characteristics of the patient and the nurses as well as a umber of clinical parameters like the length of stay and the severity of the interventions. To achieve that data will be retrospectively collected from the Human Resources database containing the nurse education and demographic information and will combine it to the intervention data coming from the clinical information systems of all major public hospitals in Qatar excluding accident and emergency cases to avoid confounding. Rigorous statistical analysis will be conducted to obtain the significance of this relationship within expected confidence intervals. The end result of that process is to find whether there is a significant positive or negative relationship between nurse education and mortality rate.

For confounding purposes Accident and Emergency data have been excluded, we have performed several adjusted and unadjusted Logistic Regression tests and taking into consideration the clustering effect of the data.

Eligibility criteria: Exclusion Criteria:

* Accident and emergency patients
* Records with negative length of stay
* Records with incorrect patient demographics

Primary outcomes:
measure: All-cause In-Patient Mortality
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03609801: The Duluth Model and ACTV for Domestic Violence
Official title: A Randomized Trial of the Duluth Model and ACTV for Domestic Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Domestic Violence
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 799
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to compare the effectiveness of two interventions for intimate partner violence (IPV). In most states, men who are convicted of domestic assault court-mandated to complete a Batterers Intervention Program (BIP) as part of their sentencing. The most commonly used BIP is based on The Duluth Model, which has been shown to decrease the recidivism of IPV offenders, but only marginally. The Duluth Model is a group intervention based on feminist theory and cognitive behavioral therapy. A new BIP called Achieving Change Through Values-Based Behavior (ACTV) has recently been developed by the PI as an alternative to Duluth. ACTV is currently being used statewide within the Department of Corrections (DOC) in Iowa. ACTV is a group intervention that utilizes acceptance and mindfulness techniques in addition to techniques from cognitive behavior therapy. The current study will use a randomized control trial to compare Duluth and ACTV, in order to assess the interventions' relative impact reducing IPV behaviors (physical aggression, psychological aggression, stalking, harassment, etc). Data on these outcomes will be collected via official criminal justice reports (i.e., criminal charges) as well as reports from victims. Other processes and outcomes of interest (attitudes toward women, emotion regulation, parenting behaviors, etc) will be collected from offenders.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* First time domestic assault offender
* Domestic assault must be against an intimate partner
* Must be on supervision/probation

Exclusion Criteria:

* Participation in any previous ACT-based or Duluth Model programming

Primary outcomes:
measure: Domestic assault recidivism
timeFrame: One year time period following BIP
measure: Conflict Tactics Scale
timeFrame: Start and end of BIP, then one year later
Secondary outcomes:
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Start and end of BIP
measure: Male Role Norms Inventory-Revised
timeFrame: Start and end of BIP
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: 5th Judicial District Department of Corrections
state: Iowa
Study officials:
affiliation: Iowa State University
name: Amie Zarling, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zarling A, Russell D. A randomized clinical trial of acceptance and commitment therapy and the Duluth Model classes for men court-mandated to a domestic violence program. J Consult Clin Psychol. 2022 Apr;90(4):326-338. doi: 10.1037/ccp0000722.
Clinical trial NCT02816801: The Butler-Program 2.0: An Internet Platform for Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, effectiveness of an internet based intervention (Butler 2.0) for elderly is tested. Participants (n= 60) will be randomly assigned to two different groups (intervention vs. waitlist). Outcomes in terms of loneliness and quality of life will be assessed at pre-, post (6 weeks) and follow-up (3 months).

Detailed description: Elderly people (age 65+ ) in Zurich will have access to the Butler program 2.0. Butler 2.0 has been designed for elderly with little experience in the use of computers. Several means of communication such as e-mail, video conferencing, chat and a blog are united on this platform. Furthermore, relaxation exercises are offered in the form of virtual walks.

Eligibility criteria: Inclusion Criteria:

* age: 65 years or older
* comprehension of German language
* access to Internet

Exclusion Criteria:

* suicidality
* poor eyesight which makes use of intervention impossible

Primary outcomes:
measure: World Health Organization Quality of Life (WHOQL)-BREF
timeFrame: 3 months
Secondary outcomes:
measure: Geriatric Depression Scale
timeFrame: 3 months
measure: State-Scale of the State-Trait Anxiety Inventory (STAI-S)
timeFrame: 3 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
References:
Clinical trial NCT01603901: Regulated Negative Pressure-Assisted Wound Therapy Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Negative-Pressure Wound Therapy
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-05-23
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Regulated negative pressure-assisted wound therapy (RNPT) is regarded as a gold standard technology for treatment of various chronic and acute wounds. The investigators plan to evaluate the efficacy and ease of use of this device.


Eligibility criteria: Inclusion Criteria:

* Chronic or acute wounds

Exclusion Criteria:

* Uncontrolled bleeding
* Neoplasms in wound
* Exposed blood vessels
* Exposed internal organs

Primary outcomes:
measure: Efficacy
timeFrame: Ten days
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT02287701: Exploratory Investigation of Advanced PET/MRI Metrics for Bladder Cancer Characterization
Official title: Exploratory Investigation of Advanced PET/MRI Metrics for Bladder Cancer Characterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: bladder cancer
MRI
PET
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Society of Abdominal Radiology
First posted: 2014-11-11
Enrollment: 24
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 overarching goal of this project is to explore whether associations exist between metrics obtained from PET/MRI incorporating advanced MRI sequences and features of bladder cancer, including grade, stage, and treatment response.

Detailed description: The investigators will assess an advanced non-Gaussian diffusion-weighted imaging (DWI) model termed diffusion kurtosis imaging, multi-echo T2 mapping, dynamic contrast-enhanced (DCE) MRI using a motion-robust high-temporal and high-resolution radial acquisition scheme employing compressed sensing, and simultaneously acquired 18-fluoro (18F)- fluorodeoxygluclose (FDG) data. Preliminary data demonstrates the investigators ability to execute and evaluate all of these techniques at the investigators center. The investigators hypothesize that these techniques will be sensitive to functional and metabolic differences between subsets of bladder cancer cases and will improve upon the performance of current imaging protocols in bladder cancer characterization. Moreover, the investigators believe that these techniques will provide complementary information, such that they may be combined in a synergistic fashion for bladder cancer evaluation.

Eligibility criteria: Inclusion Criteria:

* Histologic or imaging evidence of urothelial carcinoma of the bladder
* Age ≥ 18 years of age
* If female of childbearing potential, pregnancy test is negative. (In these instances, the patient will need to provide documentation of negative pregnancy test results.)

Exclusion Criteria:

* Inability to tolerate MRI including conditions such as claustrophobia or inability to lay flat for \> 45 minutes.
* Presence of pacemaker/implantable cardiac device (ICD) or perfusion pumps
* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants.
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study

Primary outcomes:
measure: Tumor standardized uptake value (SUV) from 18-fluorodeoxyglucose PET/MRI scan
timeFrame: within one week of study completion
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Andrew Rosenkrantz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02867501: Venous Distension in Patients With Aneurysmatic Arterial Disease
Official title: Venous Distension in Patients With Aneurysmatic Arterial Disease Compared to the Venous Distension in Patients With Arterial Occlusive Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Popliteal Artery Aneurysm
Peripheral Arterial Occlusive Disease
Vascular Diseases
Aortic Diseases
Varicose Veins
Keywords: venous distension
venous reflux
Lead sponsor: Kantonsspital Baselland Bruderholz
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is selected from patients of the angiologic clinic Baselland Bruderholz

Brief summary: The aim of the study is to assess if venous distension in patients with aneurysmatic arteriopathy is higher compared to patients with peripheral arterial occlusive disease (PAOD) and in controls.

Detailed description: Patients with aortic aneurysm and patients with PAOD and Controls will be investigated in the following manner: Duplexsonography with assessment of the arterial diameters in the aorta and leg arteries. Duplexsonography with assessment of venous reflux in proximal and deep veins of both legs Duplexsonography testing of venous distension in the common femoral vein, the great saphenous vein and the femoral vein.

Eligibility criteria: Inclusion Criteria:

* Patients with dilatative arteriopathy (DA) the aortic diameter must be \> 3 cm or the popliteal artery diameter \> 1.5 cm
* Patients with arterial occlusive disease (PAOD) defined with an Ankle brachial index (ABI) \< 0.9 and positive criteria in the Edinburgh questionnaire
* Patients able to give informed consent
* Control group of age matched persons without PAOD (ABI \> 0.9) and without DA

Exclusion Criteria:

* Impossibility to stand
* Diabetes
* No given informed consent
* Persons and patients \< 18 years old
* Acute deep venous thrombosis
* History of deep venous thrombosis

Primary outcomes:
measure: Venous distension of > 27% in patients with aneurysmatic arterial disease
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Jeanneret C, Baldi T, Hailemariam S, Koella C, Gewaltig J, Biedermann BC. Selective loss of extracellular matrix proteins is linked to biophysical properties of varicose veins assessed by ultrasonography. Br J Surg. 2007 Apr;94(4):449-56. doi: 10.1002/bjs.5630.
citation: Jeanneret C, Jager KA, Zaugg CE, Hoffmann U. Venous reflux and venous distensibility in varicose and healthy veins. Eur J Vasc Endovasc Surg. 2007 Aug;34(2):236-42. doi: 10.1016/j.ejvs.2007.03.018. Epub 2007 May 24.
Clinical trial NCT03699501: Psychometric Validation of an Oral Health-related Scale for Quality of Life and Coping in People With Schizophrenia
Official title: Psychometric Validation of an Oral Health-related Scale for Quality of Life and Coping in People With Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 108
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: Managed in a Specialised Institution (University Hospital, Psychiatric hospital or Hospital), either in full hospitalisation or on an outpatient basis

Brief summary: Schizophrenia is a severe and persistent psychological disorder affecting 0.7 to 1% of the world's population and 600,000 people in France. Schizophrenic patients are exposed to excess mortality and a life expectancy that is 10 to 15 years lower than the general population (excluding causes of suicide) and to numerous co-morbidities, including oral diseases.

To improve this public health problem, concrete action must be undertaken and evaluated in both quantitative and qualitative terms. While there are many quantitative indicators, there are no reliable and valid tools for the perceived oral health of these individuals in the context of their real and/or imagined world.

The results of a qualitative study previously carried out by our team (QUALITY Study: NCT02730832) made it possible to develop two hypothetical questionnaires for evaluating quality of life related to oral health, the Schizophrenia Oral Health Profile (SOHP), and a questionnaire for evaluating coping strategies with regard to oral health, the Schizophrenia Coping Oral Health Profile (SCOOHP).

However, before these questionnaires can be used in clinical practice, their psychometric properties must be validated.


Eligibility criteria: Inclusion Criteria:

* Adult person,
* Patients for whom a diagnosis of schizophrenia is defined according to ICD 10
* Person who has given his or her oral agreement to participate in the study, with the agreement of the tutor in the context of a tutorship,
* Managed in a Specialised Institution (University Hospital, Psychiatric hospital or Hospital), either in full hospitalisation or on an outpatient basis,
* Fluent use of the French language.

Exclusion Criteria:

* Psychiatrically unstable and delusional patients.
* Patients with cognitive abilities too impaired to participate in the study
* Individuals with no natural teeth
* Pregnant or breastfeeding women
* Patients not affiliated to the national health insurance system.

Primary outcomes:
measure: reliability of scales (internal consistency)
timeFrame: through study completion, an average of 18 months
measure: validity of scales (consistency of responses)
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References: