louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05264077: Efficacy of Dexmedetomidine vs Midazolam for Early Extubation in Critically Ill Agitated Patients Undergoing Weaning
Official title: Efficacy of Dexmedetomidine Versus Midazolam for Early Extubation in Critically Ill Agitated Patients Undergoing Weaning
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Agitation, Emergence
Lead sponsor: Sheikh Zayed Medical College
Sponsor class: OTHER_GOV
First posted: 2022-03-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Comparison of effect of dexmedetomidine and midazolam in icu patients who put on mechanical ventilation and show agitation on weaning.Selection of better agent minimises the drug related side effects like respiratory depression but also helps in weaning for early extubation,give hemodynamic stability and reduce morbidity and mortality in icu..


Eligibility criteria: Inclusion Criteria:

* all patients with age \<60 irrespective of gendre

Exclusion Criteria:

- Patients who refuse to give consent, severely altered conscious level (GCS \< 8/15), traumatic injury causing hypoxemia e.g., severe head / chest / facial trauma or pneumothorax, severe pneumonia, arrhythmia, impaired hearing or blindness, severe hepatic or renal disease, on neuromuscular blocking agents, recent myocardial infarction, use of anti-psychotics, hypersensitivity to any of the drug under study.

Primary outcomes:
measure: Effective sedation in icu patients lead to successful 1weaning in icu patients
timeFrame: Upto 48 hrs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06111677: SOFA and APACHE II Scoring Systems for Predicting Outcome of Neurological Patients Admitted in a Tertiary Hospital Intensive Care Unit
Official title: SOFA and APACHE II Scoring Systems for Predicting Outcome of Neurological Patients Admitted in a Tertiary Hospital Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurologic Disorder
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 153
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients admitted in ICUs with neurological diagnosis from January 1, 2022 to December 31, 2022

Brief summary: The aim of this study was to compare the discriminative power of commonly used scoring systems, namely the sequential organ failure assessment (SOFA) and acute physiology and chronic health evaluation II (APACHE II) in the intensive care unit of a tertiary care hospital.

Detailed description: This was a retrospective cross-sectional study including patients admitted to the ICU of TU Teaching Hospital with a neurological diagnosis from January 1, 2022, to December 31, 2022. This study uses data collected prospectively as part of the Nepal Intensive Care Research Foundation (NICRF) dataset. The ICU database contained information for all components of the APACHE II and SOFA score with physiological data collected for the length of ICU, and hospital stay. Both SOFA and APACHE II were calculated from the admission data or if not available from the earliest data recorded after admission in ICUs.

Eligibility criteria: Inclusion Criteria:

* Patients admitted with neurological diagnosis in ICUs

Exclusion Criteria:

* Patients with missing data
* Patients with ICU length of stay \< 24 h

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lalitpur
country: Nepal
facility: Sumit Shahi
Study officials:
References:
Clinical trial NCT01140477: Toric Intraocular Lens Following Cataract Surgery
Official title: A Prospective Multicenter Clinical Trial To Evaluate the Effectiveness of A Toric Accommodating Posterior Chamber Silicone Intraocular Lens Designed To Provide Near, Intermediate, And Distance Vision And Reduce The Effects Of Preoperative Corneal Astigmatism On Postoperative Refraction Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-06-09
Enrollment: 229
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 objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a clinically documented diagnosis of age-related cataract
* Subjects must require a lens power from 16 to 27 diopters
* Subjects must have predicted post-operative corneal astigmatism between 0.83D and 2.50D, as determined by the Toric Calculator

Exclusion Criteria:

* Subjects with any anterior segment pathology for which extracapsular/ phacoemulsification cataract surgery would be contraindicated.
* Subjects with diagnoses of degenerative visual disorders.
* Subjects with conditions associated with increased risk of zonular rupture.
* Subjects who have had previous corneal surgery in the planned operative eye.
* Subjects with irregular corneal astigmatism.
* Subjects with clinically significant retinal pigment or epithelium/macular changes.
* Subjects with chronic use of systemic steroids or immunosuppressive medications.
* Subjects either concurrently participating in another clinical trial or have participated in another clinical trial within 60 days prior to enrollment in this study.
* Subjects with a difference in corneal astigmatism measured with the IOL Master and the topographer greater than 0.5 D using vector analysis.

Primary outcomes:
measure: Percent Reduction in Absolute Cylinder
timeFrame: 120 - 180 day postoperative visit
Secondary outcomes:
measure: Lens Misalignment
timeFrame: 120 - 180 day postoperative visit
measure: Visual Acuity
timeFrame: 120 - 180 day postoperative visit
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: B&L Surgical
state: New Jersey
Study officials:
affiliation: Pepose Vision Institute
name: Jay Pepose, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00360477: FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy
Official title: Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Calculi
Keywords: Kidney stone removal surgery
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2006-08-04
Enrollment: 59
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 patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures.


Eligibility criteria: Inclusion Criteria:

* The patient has kidney stones that require treatment (tx) with percutaneous stone removal
* 18 years of age or over

Exclusion Criteria:

* Patient mentally impaired, have a chronic pain syndrome or disorder, or any condition that might alter the sensation of pain
* Patient taking coumadin
* Pre-existing percutaneous nephrostomy

Primary outcomes:
measure: To determine which method of treatment causes the least pain to the patient.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center-Department of Urology
state: California
Study officials:
affiliation: UC Irvine, Department of Urology
name: Michael K Louie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06422247: Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy
Official title: Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral T-cell Lymphoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-05-20
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with peripheral T-cell lymphoma in Japan initiating second-line systemic therapy

Brief summary: The purpose of this study is to describe the therapeutic practices and the prognosis of patients with relapsed or refractory peripheral T-cell lymphoma in Japan


Eligibility criteria: Inclusion Criteria:

* Male or female participants with a confirmed diagnosis of the specific subtypes of peripheral T-cell lymphoma (PTCL) according to The World Health Organization (WHO) classification of lymphoid neoplasm, 4th edition defined by WHO and International Agency for Research on Cancer (IARC).
* Participates aged ≥18 years of age at diagnosis of PTCL.
* Participates who have been treated with a systemic therapy for PTCL and have initiated a systemic therapy as a second-line therapy for relapsed or refractory PTCL between April 1, 2018 and March 31, 2023.

Exclusion Criteria:

* Participates who have medical history of peripheral T-cell lymphoma (PTCL) treatment by unapproved drug in Japan as of 31 March 2024 or off-label drug for PTCL in Japan as of 31 March 2024.
* Participates who have medical history of participation to a separately defined registration study for regulatory approval in PTCL.
* Participates who have medical history of PTCL treatment in a separately defined clinical study with intervention by on-label regimen for PTCL.
* Participates judged to be inappropriate for enrollment in this study by the site investigator.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: From baseline until date of death from any cause or last known alive date, assessed up to 6 years
Secondary outcomes:
measure: Participant baseline demographics
timeFrame: Baseline
measure: Participant baseline clinical characteristics
timeFrame: Baseline
measure: Participant treatment sequence from initial diagnosis
timeFrame: From date of initial diagnosis until death from any cause or last known alive date, assessed up to 6 years
measure: Frequency of treatment regimen by treatment line
timeFrame: End date of each treatment-line of therapy, assessed up to 6 years
measure: Time to next treatment line or death (TTNT)
timeFrame: From date of first-line therapy initiation until death from any cause or last known alive date, assessed up to 6 years
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Mebix, Inc
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02618447: 4D Phase Contrast MR: Hypertrophy in Liver Cancer
Official title: 4D Phase Contrast MR: Validation and Evaluation of Hypertrophy in Liver Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Cancer
Cancer of the Liver
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The investigators hypothesize that 4Dimensional Phase Contrast Magnetic Resonance Angiography (4D PC MRA) evaluation of portal venous flow predicts underlying liver function and hypertrophic potential in patients with liver cancer presenting for portal vein embolization (PVE). 4D PC MRA may provide a non-invasive measure of liver function that could help determine which patients could safely and successfully undergo PVE and subsequent resection of tumor. By comparing 4D PC MRA results with invasive catheter measurements the investigators will validate the flow findings. Further regression/correlation analysis with functional measures of the liver (HIDA scans), volumetrics, Doppler flow analysis, histology, and outcomes will help the investigators to determine the ability of 4D PC MRA to predict functional status and hypertrophic potential of the liver prior to PVE and hepatectomy allowing for better patient selection and reduced morbidity/mortality.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of malignant liver tumor
* Clinically referred for portal vein embolization
* At least 18 years of age
* Willing and able to provide informed consent

Exclusion Criteria:

* Documented or reported contrast allergy
* Unable to receive or tolerate MRI scan after evaluation of MRI screening form
* GFR (glomerular filtration rate) \< 30 on labs drawn within 6 weeks of imaging.

Primary outcomes:
measure: Ability of the 4D PC MRA to measure portal venous flow findings compared to reference standards of catheter-based flow quantification
timeFrame: Up to 6-8 weeks post PVE
measure: Ability of the 4D PC MRA to measure flow velocities as compared to reference standards of the Doppler Flow Analysis
timeFrame: Up to 6-8 weeks post PVE
measure: Ability of the 4D PC MRA to measure liver function
timeFrame: Up to 6-8 weeks post PVE
measure: Ability of the 4D PC MRA to measure hypertrophic potential (liver function is preserved)
timeFrame: Up to 6-8 weeks post PVE
measure: Ability of the 4D PC MRA to measure flow direction of flow as compared to reference standards of the Doppler Flow Analysis
timeFrame: Up to 6-8 weeks post PVE
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Nael E Saad, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00837447: Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses
Official title: Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2009-02-05
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective, randomized study was to compare pain, functional outcome and ranges of motion of the knees in patients receiving either a standard posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.

Detailed description: The main goals of total knee arthroplasty are pain relief and improvement of function and range of motion. The purpose of this study was to compare ranges of motion of the knees in patients receiving either a standard posterior crucaite-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.

Eligibility criteria: Inclusion Criteria:

* osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties

Exclusion Criteria:

* inflammatory arthritis
* osteoarthritis of the hip causing pain or restricted mobility
* a foot or ankle disorder which limited walking
* dementia or a neurological disorder including a past history of stroke which affected mobility

Primary outcomes:
measure: Change in Knee Society Knee Score
timeFrame: baseline and 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Young-Hoo Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05527847: Peers EXCEL Trial to Improve Glycemic Control
Official title: A Pilot Randomized Clinical Trial (RCT) to Examine the Benefits of a Culturally Adapted Peer Support and Self-Management Intervention to Improve Glycemic Control in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: African-American
medication adherence
diabetes self-management
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to gather input about the value of adding a newly developed diabetes self-management program to an existing diabetes self-management program. Participants will self-identify as African-American/Black with type 2 diabetes, and prescribed a diabetes medication. Participants can expect to be in the study for 6 months.

Detailed description: Both programs utilized in this study focus on topics such as diet, exercise, and stress. Both programs offer ideas to manage diabetes symptoms, discuss appropriate exercises, provide guidance on healthy eating, review the use of medicine, and offer tips on communicating with healthcare providers and voicing concerns to family members.

The new program is culturally-tailored for African Americans and focuses on helping patients take their medicines as prescribed.

The purpose of this research study is to evaluate this newly developed combined diabetes self-management program.

Eligibility criteria: Inclusion Criteria:

* Between 18-90 years old
* Self-identify as African-American
* Diagnosis of Type 2 diabetes
* Able to speak/read English
* Self-report having a primary care provider who prescribes one diabetes medication
* Diagnosed with diabetes for ≥1 year at point of care
* Will reside in the geographical area throughout the study period
* Self-reported nonadherence on the DOSE-nonadherence survey
* ≥7.5% A1C

Exclusion Criteria:

* Self-reported bipolar or personality disorders, schizophrenia, Alcohol and Other Drug Abuse (AODA), dementia
* Older adults who have a history of severe hypoglycemia requiring medical assistance or glucagon administration
* Participating in another lifestyle or medication adherence program

Primary outcomes:
measure: Change in blood glucose (hemoglobin A1C)
timeFrame: Baseline, 2 months, 6 months
Secondary outcomes:
measure: Medication adherence
timeFrame: Baseline, 2 months, 6 months
measure: Feasibility of intervention
timeFrame: Baseline, 2 months, 6 months
measure: Acceptability of intervention
timeFrame: Baseline, 2 months, 6 months
measure: Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score
timeFrame: Baseline, 2 months, 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Olayinka Shiyanbola, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05248347: An Efficacy of Simulator Training for Fiberbronchoscopy in Intensivists
Official title: An Efficacy of Simulator Training for Fiberbronchoscopy in Intensivists
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Simulator Training
Keywords: Fiberbronchoscopy
Simulation
Assessment
Validity
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: We evaluated the effects of different fiberbronchoscopy training in how to teach and assess performance. Resident participants with no experience of fiberbronchoscopy, and doctors with little clinical experience with fiberbronchoscopy were eligible for the study.

Detailed description: Participants who passed the theory test were enrolled in the study, and two training simulators for fiberbronchoscopy were used. After randomization, participants were enrolled in Group A (Bronchoscopy training simulator LM-092 )and Group B(The BRONCH Mentor). The test will be taken after practice at the appropriate time.

Eligibility criteria: Inclusion Criteria:

Doctors with little experience of fiberbronchoscopy

Exclusion Criteria:

* Resident participants who can not complete the study.
* Resident participants who can not pass the theroy examination.

Primary outcomes:
measure: Final score for examination by Bronchoscopy training simulator
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: % time at mid-lumen for fiberbronchoscopy manipulation by Bronchoscopy training simulator
timeFrame: through study completion, an average of 3 months
measure: % time at mid-lumen
timeFrame: through study completion, an average of 3 months
measure: % time at mid-lumen for fiberbronchoscopy manipulation
timeFrame: through study completion, an average of 3 months
measure: Total wall hits for fiberbronchoscopy manipulation by Bronchoscopy training simulator
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Jingyuan Xu, M.D.
role: STUDY_DIRECTOR
References: