louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01735435: Tight Caloric Balance in Geriatric Patients
Official title: Tight Caloric Balance in Geriatric Patients After Hip Fracture.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Assessment
Keywords: geriatric patients
nutritional support
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study to assess the impact of nutritional support guided by repeated measurements of REE in geriatric patients following surgery for hip fractures.

Our hypothesis is that tight caloric control will reduce the risk of significant postoperative complications in geriatric patients following surgery for hip fractures.

Study Design :Prospective, Single center, Randomized, Unblinded study. Study Population:geriatric patients following surgery for hip fractures.

Detailed description: The primary outcome:

presence of postoperative complications,hospital length of stay.

Secondary outcomes:

energy intake and calculated energy balance

Study Procedure:

eligible patients will be randomly assigned to 2 groups: the tight calorie (intervention)group and the control group.

Eligibility criteria: Inclusion Criteria:

patients older than 65 years who were admitted to the unit following hip fracture within 48 hours of the injury and in whom orthopedic surgery was considered the treatment of choice.

Exclusion Criteria:

Patients were excluded if they presented to hospital \> 48 hours after the injury, were receiving steroids and/or immunosuppression therapy; in the presence of active oncologic disease, multiple fractures, diagnosed dementia or in the event that patients required supplemental nasal oxygen which precludes the measurement of resting energy expenditure.

Primary outcomes:
measure: Rate of postoperative complications
timeFrame: up to day 14
Secondary outcomes:
measure: Energy balance
timeFrame: prior to surgery and up to 14 day
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: RabinMC
Study officials:
affiliation: RabinMC,Beilinson Hospital
name: Pierre Singer, Professor,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05648435: Lithium Clearance in Patients With High Risk of Acute Kidney Injury
Official title: Proximal Tubule Function in Septic Patients as Measured by Endogenous Lithium Clearance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intensive care patients and healthy controls

Brief summary: Renal lithium clearance is hypothesized to be a useful indicator of renal tubular function.

In this study lithium clearance will be monitored in patients with sepsis associated acute kidney injury and in healthy controls.

Detailed description: Lithium is almost completely reabsorbed in the proximal tubule in parallel with sodium and water. What is not reabsorbed here is assumed to be fully excreted in urine, giving a reasonably accurate measurement of sodium reabsorption in the proximal tubule. Endogenous lithium clearance will be measured by inductively coupled plasma mass spectrometry (ICP-MS). The Gomez equations will be applied to calculate efferent arteriolar resistance, afferent arteriolar resistance, glomerular hydrostatic pressure, glomerular filtration pressure, and glomerular oncotic pressure. N-acetyl-β-D glucosaminidase (NAG) and NGAL, markers of tubular injury, will be measured by a spectrophotometric method using a commercially available kit. Routine blood and urine analyses will be performed at the Diagnostic Clinic Laboratory, University Hospital of North Norway, Tromsø.

Eligibility criteria: Inclusion criteria sepsis associated acute kidney injury:

* Sepsis diagnosed or suspected
* Age \>18 years

Inclusion Criteria healthy controls:

* Previously healthy individuals
* Age \>18 years

Exclusion Criteria:

Oliguria or renal impairment due to other causes than sepsis. Pregnancy or breast-feeding.

Primary outcomes:
measure: Renal lithium clearance
timeFrame: Repeated measures between 07:00-20:00
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
References:
Clinical trial NCT05944835: Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents
Official title: Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Surgery
Keywords: Endoprosthesis
proximal neck
numerical simulation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient who has been treated for an aortoiliac aneurysm with a standard Medtronic Endurant aortic stent, standard Gore Excluder or conformable Gore Excluder

Brief summary: Endoprosthesis treatment of aortic pathologies has become the reference in the vast majority of situations. The success of this treatment is conditioned by the choice of the endoprosthesis which must be as adapted as possible to the anatomy. This choice is currently based on manual geometric measurements performed on the preoperative scanner using conventional image processing software.

The morphological result of the implantation of the endoprosthesis in the aorta is obtained by a CT scan carried out postoperatively. This scanner makes it possible to define the positioning of the endoprosthesis, the apposition surfaces between the aorta and the endoprosthesis and to predict the long-term result.


Eligibility criteria: Inclusion Criteria:

- Any patient who has been treated for an aortoiliac aneurysm with a standard Medtronic Endurant aortic stent, standard Gore Excluder or conformable Gore Excluder

Exclusion Criteria:

* Patient who has objected to the use of their data.
* No preoperative scanner available or insufficient injection quality
* Preoperative scanner with slice thickness greater than 3 mm

Primary outcomes:
measure: The accuracy of numerical simulation to predict the deployment at the level of the proximal neck of different types of standard stents used for the treatment of an aortoiliac aneurysm.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
Study officials:
References:
Clinical trial NCT00958035: Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotrichosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).


Eligibility criteria: Inclusion Criteria:

* African American/ethnic black
* Adults at least 18 years of age
* Eyelash prominence assessment of minimal or moderate

Exclusion Criteria:

* Subjects with uneven lashes or longer on one side than the other
* Any eye disease or abnormality
* Eye surgery
* Severe hyperpigmentation around the eye
* Eyelash implants
* Eyelash extension application
* Any use of eyelash growth products within 6 months
* Any use of prescription eyelash growth products
* Treatments that may affect hair growth
* Requiring eye drop medications for glaucoma

Primary outcomes:
measure: Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4
timeFrame: Month 4
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05543135: Aetiology of Asymmetrical Hearing Loss: A Retro-spective Study Thesis Submitted for Partial Fulfillment of Master Degree in Audio-Vestibular Medicine
Official title: Aetiology of Asymmetrical Hearing Loss: A Retro-spective Study Thesis Submitted for Partial Fulfillment of Master Degree in Audio-Vestibular Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asymmetrical Hearing Loss
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with asymmetrical hearing loss with age ranging 6 years old and more.

Brief summary: Hearing loss maybe: -Symmetrical: in which the severity and pattern of hearing loss are the same in each ear. Or -Asymmetrical: is defined as binaural difference in bone conduction thresholds of \>10 dB at two consecutive frequencies or \>20 dB at one frequency (0.25-8.0 kHz), Poorer speech perception will often accompany poorer hearing and may be the reason for the patient's presentation .Unilateral or asymmetrical sensorineural hearing loss is important to discern, as it is an important risk factor for auditory nerve tumors (i.e. vestibular schwannoma) which is a life threatening condition, and in such cases further investigation is required (i.e. MRI scan) unless there is a known reason for the asymmetry, Several reports have recommended that further evaluation, especially expensive imaging studies, be conducted to rule out acoustic tumors when AHL is present


Eligibility criteria: Inclusion Criteria:

* Age: 6 years old and more.
* Sex: male and female.

Exclusion Criteria:

* Age: less than 6 years old.
* Patients with symmetrical hearing loss.

Primary outcomes:
measure: Asymmetrical hearing loss
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Dunn CC, Tyler RS, Oakley S, Gantz BJ, Noble W. Comparison of speech recognition and localization performance in bilateral and unilateral cochlear implant users matched on duration of deafness and age at implantation. Ear Hear. 2008 Jun;29(3):352-9. doi: 10.1097/AUD.0b013e318167b870.
citation: Margolis RH, Saly GL. Asymmetric hearing loss: definition, validation, and prevalence. Otol Neurotol. 2008 Jun;29(4):422-31. doi: 10.1097/MAO.0b013e31816c7c09.
citation: Peng AW, Salles FT, Pan B, Ricci AJ. Integrating the biophysical and molecular mechanisms of auditory hair cell mechanotransduction. Nat Commun. 2011 Nov 1;2:523. doi: 10.1038/ncomms1533.
citation: Plack CJ, Barker D, Hall DA. Pitch coding and pitch processing in the human brain. Hear Res. 2014 Jan;307:53-64. doi: 10.1016/j.heares.2013.07.020. Epub 2013 Aug 11.
Clinical trial NCT07019935: Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER)
Official title: Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Insufficiency
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 1000
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: Adult patients undergoing transcatheter mitral valve edge-to-edge repair (TEER) during hospitalization were enrolled.

Brief summary: Mitral regurgitation (MR) is one of the most common valvular heart diseases in China, causing heart failure. Patients with moderate to severe MR have a very poor clinical prognosis if no intervention is performed. When symptoms are still poorly controlled after guideline-directed medical therapy (GDMT) or when surgical intervention is not suitable, transcatheter mitral valve edge-to-edge repair (TEER) can improve the patient's quality of life and reduce the hospitalization rate and mortality rate. However, some patients develop into afterload mismatch (AM) after TEER, persistent adverse ventricular remodeling, and a high mortality rate, which limits the surgical benefits of TEER surgery in these MR patients. Therefore, how to scientifically predict AM and intervene as early as possible has become a research hotspot for optimizing the postoperative management of TEER patients. Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER) study is a prospective cohort study including adult patients undergoing TEER during hospitalization. We aim to evaluate whether the patients develop into AM after TEER, evaluate the prognostic risk factors of AM and construct a prognostic clinical model to guide clinical decision-making.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing transcatheter mitral valve edge-to-edge repair (TEER) during hospitalization.
* Aged over 18 yrs.

Exclusion Criteria:

* Patients unable to provide written consent.

Primary outcomes:
measure: Afterload mismatch
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT04352335: Change in NLR and Survival Among Advanced Lung Cancer Patients Receiving ICIs With Immunomodulator
Official title: Change in Neutrophil to Lymphocyte Ratio (NLR) and Survival Among Advanced Lung Cancer Patients Receiving Immune Checkpoint Inhibitors With Immunomodulator: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Lung Cancer
Keywords: neutrophil to lymphocyte ratio (NLR)
immunomodulator
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung cancer undergoing ICIs with or without immunomodulatory drug

Brief summary: The main objective of this study is to evaluate the change of neutrophil to lymphocyte ratio (NLR) after 6-week treatment of immune checkpoint inhibitors (ICIs) with or without immunomodulatory drugs and recognize the effect of post-treatment NLR and overall survival in advanced lung cancer patients by retrospective review.

Detailed description: In recent years, the therapeutic strategies for lung cancer have been enriched with small molecular targeted therapy and immunotherapy. In this retrospective study, we will observe the change in NLR and explore its possible association with survival among advanced lung cancer patients receiving Immune checkpoint inhibitors (ICIs) with and without such immuno-modulator, Astragalus Polysaccharide Injection. It can be used to understand the relationship between NLR values and the survival rate of lung cancer patients after ICIs treatment. Physicians can refer to this result to give patients the suitable treatment recommendations.

Eligibility criteria: Inclusion Criteria

* Aged 20 years and older.
* Patients who have been given a diagnosis of lung cancer.
* Previously advanced lung cancer patients first treated with ICIs from Oct 1, 2015 to Oct 31, 2019.

Exclusion Criteria

* Patients who have no hematological laboratory data available at baseline (within 3 days prior to ICI treatment) and the 6th week (± 2 weeks) after ICI treatment initiation.

Primary outcomes:
measure: Neutrophil to lymphocyte ratio (NLR)
timeFrame: Baseline, 4~8 week
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 4 years
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Shih-Ming TSAI, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03407235: Simulating Laparoscopy With an Eye Patch
Official title: Laparoscopic Skill Acquisition; Can the Loss of Depth Perception Associated With Laparoscopic Surgery be Adequately Simulated by an Eye Patch?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Training
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept perception) to investigate acquisition of laparoscopic skills.

Detailed description: Healthy volunteers who are laparoscopic novices will perform four validated laparoscopic training exercises on both the laparoscopic computerized trainer and on a simple box trainer with an eye patch.

Novices will be allowed to familiarize themselves with the laparoscopic instruments and will be shown short video clips to demonstrate tasks.

They then will have five minutes to complete each of the four tasks. They will return 1-2 weeks later to complete the same process on the alternative training method.

All participants will complete the tasks on both the computerized lap simulator and the box trainer.

Eligibility criteria: Inclusion Criteria:

* Laparoscopic Novices
* 20-40 years
* All genders

Exclusion Criteria:

* Previous laparoscopic surgical experience

Primary outcomes:
measure: Time to completion of laparoscopic tasks.
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University Of Nottingham
city: Derby
country: United Kingdom
facility: The Medical School, University of Nottingham, Royal Derby Hospital.
Study officials:
References:
Clinical trial NCT03967535: Connectomics in Psychiatric Classification
Official title: Connectomics in Psychiatric Classification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Dementia Alzheimers
Frontotemporal Dementia
Pick's Disease With Dementia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals between the ages of 45-85 with a diagnosis of Dementia.

Brief summary: Washington University Early Recognition Center is conducting a research study to examine brain functional connectivity and network patterns in participants with dementia.

Detailed description: This study extends the assessment of brain connectivity and function, being conducted in the Human Connectome Project (HCP), to psychiatrically ill populations. The HCP consortium has made significant improvements in MRI instrumentation, data acquisition, preprocessing, and analysis. These improvements are currently providing publicly available data on the structure, function, and connectivity of young adult human (age 22-35) brains at unprecedented spatial resolution, temporal resolution, and accuracy. This study will focus on individuals aged 45-85 years who have a diagnosis of dementia, or are healthy controls. Additionally, similar to the HCP, the investigator will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. DNA will be collected non-invasively from saliva. Furthermore, this investigator will study cortisol levels in hair samples as an additional assessment to help characterize brain imagining findings.

Eligibility criteria: Inclusion Criteria:

* Ages 45-85
* Has consented to participate or has an LAR present that has consented to participate
* DSM-5 diagnosis of Dementia

Exclusion Criteria:

* Any genetic disorder, such as cystic fibrosis or sickle cell disease
* Multiple Sclerosis
* Cerebral Palsy
* Loss of consciousness for \>30 minutes
* Pregnancy
* Hospitalization for stroke, brain aneurysm, brain hemorrhage, or subdural hematoma

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI) Brain Imaging
timeFrame: within one month of study enrollment
Secondary outcomes:
measure: DNA testing through saliva
timeFrame: within one month of study enrollment
Other outcomes:
measure: Hair sample for cortisol measurement
timeFrame: within one month of study enrollment
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT01134835: PPAR-gamma: a Novel Therapeutic Target for Asthma?
Official title: PPAR-gamma: a Novel Therapeutic Target in Asthma?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the treatment of asthma.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 of either sex with a clinical diagnosis of asthma,
* FEV1 ≥ 60% predicted and an increase in FEV1 of greater than 12% following inhaled salbutamol 400μg or Peak Expiratory Flow (PEF) variability \>12% during run-in.
* Allowed medication: 0-800μg inhaled beclomethasone diproprionate or equivalent and as required short acting beta agonist.

Exclusion Criteria:

* Current smoking,
* \> 10 pack years smoking history,
* Treatment with leukotriene antagonists,
* Liver or cardiovascular disease,
* Oral steroid treatment or exacerbation within 6 weeks,
* Females who are pregnant, lactating or not using adequate contraception,
* Any contra-indication to pioglitazone (hypersensitivity to pioglitazone, cardiac failure, history of cardiac failure, hepatic impairment, diabetic ketoacidosis),
* Oral or insulin treatment for diabetes,
* Treatment with gemfibrozil or rifampicin.

Primary outcomes:
measure: FEV1 after 12 weeks treatment
timeFrame: week 12
Secondary outcomes:
measure: Change in symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
References:
citation: Anderson JR, Mortimer K, Pang L, Smith KM, Bailey H, Hodgson DB, Shaw DE, Knox AJ, Harrison TW. Evaluation of the PPAR-gamma Agonist Pioglitazone in Mild Asthma: A Double-Blind Randomized Controlled Trial. PLoS One. 2016 Aug 25;11(8):e0160257. doi: 10.1371/journal.pone.0160257. eCollection 2016.