louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05836714: Delirium Detection During Routine Patient Care
Official title: Validation of a Viable Delirium Detection Test Performed by Nurses and Physicians During Routine Patient Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Keywords: DELIRIUM
DIAGNOSIS
4AT
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-05-01
Enrollment: 365
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients \>70 yrs old, hospitalized in the department of internal medicine

Brief summary: Despite the presence of validated tests, there are still drawbacks to implementing delirium diagnosis tests in hospital wards. We developed a new, simple, easy to implement user friendly delirium diagnostic test that is likely to facilitate implementation in many departments. The present study will compare the new test to a well validated older test - 4AT.

Detailed description: Delirium is characterized by an acute onset altered mental status and/or a confusional state. Although delirium has been known since ancient times, the condition is often not diagnosed, documented, evaluated, and managed. Early detection of delirium in hospitalized patients may be critical, particularly on internal medicine wards, as mental deterioration in the elderly can be the first sign of preventable diseases and disorders that precipitate delirium. Nevertheless only 15%-35% of cases of delirium in hospitalized patients are identified by the treating staff and documented in the medical records. The main reasons for this shortcoming are insufficient awareness to emerging delirium, and excessive work load.

We have recently developed and implemented in our Department of Internal Medicine a new diagnostic tool for delirium. This test, designated R\&M, is based on a combination of RADAR (Recognizing Acute Delirium As part of your Routine), performed by the nurses during medication dispensing, and MOYB (Months Of the Year Backwards), performed by residents during the routine rounds in patients with positive RADAR. Both tests are online and saved in the patients' electronic records.

The purpose of this study is to demonstrate non-inferiority of R\&M compared to 4AT (Attention, Abbreviated mental test, Alertness, Acute onset Test), an old and well validated delirium recognition test. The sample size required for a sensitivity of 95% and a 95% confidence interval was calculated to be n=365, assuming delirium prevalence of \>20% in elderly patients hospitalized in internal medicine wards.

Eligibility criteria: Inclusion Criteria:

- patients \>70 yrs old, hospitalized in the department of internal medicine

Exclusion Criteria:

* severe dementia

Primary outcomes:
measure: Validation of a viable delirium detection test care.
timeFrame: ONE YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai-Zion Medical Center
Study officials:
affiliation: BNAI-ZION MC HAIFA ISRAEL
name: RON OLIVEN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04088214: Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus
Official title: Case Series Regarding the Efficacy of the Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Hallux Valgus and Bunion
Keywords: Arthroscopy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: case series
Primary purpose: TREATMENT

Brief summary: Lateral soft tissue release is commonly performed as part of the surgical correction of hallux valgus. This study will look at the results form a series of patients whom have underwent the arthroscopic lateral soft tissue release.


Eligibility criteria: Inclusion:

* \>18 and legally fit for consent
* Symptomatic hallux valgus with HVA \>15 degrees

Exclusion:

* Active physical or mental disorders that could affect rehabilitation including

  * Other conditions affecting ambulation: lower limb injury, neuromuscular problems etc.
  * Mental incapacitation
* Previous hallux valgus surgery

Primary outcomes:
measure: HVA
timeFrame: 12 weeks post-surgery
measure: HVA
timeFrame: 52 weeks post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: CUHK
Study officials:
affiliation: Assistant Professor
name: Samuel KK Ling, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00542295: Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome
Official title: Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Lead sponsor: Laboratoires Mayoly Spindler
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 400
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 assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design


Eligibility criteria: Inclusion Criteria:

* male or female ambulatory patients, aged 18-75 years
* with IBS as defined by Rome III criteria

Exclusion Criteria:

* Functional bowel disorder other than IBS,
* Underlying cause for symptomatology, which excludes IBS diagnosis,
* Gastro-intestinal cancer or significant gastro-intestinal surgical background,
* Any acute/uncontrolled systemic pathology

Primary outcomes:
measure: Subject self assessment of abdominal pain/discomfort
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: IBS life impact, overall treatment assessment, concomitant factors
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Miskolc
country: Hungary
city: Miskolc
country: Hungary
city: Siofolk
country: Hungary
city: Szeged
country: Hungary
city: Székesfehérvár
country: Hungary
city: Bydgoszcz
country: Poland
city: Katowice
country: Poland
city: Olawa
country: Poland
city: Szczecin
country: Poland
city: Wroclaw
country: Poland
city: Wroclaw
country: Poland
Study officials:
name: Philippe Ducrotte, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT00127595: Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract
Official title: A Phase II Monocentric Study of Oxaliplatin in Combination With Gemcitabine in Patients With Advanced/Metastatic Transitional Cell Carcinoma of the Urothelial Tract
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Transitional Cell
Keywords: carcinoma of the urothelial tract
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-08-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.


Eligibility criteria: Inclusion Criteria:

* Transitional cell carcinoma
* Histologically-proven
* Locally advanced unresectable or metastatic
* With at least one measurable target
* Informed consent signed

Exclusion Criteria:

* Previous chemotherapy
* Previous radiotherapy
* Performance status \>=2
* Peripheral neuropathy \>=1

Primary outcomes:
measure: response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
Secondary outcomes:
measure: overall survival
measure: disease free survival
measure: toxicity
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Christine THEODORE, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03717714: Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis
Official title: A Randomized, Double-blind, Active Controlled, 12-week Follow-up, Pilot Study to Evaluate the Safety and Efficacy of Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Lead sponsor: Vietstar Biomedical Research
Sponsor class: INDUSTRY
First posted: 2018-10-24
Enrollment: 90
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: The objectives of this study is to examine the Safety and Eﬃcacy of black yeast beta-glucan produced from Aureobusidium pulluluns SM-2001 (Polycan), in combination with glucosamine in reducing knee osteoarthritis (OA) associated symptoms. This study is a double-blind, randomized, active-controlled trial conducted with 100 OA patients, aged 35-80 years using a formulated product


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of knee osteoarthritis (OA)
* OA ranging from grade 1 to grade 3 by Kellgren and Lawrence system
* Agree to participate into the study

Exclusion Criteria:

* OA ranging from grade 4 by Kellgren and Lawrence system
* Allergic or contradicted with oral NSAIDs (Meloxicam)
* Pregnant and breastfeeding women.

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) changes at 12 weeks in the three groups
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Number of dose of rescue medication (Meloxicam 7.5mg) used in the three groups.
timeFrame: Through study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: 198 Hospital
Study officials:
References:
Clinical trial NCT00562614: Safety and Effect of Oral Doses of 5mg or 10mg of SLx-2101 for 14 Days in Patients With Hypertension
Official title: A Pilot Phase IIa Randomised, Double-blind, Placebo-controlled, Crossover Study to Examine the Safety, Tolerability and Pharmacodynamic Effects on Blood Pressure of Repeat Oral Doses of SLx-2101 5 mg or 10 mg Once Daily for up to 14 Days in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Response Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-11-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose is to determine the effect of SLx-2101 dosed at 5mg or 10mg for 14 days on systolic, diastolic pressures and heart rate in patients with hypertension.

Detailed description: 1. Placebo-corrected supine peripheral systolic, diastolic blood pressures and heart rate
2. 24 hour ambulatory blood pressure and heart rate
3. Safety and tolerability

Eligibility criteria: Inclusion Criteria:

* Male or female subjects between 18 and 70 years old, inclusive
* Moderate to severe hypertension
* Body weight within a body mass index of 18-32kg/m2

Exclusion Criteria:

* The subject is receiving more than three antihypertensive agents
* A history of drug abuse
* Exposure to a new chemical entity within 3 months prior to the first day of dosing

Primary outcomes:
measure: Peripheral systolic, diastolic blood pressures and heart rates
timeFrame: 14 days
Secondary outcomes:
measure: Adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel, Institute for Clinical Pharmacology
Study officials:
affiliation: PAREXEL, Institute for Clinical Pharmacology
name: Georg Golor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04336995: Exercise Pulmonary Transit Time
Official title: Echocardiographic Assessment of Pulmonary Transit Time Following Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure, Diastolic
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: small pilot study to test technical feasibility
Primary purpose: DIAGNOSTIC

Brief summary: The study seeks to measure pulmonary transit time via contrast-echocardiography before and after exercise.

Detailed description: The ability to measure the amount of blood in the lungs using heart-ultrasound (echocardiography) can be useful to estimate how much fluid is in a patient's circulation, which can influence diagnosis and treatment of certain types of heart failure. In some patients, the amount of fluid is normal at rest, but can increase with activity and thus a diagnosis of heart failure can only be made after exercising. Currently, the amount of fluid is measured invasively. We have shown that echocardiography can measure the amount of fluid in the lung circulation at rest without the need for an invasive procedure. We now seek to find out if we can make a similar measurement after exercise. If successful, the need for catheter procedures may be reduced in certain types of heart failure.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Able to give informed consent

Exclusion Criteria:

1. Known allergic reaction to Definity or Optison ultrasound contrast
2. Pregnancy/Nursing - as assessed/disclosed by the participant

Primary outcomes:
measure: Pulmonary Transit Time
timeFrame: 3-10 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: VHVI
state: Tennessee
Study officials:
affiliation: VUMC
name: Ken Monahan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05921695: The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Heat Stroke
Official title: The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Patients With Heat Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heat Stroke
Keywords: heat stroke
normal saline
acute kidney injury
mortality
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Yiwu Central Hospital
name: Jinhua People's Hospital
name: Jinhua Municipal Central Hospital
name: Dongyang People's Hospital
name: Lanxi People's Hospital
First posted: 2023-06-27
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare the effect of high chlorine solution such as normal saline and non-high chlorine solution such as sodium lactate ringer's solution on renal function in patients with heat stroke. The main question it aims to answer is whether limiting the amount of normal saline infusion during emergency department can lower the incidence of acute kidney injury and mortality in patients with heat stroke.

Participants will receive a free normal saline infusion during the emergency department according to the study design, or a restricted normal saline infusion while using sodium lactate Ringer's instead.

Researchers will compare the normal saline infusion group and sodium lactate Ringer's group to see if limiting the amount of normal saline infusion during emergency department can lower the incidence of acute kidney injury and mortality in patients with heat stroke.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* diagnosed as heat stroke
* Informed consent from patients or family members.

Exclusion Criteria:

* need immediate cardiopulmonary resuscitation
* transferred from another hospital
* with original end-stage renal disease or dialysis
* with severe organ damage
* pregnant women

Primary outcomes:
measure: Acute kidney injury
timeFrame: up to 90 days
Secondary outcomes:
measure: Continuous renal replacement therapy
timeFrame: up to 90 days
measure: length of ICU stay
timeFrame: up to 90 days
measure: in-hospital mortality
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Yiwu
country: China
facility: Yiwu Central Hospital
state: Zhejiang
city: Yongkang
country: China
facility: YongKang First People&#39;s Hospital
state: Zhejiang
city: Dongyang
country: China
facility: Dongyang People's Hospital
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
city: Jinhua
country: China
facility: Jinhua People's Hospital
city: Lanxi
country: China
facility: Lanxi People's Hospital
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Lan Chen, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02975895: Outcome of Different IOLs in Patients With and Without Uveitis
Official title: Outcome With Hydrophobic and Hydrophilic Intraocular Lens in Patients With and Without Uveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uveitis
Cataract
Inflammation
Posterior Capsule Opacification
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2016-11-29
Enrollment: 56
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: Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual acuity. In most cases it can be managed with surgery, removing the own lens and replacing it with an artificial lens, intraocular lens (IOL). These lenses are made in different materials with different properties.

Uveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this disease have an increased risk of developing cataract due to the inflammation itself and treatment with steroids. They also have an increased risk of complications during surgery and postoperatively. In this group the selection of IOL might be of greater importance.

The aim of this prospective randomized controlled study is to compare the outcome of hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis


Eligibility criteria: Inclusion Criteria:

* Cataract requiring surgery
* Ability to understand and sign consent form

Exclusion Criteria:

* Extensive corneal scarring
* Other eye surgery less than 3 months before inclusion
* Unregulated glaucoma
* Active uveitis (increased inflammation and treatment less than 3 months before inclusion)
* Intraoperative complications (capsular tear or vitreous loss)

Primary outcomes:
measure: Change in inflammatory response
timeFrame: Preoperatively and at seven occasions within two years postoperatively
Secondary outcomes:
measure: Evaluation of posterior capsule opacification after six months
timeFrame: Six months (plus or minus 30 days) postoperatively
measure: Evaluation of posterior capsule opacification after one year
timeFrame: One year (plus or minus 30 days) postoperatively
measure: Evaluation of posterior capsule opacification after two years
timeFrame: Two years (plus or minus 2 months) postoperatively
measure: Change in best corrected visual acuity assessed in decimal using Snellen charts
timeFrame: Preoperatively and at six occasions within two years postoperatively
measure: Complications
timeFrame: Preoperatively and at seven occasions within two years postoperatively
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology
Study officials:
affiliation: Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology
name: Madeleine Zetterberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06877195: Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory
Official title: Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory: Mid-term Clinically Driven Re-rivascularization Events Comparison Between Sites Treated With VEST, Sites Treated With Bare Vein, Sites Treated With Other Conduits and de Novo Lesions on the Native Vessels
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Cardiovascular Disease
Keywords: Coronary Artery Bypass Graft
Lead sponsor: Cardiochirurgia E.H.
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicentre randomised prospective study aimed at verifying medium-term patency of venous grafts on the right coronary artery territory, by clinical and/or instrumental follow-up with particular attention to clinically driven re-revascularisation events regarding the site of new lesions (granularly comparing sites already treated with VEST, sites treated with bare vein, sites treated with other conduits, de novo lesions on the native).


Eligibility criteria: Inclusion Criteria:

* combined or isolated interventions
* adequate vein calibre
* adequate graft flowmetry

Exclusion Criteria:

* inability to implant due to calibre disparity or inadequate flowmetry

Primary outcomes:
measure: Ri-revascularization of grafted territory
timeFrame: Till end of study (at least three years)
Secondary outcomes:
measure: Major Cardiovascular and Cerebrovascular Events (MACCE)
timeFrame: Till end of study (at least three years)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: European Hospital
Study officials:
affiliation: Unicamillus
name: Luca Paolo Weltert, MD
role: PRINCIPAL_INVESTIGATOR
References: