louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05919966: The Association Between Chlorhexidine Bathing and Central Line-Associated Infections in Medical Intensive Care Units
Official title: The Association Between Chlorhexidine Bathing Every Other Day and Central Line-Associated Infections in Medical Intensive Care Units: An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Line-associated Bloodstream Infection (CLABSI)
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 6930
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Our study included all patients aged eighteen years and older who were admitted to the MICU between January 2017 and June 2022, without any exclusions based on specific disease characteristics.

Brief summary: We conducted a retrospective observational cohort study assessing the relationship between regular bathing using 2% CHG wipes every other day and the occurrence of central line-associated infections (CLABSI) in patients within the medical intensive care unit (MICU).

Detailed description: This study defined the post-intervention period as July 1, 2017, to June 30, 2022. During this period, one of the three medical intensive care units (MICUs) in NTUH implemented chlorhexidine gluconate (CHG) bathing as part of their daily care routine (CHG group). This decision was made in response to a higher incidence rate of vancomycin-resistant Enterococcus (VRE) bacteremia observed in that particular MICU during the preceding six months (pre-intervention period: January 1, 2017, to June 30, 2017), compared to the other two MICUs. The remaining two MICUs continued to provide usual care, which involved bathing patients with towels soaked in water and soap on a daily basis.

Eligibility criteria: Inclusion Criteria:

* all patients who were admitted to the MICU between January 2017 and June 2022

Exclusion Criteria:

* patients aged under 18 years old

Primary outcomes:
measure: central line-associated bloodstream infections
timeFrame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
measure: multidrug-resistant organisms bacteremia
timeFrame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
Secondary outcomes:
measure: ICU length of stay
timeFrame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
measure: hospital length of stay
timeFrame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
measure: ICU mortality
timeFrame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
measure: hospital mortality
timeFrame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Chen Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04409366: One- Versus Two-Stage Aesthetic Crown Lengthening
Official title: One- Versus Two-Stage Aesthetic Crown Lengthening for Restorative Purposes: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients in Need of Surgical CL in the Anterior Maxillary Sextant for Restorative Purposes
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial was aimed at assessing the efficacy of a two-stage crown lengthening intervention (SCL) for restorative purposes in the aesthetic zone compared with a one-stage crown lengthening procedure (CCL).

Detailed description: Subjects were randomly allocated to receive SCL or CCL. SCL consisted of full thickness flaps followed by bone recontouring and minor gingivectomy 4 months postoperatively, if required. In CCL, osseous recontouring after sub-marginal incisions was performed, followed by flap repositioning. Records were obtained at baseline, 4 months (only in SCL), 6 and 12 months. Primary outcome was the precision in achieving a predetermined gingival margin position. Other outcomes were changes in the gingival margin position and keratinized tissue width (KTW) at 12 months, and patient-reported outcomes (PROMs) using the OHIP-14 tool.

Eligibility criteria: Inclusion Criteria:

* older than eighteen years of age;
* more than 20 teeth in the mouth;
* with full mouth plaque and bleeding scores lower than 15%; and
* without probing pocket depth and/or attachment loss \>4 mm

Exclusion Criteria:

* Pregnant women or breastfeeding
* smokers
* treated with antimicrobial and/or anti-inflammatory drugs within two months prior to entering the study
* currently undergoing orthodontic therapy

Primary outcomes:
measure: T1-T4
timeFrame: Baseline-12 months
Secondary outcomes:
measure: Clinical Crown Length
timeFrame: At baseline, 6- and 12-month
measure: Amount of keratinized tissue
timeFrame: At baseline, 6- and 12-month
measure: Gingival display upon smiling
timeFrame: At baseline, 6- and 12-month
measure: Supracrestal tissue dimension
timeFrame: At baseline, 6- and 12-month
Other outcomes:
Locations:
Study officials:
References:
citation: Gonzalez-Martin O, Carbajo G, Rodrigo M, Montero E, Sanz M. One- versus two-stage crown lengthening surgical procedure for aesthetic restorative purposes: A randomized controlled trial. J Clin Periodontol. 2020 Dec;47(12):1511-1521. doi: 10.1111/jcpe.13375. Epub 2020 Oct 20.
Clinical trial NCT01055366: ELAZOP Switching Study in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open Angle Glaucoma
Keywords: Open angle glaucoma
OAG
Elazop
Azarga
Brinzolamide/Timolol combination
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-01-25
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from prior pharmacotherapy in patients with open-angled glaucoma.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
* Must be on a stable regimen of Intraocular Pressure (IOP) lowering medication (i.e., either a single therapeutic agent or two separate ocular hypotensive agents) for at least one month prior to the Screening Visit.
* Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
* Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in the study that is deemed clinically significant in the opinion of the Principal Investigator.
* Intraocular conventional surgery or laser surgery in either eye less than three months prior to the Screening visit.
* History of ocular herpes simplex.
* Pregnant or lactating.
* Participation in any other investigational study within 30 days of Screening visit.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Intraocular Pressure (IOP) change from baseline at final visit.
timeFrame: 12 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sungnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyounggi
city: Daegu
country: Korea, Republic of
facility: Youngnam Univ. Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Kangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital
city: Seoul
country: Korea, Republic of
facility: St. Mary's Hospital, The Catholic University of Korea
Study officials:
References:
Clinical trial NCT04456166: Safety of Preoperative Carbohydrate Loading in Diabetic Patients
Official title: Safety of Preoperative Carbohydrate Loading in Diabetic Patients Undergoing General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carbohydrate Intolerance
Diabetes Mellitus Type 2
Keywords: Carbohydrate Intolerance
Diabetes Mellitus
Diabetes Mellitus, Type 2
Carbohydrate loading
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over 18 years of age who are scheduled to undergo general anesthesia are subject to preoperative carbohydrodritate loading and diagnosed with type 2 diabetes taking oral hypoglycemic agents

Brief summary: The purpose of this study is to investigate the safety of preoperative carbohydrate loading in diabetic patients undergoing general anesthesia


Eligibility criteria: Inclusion Criteria:

* Elective surgery
* Type 2 diabetes mellitus on oral hypoglycemic agents
* American Society of Anesthesiologists physical status 2 or 3
* Ages 18 or more
* Approve to participate

Exclusion Criteria:

* Ambulatory surgery
* BMI \>35
* History of gastric or esophagus surgery
* History of GERD, dyspepesia or
* Anticipated difficult intubation (previous III or more Cormack and Lehane's grade, Mallamgrade, Mallampati scpati scoreore III or moreIII or more, propro/retro/retrognathism, gnathism, thyromental distance\<6.5cm, thyromental distance\<6.5cm, limited mouth openinglimited mouth opening)

Primary outcomes:
measure: Incidence of gastric ultrasonography score as low risk (grade 0 or 1)
timeFrame: 30 minutes after intubation
Secondary outcomes:
measure: Gastric volume
timeFrame: 30 minutes after intubation
measure: Blood sugar test
timeFrame: 30 minutes after intubation and 30 minutes after extubation
measure: The incidence of insulin bolus injection
timeFrame: during operation
measure: The incidence of insulin bolus injection
timeFrame: up to 30 minutes after extubation
measure: Satisfaction scale of patients
timeFrame: up to 30 minutes after extubation
measure: The incidence of nausea and vomiting
timeFrame: up to 30 minutes after extubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongnogu
Study officials:
affiliation: Seoul National University Hospital
name: Susie Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee S, Sohn JY, Lee HJ, Yoon S, Bahk JH, Kim BR. Effect of pre-operative carbohydrate loading on aspiration risk evaluated with ultrasonography in type 2 diabetes patients: a prospective observational pilot study. Sci Rep. 2022 Oct 20;12(1):17521. doi: 10.1038/s41598-022-21696-1.
Clinical trial NCT04030065: Study to Assess the Effect of Intravenous Supplementation of Omega-3 Fatty Acids on Outcome of Recipients in Living Donor Liver Transplantation
Official title: Randomized Controlled Trial to Study the Effect of Intravenous Supplementation of Omega-3 Fatty Acids on Outcome of Recipients in Living Donor Liver Transplantation (LDLT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Transplantation
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 124
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: In this study, the investigators aim to analyse the effect of Omega 3 fatty acid supplementation on recipients undergoing living donor liver transplantation. In Group A, the patients receive Omega 3 fatty acid on preoperative day 1, intraoperatively and up to day 5 post operatively; and the effect of omega 3 fatty acid supplementation on early allograft dysfunction, its correlation with occurrence of postoperative complications and liver regeneration measured by CT volumetry on Day 7. Group B, the patients are controls for the study and hence attempt to find out the effect of omega 3 fatty acid supplementation on outcome of recipients of Living donor liver transplantation. the investigators will analyse the data and elucidate the value of omega 3 fatty acid supplementation in reducing the occurrence of early allograft dysfunction , complications and effect on liver regeneration in recipients of Living donor liver transplantation.


Eligibility criteria: Inclusion Criteria:

* All elective liver transplant recipients
* Adult patients
* Those who consent

Exclusion Criteria:

* Liver transplantation for fulminant hepatic failure
* Re-transplantation
* Known allergy to the study emulsion

Primary outcomes:
measure: Early Allograft Dysfunction
timeFrame: Post operative day 7
Secondary outcomes:
measure: Liver function test - trend
timeFrame: Till period of hospital stay, average of 1 month
measure: Complications
timeFrame: Till period of hospital stay, average of 1 month
measure: ICU and hospital stay
timeFrame: Till period of hospital stay, average of 1 month
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and biliary Sciences
Study officials:
affiliation: Professor and head , Department of HPB surgery and liver Transplantation, ILBS, New Delhi
name: Viniyendra Pamecha, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04279665: Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures
Official title: Use of Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures Involving no or Minimal Sedation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arrhythmia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are assessing whether use of a virtual reality experience, used during the procedure, can reduce anxiety and improve satisfaction related to the procedure, especially when no or little sedation is being used.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing invasive EP procedures with plan for no or minimal conscious sedation

Exclusion Criteria:

* Patients unable to consent

Primary outcomes:
measure: Subject anxiety
timeFrame: 20 minutes
measure: Subject comfort
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Suraj Kapa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05528965: Parallel Versus Perpendicular Technique for Genicular Radiofrequency
Official title: Parallel Versus Perpendicular Technique for Genicular Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 60
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: Although there are different ways of performing genicular nerve radiofrequency on knee pain, to our knowledge, there is no stuies comparing the clinical outcomes of a parallel technique vs. a perpendicular technique. We aimed to compare the effectiveness of these both techniques.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Intra-articular injections in the knee during the 3 months prior to procedure
* Chronic pain syndrome
* Lumbar radicular pain
* Patients who are unwilling or mentally incapable to complete the study questionnaires.

Primary outcomes:
measure: The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS)
timeFrame: 6 months after intervention.
Secondary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 months after intervention.
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT03425565: A Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer
Official title: A Phase II Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Clear Cell Tumor
Gynecologic Cancer
Advanced Cancer
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PEACOCC is a multi-centre, single arm, single stage phase II trial. The overall aim is to determine whether treatment with pembrolizumab is effective in patients with advanced clear cell gynaecological cancer.


Eligibility criteria: Main Inclusion Criteria:

1. Histological diagnosis of advanced clear cell ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval or cervical cancer.
2. Have measurable disease based on RECIST 1.1.
3. Evidence of radiological disease progression.
4. Patient is willing to provide tissue from a newly obtained core or excisional biopsy of a tumour lesion at baseline, 6-8 weeks after start of treatment and at the time of progression.
5. ECOG Performance Status 0 or 1.
6. Patient has a life expectancy of at least 3 months from consent.
7. Received ≥ 1 line of prior chemotherapy .

Main Exclusion Criteria:

1. Has a known diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses \> 10mg prednisolone daily or equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
2. Has a known history of active TB (Bacillus Tuberculosis), Hepatitis B (e.g., HBsAg reactive), Hepatitis C or a known history of Human Immunodeficiency Virus (HIV).
3. Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids (at a dose \>10mg predisolone daily or equivalent) or immunosuppressive drugs).
5. Has known history or evidence of active, non-infectious pneumonitis.
6. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
7. Has received a live vaccine within 30 days prior to the planned start of trial treatment.

Primary outcomes:
measure: Progression Free Survival at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: Manchester
country: United Kingdom
facility: The Christie Hospital
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
References:
Clinical trial NCT06587165: Quantifying New Heart Muscle Cells
Official title: A Pilot Study for Quantifying New Heart Muscle Cells
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Tetralogy of Fallot With Pulmonary Stenosis
Heart Failure
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: California Institute of Technology
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Regenerative therapies could provide new ways of treating heart failure. Unlike many organs in the human body, such as the skin and the GI tract, the ability to regenerate heart muscle decreases after birth, but the precise timing of this decrease and how this decrease is altered in heart disease are uncertain. The investigators will use an innovative approach to quantify cellular heart regeneration in pediatric patients, an appropriate population for determining this decline as well as the potential for reactivating heart muscle regeneration.

The study has now been registered on ClinicalTrials.gov, despite its initiation on July 23, 2015, as registration was not mandated at the original study site, the University of Pittsburgh Medical Center. However, following the transfer of the study to Weill Cornell Medicine, adherence to institutional requirements necessitated its registration on ClinicalTrials.gov.


Eligibility criteria: Inclusion Criteria:

* Patients at 30 days of age to 1 year of age undergoing scheduled elective cardiac surgery will be eligible for study inclusion.
* The investigators will recruit patients at 30 days of age to 1 year of age with those types of heart disease whose surgical approach has a high probability of myocardial resection.
* Diagnosis of ToF/PS or other types of heart disease that have a high likelihood of requiring surgery that involves routine resection of myocardium that becomes available for research

Exclusion Criteria:

* Patients with low chance of having resection of myocardium as part of their surgical care.

Primary outcomes:
measure: Percentage of labeled cardiomyocytes for each patient
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Bernhard Kuhn, MD
role: PRINCIPAL_INVESTIGATOR
References: