louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05426278: The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting
Official title: The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting Among Laparoscopic Surgery Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothermia; Anesthesia
Nausea and Vomiting, Postoperative
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups will be made - One group will be interventional and the Other will be the Control group
Primary purpose: PREVENTION

Brief summary: Intraoperative Hypothermia is a common problem, our object will be to evaluate the efficacy of forced air warmer (Model # eq-5000) for maintaining core body temperature in patients undergoing laparoscopic surgeries and its effect on postoperative nausea, vomiting and shivering.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic surgeries (Hernia Repair, Cholecystectomy, Appendectomy, Hysterectomy)
* ASA Category I and II as per American Society of Anaesthesiologist Classification.
* BMI\< 35 kg/m2
* Duration of surgery \>1 hour and \<3 hours
* Patients who consent their participation

Exclusion Criteria:

* Temperature \>37.5oC or \<35oC,
* Chronic kidney disease
* Heart failure
* ASA Category 3\&4 (American Society of Anaesthesiologist Classification)
* Patients will be withdrawn from the group if their laparoscopy is converted to open surgery

Primary outcomes:
measure: Post Operative Nausea Vomiting Scale
timeFrame: Day 1
measure: Bedside Shivering Assessment Scale (BSAS)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166.
citation: Pyzocha NJ, Steele JL. Hypothermia in adults: A strategy for detection and Tx. J Fam Pract. 2018 May;67(5):E1-E7.
citation: Putzu M, Casati A, Berti M, Pagliarini G, Fanelli G. Clinical complications, monitoring and management of perioperative mild hypothermia: anesthesiological features. Acta Biomed. 2007 Dec;78(3):163-9.
citation: Liang D, Shan Y, Wang L. The effect of prophylactic rewarming on postoperative nausea and vomiting among patients undergoing laparoscopic hysterectomy: a prospective randomized clinical study. Sao Paulo Med J. 2020 Sep-Oct;138(5):414-421. doi: 10.1590/1516-3180.2020.0059.R2.06072020.
Clinical trial NCT02973178: Scanadu Urine Device Validation Study Protocol
Official title: Scanadu Urine Device Validation Study Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Tract Infections
Proteinuria
Ketone Urine
Hematuria
Glucose Intolerance
Lead sponsor: Scanadu, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will test Scanadu Urine Device for clinical performance and usability.

Detailed description: The objectives of this study are to:

* Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396).
* Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device.
* Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels

Eligibility criteria: Inclusion Criteria:

* Female and male
* 18 years old or older
* Pregnant or not pregnant
* Must have experience using an Apple iPhone
* Have no visual impairments
* Able to hold Smart Phone horizontally in raised dominant hand
* Must be able to read and understand English
* Must provide Informed Consent

Exclusion Criteria:

* Has a known history of a visual impairment that may affect reading and navigating the Scanadu Urine app
* Unable to void and collect urine specimen for testing
* Unable to hold phone steady (horizontally) or has history of tremors or conditions such as Parkinson's disease

Primary outcomes:
measure: Usability: % successful scans in three tests conducted by lay users in following the app on the iPhone and obtain user experience on questionnaire
timeFrame: Single visit in one day
measure: Method Comparison: Conduct two tests by following iPhone app (self and patient samples), results in concordance with professional testers; achieve accuracy in different concentrations of six urine analytes each using approximately 20 samples per level.
timeFrame: Single visit in one day
measure: Reproducibility: Lay user's ability to repeat a urine test nine times by following iPhone app and obtain nine results that are in concordance.
timeFrame: Single visit in one day
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: West Coast Research, LLC
state: California
city: San Leandro
country: United States
facility: West Coast Research, LLC
state: California
Study officials:
References:
Clinical trial NCT03005678: Denosumab Versus Bisphosphonates (Alendronate) in GIOP
Official title: Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: glucocorticoids, steroids, osteoporosis
Lead sponsor: Tuen Mun Hospital
Sponsor class: OTHER_GOV
First posted: 2016-12-29
Enrollment: 140
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: A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis

Detailed description: Study design: an open-label randomized controlled trial Duration of study: 12 months

Treatment arms:

1. Denosumab: a total of 2 doses in a period of 12 months
2. Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients (110 patients in each arm)

Eligibility criteria: Inclusion Criteria:

1. Adults (women or men) \>18 years of age
2. Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months).
3. Informed consent from patients.
4. Willing to comply with all study procedures

Exclusion Criteria:

1. Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.
2. Premenopausal women who plan for pregnancy within 18 months of study entry.
3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
4. Patients with unexplained hypocalcemia.
5. Patients with serum creatinine level of \>=200umol/L.

Primary outcomes:
measure: bone mineral density at lumbar spine
timeFrame: month 12
Secondary outcomes:
measure: bone mineral density at the hip
timeFrame: month 12
measure: bone turnover markers
timeFrame: month 12
measure: adverse events
timeFrame: month 12
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Medicine, Tuen Mun Hospital
Study officials:
affiliation: Principal Investigator
name: CC Mok
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03294278: Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death
Official title: Epicardial Ablation in Brugada Syndrome in the Prevention of Sudden Cardiac Death. A Randomized Prospective Follow-up Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventricular Arrhythmias and Cardiac Arrest
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1 fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs ICD only 45 patients).

Detailed description: The main purpose of this trial is to develop evidence-based curative treatment with optimal net benefit for patients with Brugada syndrome. As recent non-randomized pilot studies and scarce case reports documented the potential benefit of epicardial ablation, patients in this trial will be randomized to epicardial catheter ablation of the regions exhibiting abnormally prolonged and fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (ablation arm) or continued implanted cardioverter defibrillator therapy (control arm).

Survival from any ventricular arrhythmia (VA) recurrence will be considered as primary endpoint.

A projected 150 patients will be enrolled and randomized to receive ablation or not in a 2:1 fashion (Ablation+ICD arm 105 patients vs ICD only 45 patients).

Eligibility criteria: Inclusion Criteria:

* Patients affected by Brugada Syndrome diagnosed according to 2013 HRS/EHRA/APHRS
* Consensus document criteria
* The patient received at least 1 appropriate ICD shock.
* Documentation of any previous ventricular arrhythmia (VA) in the form of VT, non-sustained VT, non-sustained VF, RVOT PVC with a daily burden \>10000;
* Age ≥ 18;
* Willingness to attend follow-up examinations;
* Written informed consent for participation in the trial.

Exclusion Criteria:

* A patient who does not meet inclusion criteria;
* Pregnancy or breast-feeding (which would exclude an ablation procedure);
* Contraindications to general anesthesia or epicardial ablation;
* Life expectancy \< 12 months

Primary outcomes:
measure: Survival from any VA recurrence will be considered as primary endpoint
timeFrame: 2 years after ablation
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico S. Donato
state: Milano
Study officials:
affiliation: IRCCS Policlinico San Donato Milan, Italy
name: Carlo Pappone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01383278: Evaluation of a Computer-Delivered 5 A's Intervention for Smoking
Official title: Evaluation of a Computer-Delivered 5 A's Intervention for Smoking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking
Keywords: tobacco
smoking
smoking cessation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-06-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 2-group RCT in 380 tobacco-using medical patients that will compare a single session, computer-directed 5 A's intervention for smoking (experimental condition) to screening and resource provision (control condition). Follow-up visits will occur at 1 and 3 months post study enrollment. Measures will focus on tobacco use and related psychosocial outcomes (e.g. mood, stress). We will compare resources used and economic costs needed to implement each intervention.

The Investigators hypothesize that patients receiving the computer-directed intervention will have significantly higher tobacco abstinence rates at 3 months post study enrollment compared to the control group. If indeed the computerized intervention increases tobacco abstinence rates compared to the control group, this intervention could be used to increase access to treatment for the millions of US smokers, ultimately reducing tobacco mortality and morbidity rates in this country.


Eligibility criteria: Inclusion Criteria:

* 18 - 65 years
* Primary care patient
* Smoked at least one cigarette per day for the past seven days or at least 10 cigarettes total during the past week
* Smoked at least 100 cigarettes (lifetime)
* Had no recent (past 90 days) use of other forms of tobacco (pipes, cigars, NRT)
* Able to speak English

Exclusion Criteria:

- Pregnant

Primary outcomes:
measure: Tobacco use
timeFrame: 3 months post-randomization
Secondary outcomes:
measure: Mood and stress
timeFrame: 3 months post-randomization
measure: Resource utilization and economic costs
timeFrame: 3 months post-randomization
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Dace Svikis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00343278: Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets
Official title: Post-Marketing Clinical Study of Valaciclovir Hydrochloride Tablets -Single Oral Dose Study in Hemodialysis Patients-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Virus Diseases
Keywords: Valaciclovir Hydrochloride
hemodialysis patient
ALDH
pharmacokinetics
Japanese
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-22
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Valaciclovir (VACV), the L-valyl ester prodrug of aciclovir (ACV), is extensively converted to ACV and L-valine after oral administration. In subjects with normal renal function, ACV is predominantly eliminated unchanged in the urine, with a small proportion metabolized to 9-carboxymethoxymethylguanine (CMMG). The metabolism of ACV to CMMG is thought to involve aldehyde dehydrogenase (ALDH). On the basis of a high proportion of the Japanese population having low-activity ALDH, it can be hypothesized that the conversion of ACV to CMMG is decreased, thereby leading, in patients with renal impairment, to higher plasma concentrations of ACV. This pilot study was conducted to investigate potential relationships between genetic polymorphisms of ALDH2, an isozyme of ALDH, and the plasma pharmacokinetics (PK) of VACV, ACV and CMMG in subjects with end-stage renal disease on hemodialysis.


Eligibility criteria: Inclusion criteria:

* Japanese subjects with chronic renal failure undergoing hemodialysis regularly three times a week for at least 12 weeks prior to the start of the study.

Exclusion criteria:

* Subjects with current alcohol dependence.
* Subjects with gastrointestinal dysfunction that may affect drug absorption.
* Subjects who have received an organ transplant (However, subjects with a corneal transplant or any other organ transplant that may not affect the objectives of the study will be eligible for inclusion in this study).

Primary outcomes:
measure: - The pharmacokinetic parameters for VACV, ACV and CMMG - Relationship between ALDH2 genotypes and the pharmacokinetics of VACV, ACV and CMMG in blood
Secondary outcomes:
measure: - Change in blood ACV and CMMG concentrations after a 4-hour hemodialysis session - Safety (adverse events occurring during the study, clinical laboratory tests)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04277078: Predicting Intubation of Patients Hospitalised for Acutely Attacked Asthma
Official title: Predicting Factors of Intubation in Hospitalised Patients With Acutely Attacked Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation Complication
Asthma
Lead sponsor: Hat Yai Medical Education Center
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 509
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population in this study is a the patient who had been admitted with moderate to severe asthmatic attack. The study will be retrospective review with data in medical record between year 2016-2018. The baseline characteristic and factors which has a potential to intubation will be recored.

Brief summary: Although the asthmatic treatments currently be effective in term of efficacy of inhaled medications and good clinical outcome including symptom controlled and asthma exacerbation number, the large number of worse event still have been reported. Few cases eventually have been intubated and died even though using optimal medication. In this study, we will search to identify factors that may influence intubation in hospitalised patient with asthmatic attack.


Eligibility criteria: Inclusion Criteria:

* Patients who had been admitted and diagnosed as asthmatic attack between year 2016-2018.
* Patients who have age \> 15 year old.

Exclusion Criteria:

* Non

Primary outcomes:
measure: Number case of intubated patient
timeFrame: Retropectively review 2 years backard between 2017-2018
Secondary outcomes:
measure: Number of previous asthma attack before this admission
timeFrame: 1 year before admission
measure: Blood eosinophil count at admission time
timeFrame: Retropectively review 2 years backard between 2017-2018
measure: Number patients dead
timeFrame: Retropectively review 2 years backard between 2017-2018
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Hatyai Hospital
state: Songkhla
Study officials:
affiliation: HatYai Hospital
name: Narongwit Nakwan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01251978: Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
Official title: Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Choroidal Melanoma
Keywords: Choroidal melanoma
Ranibizumab
Transpupillary Thermotherapy
CSTIP
Indocyanine Green
Lead sponsor: New England Retina Associates
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-12-02
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height.
* Location of the tumor, posterior to the equator of the eye.
* Documented growth of tumor by A-B scan.
* Ability to provide written informed consent and comply with the study assessment for the full duration of the study.

Exclusion Criteria:

* Pregnancy or lactation.
* Premenopausal women not using adequate contraception.
* Current infection or inflammation in either eye.
* Extension of tumor into the orbit.
* Regional spread or metastatic disease.
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
* Any known allergy to any of the components to be used in the study.
* Participation in another simultaneous medical investigation or trial.

Primary outcomes:
measure: To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
timeFrame: 1 year
Secondary outcomes:
measure: Tumor Thickness
timeFrame: baseline and 1 year
measure: Visual Acuity (LogMar)
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamden
country: United States
facility: New England Retina Associates
state: Connecticut
Study officials:
affiliation: New England Retina Associates
name: Peter E Liggett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06359678: The Northstar Trial
Official title: Assessing the Accuracy of Catheter Localization With NorthStar Software in Real-Time MRI-Guided Cardiac Ablation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flutter, Atrial
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The introduction of real-time MRI-guided cardiac ablation therapy, a significant advancement in interventional medicine, necessitates precise catheter tracking for accurate navigation within the complex cardiac anatomy. The introduction of the NorthStar software as an active tracking system holds promise for improving the precision and efficiency of catheter manipulation during these procedures. However, a rigorous evaluation of its accuracy and reliability in a clinical setting is crucial to validate its viability.

The objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during real-time MRI-guided cardiac ablation therapy.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a real-time MRI-guided flutter ablation procedure at the Amsterdam UMC.

Exclusion Criteria:

* Lack of legal capacity.
* Insufficient proficiency in the Dutch language.

Primary outcomes:
measure: Accuracy of Catheter Localization
timeFrame: during procedure
Secondary outcomes:
measure: Influences of breathing pattern
timeFrame: during procedure
measure: Influences of procedure duration
timeFrame: during procedure
measure: Influences of complications during ablation
timeFrame: during procedure
measure: Influences of patient characteristics
timeFrame: during procedure
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
Study officials:
References: