louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04410588: Effect of Fentanyl With Topical Levobupivacaine With Nasal Packing in Endoscopic Nasal Surgery
Official title: Effect of Fentanyl With Topical Levobupivacaine With Nasal Packing in Endoscopic Nasal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Analgesia During Removal of Nasal Pack After Nasal Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the Investigators aim to study the effect of fentanyl with topical levobupivacaine with nasal packing in endoscopic nasal surgery


Eligibility criteria: Inclusion Criteria:1. All patients in the age of 18-60 year 2. ASA I-II 3. Undergoing elective nasal endoscopic surgery

-

Exclusion Criteria:

1. Patients will also be excluded if any perioperative cardiovascular or respiratory event occurred which the anaesthetist with clinical responsibility for the patient thought would make the study intervention clinically unacceptable.
2. unsatisfactory preoperative peripheral arterial oxygen saturation.
3. Unsatisfactory preoperative hemoglobin level.
4. Neurological or psychiatric disease.

Primary outcomes:
measure: postoperative pain by visual analoge score
timeFrame: 24 houres postoperative pain assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Wael
state: Asyut
Study officials:
References:
Clinical trial NCT03594188: Effects of Anesthetic Methods on Hepatic Cancer Cell Malignancy
Official title: Effects of Serum From Hepatocellular Carcinoma Surgery Patients Under Different Anesthetic Methods on Hepatic Cancer Cell Malignancy in Vitro
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Numerous studies found that anesthetic methods can influence the recurrence of tumor and the overall survival of patients after primary cancer surgery. Radiofrequency (RF) ablation is now widely used in clinic for treatment of hepatocellular carcinoma (HCC). Currently, diverse anesthetic methods, including general anesthesia (GA), epidural anesthesia and local anesthesia (LA), are used for RF ablation surgery. Using serum from HCC surgery patients randomized to receive either GA or LA during surgery, we investigated the effects of anesthetic methods on proliferation, migration and metastasis in HepG2 hepatic cancer cells in vitro.


Eligibility criteria: Inclusion Criteria:

* patients with a single primary liver tumor of 3cm or smaller, who are scheduled for RF ablation surgery

Exclusion Criteria:

* less than 18 or more than 65 years old;
* ASA Physical Status 4 or greater;
* previous surgery in liver (including radiofrequency ablation);
* severe systemic disease (heart, lung, kidney, or immune system);
* INR\>1.5 or platelet count \<45,000 cells/mm3;
* a history of addiction to opioids;
* with known extension beyond the liver;
* Child-Pugh Class C.

Primary outcomes:
measure: cell proliferation
timeFrame: 1 hour post-surgery
Secondary outcomes:
measure: cell migration
timeFrame: 1 hour post-surgery
measure: cell metastasis
timeFrame: 1 hour post-surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT04170088: Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma
Official title: Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma; a Split Face Study in Tertiary Care Hospital of Karachi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Effect of Drugs
Adverse Effects of Medical Drugs
Keywords: Melasma
Tranexamic acid
Mesotherapy
Lead sponsor: Jinnah Postgraduate Medical Centre
Sponsor class: OTHER_GOV
First posted: 2019-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: individual patients were selected in study . To control over confounding factors two sides of same patient were used parallel for intradermal injection ( Mesotherapy) of tranexamic acid and with normal saline
Primary purpose: TREATMENT

Brief summary: It is a randomized controlled trial in which investigators determine the efficacy of tranexamic acid (TA) by mesotherapy in comparison to normal saline on participants having Melasma.

Detailed description: In this prospective single blind split face controlled trial.Total 30 patients referred to Dermatology Ward were selected. At first, patients were examined under wood lamp for determination of melasma type (epidermal, dermal). Then, patients underwent Tranexamic acid microinjections with a concentration of TA 4 mg/ml with 0.9 % normal saline on their left half of the face and only 0.9%normal saline on their right half of the face, with mesotherapy technique. This procedure was done total of six times with 2-week intervals. Participants were assessed by Hemi Modified Melasma Area and Severity Scoring (mMASI) at start and end of the study for each half of face. Statistical Package for Social Sciences (SPSS) , version 23 was used for analysis. P value \< 0.01 was taken significant.

Eligibility criteria: Inclusion Criteria:

* informed consent
* age between 18 to 55 years
* bilateral symmetrical mild to severe melasma

Exclusion Criteria:

* pregnancy and lactation
* history of taken any topical treatment for melasma in previous 1 month
* history of bleeding disorders
* concomitant use of anticoagulants,
* any known drug allergy especially to the study drug,
* having associated medical illnesses.

Primary outcomes:
measure: Change in HEMI-Modified Melasma Area and Severity Index (mMASI)
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Jinnah potgraduate Medical Centre ( JINNAH HOPITAL)
state: Sindh
Study officials:
affiliation: Assistant Profesor
name: rabia ghafoor, FCPS
role: STUDY_DIRECTOR
References:
citation: Ogbechie-Godec OA, Elbuluk N. Melasma: an Up-to-Date Comprehensive Review. Dermatol Ther (Heidelb). 2017 Sep;7(3):305-318. doi: 10.1007/s13555-017-0194-1. Epub 2017 Jul 19.
citation: Handel AC, Miot LD, Miot HA. Melasma: a clinical and epidemiological review. An Bras Dermatol. 2014 Sep-Oct;89(5):771-82. doi: 10.1590/abd1806-4841.20143063.
Clinical trial NCT00511888: Nebivolol Versus Carvedilol in Patients With Heart Failure
Official title: Effects of Nebivolol Versus Carvedilol in Hypertensive Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Heart Failure
Hypertension
Keywords: chronic heart failure
hypertension
beta blockers
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2007-08-06
Enrollment: 160
Sex: ALL
Minimum age (years): 53
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: BACKGROUND Beta-blockers improve left ventricular (LV) systolic function and prognosis in patients with chronic heart failure. Both carvedilol and nebivolol have hemodynamic and clinical benefits in chronic heart failure (CHF), but it is unknown whether their pleiotropic properties may play a role in different subgroups of patients with CHF.

OBJECTIVE: To compare the effects of nebivolol and carvedilol on LV function and clinical outcome in patients with chronic heart failure and reduced LV systolic function.

METHODS: 160 hypertensive CHF patients, LV ejection fraction (EF) 40% and in New York Heart Association (NYHA) functional class II or III were randomly assigned to receive carvedilol or nebivolol therapy for 24 months. At baseline and after 24 months of treatment, all patients underwent clinical evaluation: echocardiogram and 6-minute walking test.


Eligibility criteria: Inclusion Criteria:

* left ventricular ejection fraction (LVEF) \< 40%;
* symptomatic heart failure with functional New York Heart Association (NYHA) class II or III;
* arterial hypertension with systolic blood pressure \>140 mmHg and diastolic blood pressure \>85 mmHg;
* clinical stability without hospital admission for heart failure in the previous 3 months.

Exclusion Criteria:

* history of asthma or severe chronic obstructive pulmonary disease;
* severe liver or kidney diseases;
* second-degree or third degree heart block without a permanent pacemaker,
* sick sinus syndrome, heart rate \<60 beat/min, systolic blood pressure \<90 mmHg.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: IRCCS san Raffaele Cardiovascular Research Unit
name: giuseppe rosano, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT04102488: Simplifying the World Health Organization (WHO) Protocol for Hand Hygiene: Three Steps and 15 Seconds
Official title: Simplifying Hand Hygiene Technique: Six Steps and 30 Seconds Versus Six Steps and 15 Seconds Versus Three Steps and 30 Seconds Versus Three Steps and 15 Seconds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Hygiene
Keywords: reduction of bacterial counts
hand hygiene technique
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two different hand hygiene techniques (six steps and three steps) and two different application times for hand rub (30 seconds and 15 seconds)
Primary purpose: SCREENING

Brief summary: This study is to investigate that non-inferiority in terms of reduction of bacterial counts will be retained when combining the simpler three-step technique for the use of hand rub with a shorter application time of 15 seconds.

Detailed description: The WHO guideline recommends 30 seconds for application of hand rub, however, mean bacterial reduction after 15 seconds of hand rubbing has been recently shown to be non-inferior and shortening application time to 15 seconds has been suggested to improve the frequency of hand hygiene actions in a neonatal care unit. This study is to investigate that non-inferiority in terms of reduction of bacterial counts will be retained when combining the simpler three-step technique for the use of hand rub with a shorter application time of 15 seconds.

Eligibility criteria: Inclusion Criteria:

* Medical students are eligible for participation
* Signed informed consent

Exclusion Criteria:

* No signed informed consent

Primary outcomes:
measure: Change of bacterial counts on hands
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Division of Infectious Diseases and Hospital Epidemiology
Study officials:
affiliation: University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
name: Andreas Widmer, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00349388: Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients
Official title: A Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Mesalamine
Ulcerative Colitis
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2006-07-07
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether once a day administration of Mesalamine is at least as safe and efficacious and administration of multiple doses a day in preventing clinical relapse of ulcerative colitis in children and adolescence.

Detailed description: Is taking total dose in mg/kg once a day, as safe as taking total dose divided in mg/kg spreadout during the day in preventing clinical relapse of ulcerative colitis in children and adolescence.

Eligibility criteria: Inclusion Criteria:

* Ages 6 to 18 years,
* Must be able to swallow tablets, and
* Biopsy proven ulcerative colitis

Exclusion Criteria:

* Allergy or hypersensitivity to Mesalamine or other salicylates
* Use of rectal medications

Primary outcomes:
measure: Once Daily Dosing Works as Well a Multiple Dosing a Day.
timeFrame: overall study
Secondary outcomes:
measure: Improved Medication Compliance.
timeFrame: overall study
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Memorial Hospital/Goyerb Children's Hospital
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Joel Rosh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06156488: Transcriptome Analysis of Human Bone Regeneration After Using an Anorganic Bovine Bone Graft With or Without a Combination of Polynucleotides and Hyaluronic Acid
Official title: Transcriptome Analysis of Human Bone Regeneration After Using an Anorganic Bovine Bone Graft With or Without a Combination of Polynucleotides and Hyaluronic Acid
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sinus Floor Augmentation
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 5
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 goal of this clinical trial is to compare the expression of multiple genes related to bone regeneration in maxillary bone after being grafted with a commonly used biomaterial supplemented or not with a combination of hyaluronic acid and polynucleotides.


Eligibility criteria: Inclusion Criteria:

* Partially edentulous patients.
* Kennedy class I in the upper jaw.
* Less than 5 mm of residual crestal bone to the maxillary sinus.
* Need for the replacement of teeth with dental implants.

Exclusion Criteria:

* Sinus pathology (sinusitis, mucocele, cysts).
* Smokers.
* Previous long-term (\&gt;3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.

Primary outcomes:
measure: Transcriptome analysis
timeFrame: 6 months
Secondary outcomes:
measure: Sinus floor height change
timeFrame: 6 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Universidad de Granada
Study officials:
References:
citation: Galindo-Moreno P, Abril-Garcia D, Carrillo-Galvez AB, Zurita F, Martin-Morales N, O'Valle F, Padial-Molina M. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial. Clin Oral Implants Res. 2022 May;33(5):524-536. doi: 10.1111/clr.13912. Epub 2022 Mar 3.
citation: Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernandez-Barbero JE, Ata-Ali J, O Valle F. Histopathological comparison of healing after maxillary sinus augmentation using xenograft mixed with autogenous bone versus allograft mixed with autogenous bone. Clin Oral Implants Res. 2018 Feb;29(2):192-201. doi: 10.1111/clr.13098. Epub 2017 Oct 26.
Clinical trial NCT04882488: Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis
Official title: Correlation of FFR and iFR With Cardiac PET Perfusion (at Rest and Under Adenosine) in the Evaluation of Intermediate Coronary Stenoses in Patients With Severe Aortic Valve Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Coronary Artery Disease
Keywords: Aortic valve stenosis
PET-CT
coronary artery disease
FFR
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe aortic Stenosis eligible for transcatheter aortic Valve Implantation (TAVI) with concurring coronary artery disease.

Brief summary: Aortic valve stenosis (AS) affects 2-7% of persons \> 65 years, symptoms include: angina and dyspnea, dizziness and syncope. Coincidence of coronary artery disease (CAD), also presenting with angina and dyspnea, in patients with AS between 40 - 65% . Angina in AS caused by significant reduction of coronary flow reserve (CFR). CFR is the ratio of maximal flow increase in the coronary vessel bed during maximal hyperaemia (medically or exercise induced). FFR (fractional flow reserve) use in patients with AS potentially invalid due to dysfunctional CFR leading to potential undertreatment of CAD in these patients.CFR disturbance in AS mainly due to myocardial overload causing concentric hypertrophy, increased oxygen consumption and neurohormonal activation leading to increased vascular resistance. Current studies are investigating the validity of FFR and iFR in AS patients. Recent data demonstrate very good correlation between FFR and iFR derived values to PET myocardial perfusion imaging values in patients with no evidence of AS. Our study aims to investigate the diagnostic performance of FFR and iFR in intermediate-grade coronary stenosis in patients with severe aortic valve disease and correlate FFR- and iFR derived values with those extracted from PET-perfusion Imaging.


Eligibility criteria: Inclusion Criteria:

* patients with severe aortic Stenosis eligible for transcatheter aortic stenosis
* left ventricular ejection fraction \> 55%
* no intolerance of Adenosin
* no history of bradycardia, atrioventricular Blockade
* intermediate coronary Stenosis with FFR\> 0.8
* Age \>65

Exclusion Criteria:

* intolerance of Adenosin
* left ventricular ejection fraction \< 55%

Primary outcomes:
measure: Correlation of PET-CT Prior to TAVI and 3 months after TAVI procedure
timeFrame: 3 months
Secondary outcomes:
measure: Clinical Evaluation Prior to and following TAVI
timeFrame: 3 months
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum, NRW
state: NRW
Study officials:
affiliation: Consultant physician
name: Tanja Rudolph, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04812288: Oxygenation and Muscle Function's Relationship During SLIE in Older Adults
Official title: Oxygenation and Muscle Function's Relationship During Short Light-Intensity Exercise in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygenation
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults aged 60 and over were included.

Brief summary: This study is to determine the correlations between oxygenation of calf muscles and physical performance including balance, gait speed, and endurance in older adults by utilizing the NIRS device.

Detailed description: The aim of this study is to determine the relationship between oxygenation of calf muscles and physical performance including balance, gait speed, and endurance in older adults by utilizing the NIRS device. The investigators want to determine the relationship between different types of tests and oxygenation for older adults with 4 levels of physical activity. This study will help towards identifying possible short and effective exercises for older adults with different activity levels.

Eligibility criteria: Inclusion Criteria:

* individuals who are 60 years old or older
* who are ambulatory with or without a mobility device
* can follow instructions without assistance

Exclusion Criteria:

* having an amputated limb
* current or uncontrolled vestibular disorders
* sensation impairment at the lower extremity
* macular degeneration disease such as glaucoma
* Parkinson's disease
* blood circulation disorders such as chronic venous insufficiency
* individuals without English proficiency

Primary outcomes:
measure: time to reach the minimum muscular oxygenation level (Only measure one time at a single time point, does not measure changes)
timeFrame: Day1
measure: recovery of muscular oxygenation (Only measure one time at a single time point, does not measure changes)
timeFrame: Day1
Secondary outcomes:
measure: time to finish the Timed Up and Go test (Only measure one time at a single time point, does not measure changes)
timeFrame: Day1
measure: Short Physical Performance Battery score (Only measure one time at a single time point, does not measure changes)
timeFrame: Day1
measure: distance finished in the 2-Minute Walking test (Only measure one time at a single time point, does not measure changes)
timeFrame: Day1
measure: the number of heel raise finished within one minute (Only measure one time at a single time point, does not measure changes)
timeFrame: Day1
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Fei Zhao, MPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00172978: Indications and Related Factors for Caesarean Delivery, 1996 to 2002.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: To study the effect of elective pain relief analgesia in labor on mode of delivery.


Eligibility criteria: Inclusion Criteria:

- women in labor

Exclusion Criteria:

* women with special conditions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
name: Hsiao-Lin Hwa, MD
role: PRINCIPAL_INVESTIGATOR
References: