louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05250492: Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery (API)
Official title: Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Prosthesis
Analgesia
PENG Block
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2022-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to intra-articular infiltration on postoperative morphine consumption during hip prosthetic surgery via the anterior minimally invasive approach under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, over 18 years old.
* Patient scheduled for anterior hip prosthesis.
* Affiliated patient or beneficiary of a social security scheme.
* Patient having been informed and having signed a free and informed consent.

Exclusion Criteria:

* Patient with a contraindication to local anesthesia.
* Patient with a high level of dependence, defined by level 1 or 2 of the Iso-Ressources Group (GIR).
* Patient participating in another clinical study.
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
* Pregnant, breastfeeding or parturient woman.
* Patient hospitalized without consent.

Primary outcomes:
measure: Postoperative morphine consumption in the postoperative care unit
timeFrame: 1 hour
Secondary outcomes:
measure: Postoperative morphine équivalent consumption at postoperative day 1
timeFrame: 1 day
Other outcomes:
Locations:
city: Lanester
country: France
facility: Jean-François Oudet
Study officials:
References:
Clinical trial NCT00358592: Comparison of Tissue Retractors During Cesarean Delivery in Obese Women
Official title: Randomized Controlled Trial of the Efficacy of the Mobius ™ Retractor in Performing Cesarean Sections in Patients With BMI ≥35kg/m2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section
Obesity
Keywords: surgical instruments
cesarean section
obesity
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Apple Medical Corporation
First posted: 2006-08-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial comparing the use of the Mobius™ retractor to the use of traditional metal retraction instruments in non-urgent cesarean deliveries of obese women. The Mobius™ retractor was designed for abdominal surgery to improve visualization of the surgical field through standard surgical incisions and is now a standard instrument used for cesarean deliveries at Thomas Jefferson University Hospital. We hypothesize that the use of the Mobius™ retractor during cesarean deliveries in obese women decreases operative time, blood loss, number of transfusions, infectious morbidity, incision length, and intra- / post-operative antiemetic and pain medication use, while increasing surgeon satisfaction.

Detailed description: The Mobius™ retractor has been used in many obese cesarean deliveries based on the theory that it provides superior visualization. There have been no clinical trials to determine if this "added" exposure offers any measurable significant benefits to justify the added cost. This study will determine if the Mobius™ retractor does provide a measurable difference in outcomes, compared to the traditional retraction instruments.

Eligibility criteria: Inclusion Criteria:

* pregnant women undergoing non-urgent cesarean delivery

Exclusion Criteria:

* women undergoing urgent cesarean delivery
* BMI \<35kg/m2
* women undergoing vaginal delivery
* positive urine drug screen or known history of methadone maintenance or substance abuse

Primary outcomes:
measure: operative time
Secondary outcomes:
measure: blood loss
measure: number of transfusions
measure: infectious morbidity
measure: incision length
measure: intra and postoperative antiemetic medication use
measure: intra and postoperative pain medication use
measure: surgeon satisfaction
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Jason K Baxter, MD, MSCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092989: Investigation of Intravenous (IV) Administration of an Approved Drug (MK-0476, Montelukast Sodium) for Acute Asthma (MK-0476-288)
Official title: A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Patients With Acute Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-29
Enrollment: 650
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate improved results of treatment for patients entering an emergency department with asthma attacks when given an investigational IV administration of an approved drug (MK-0476, montelukast sodium) in addition to approved standard treatment.


Eligibility criteria: Inclusion Criteria:

* Individuals with acute asthma

Exclusion Criteria:

* Women of child bearing age
* History of Chronic Obstructive Pulmonary Disease (COPD)

Primary outcomes:
measure: Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration
timeFrame: within the first 60 minutes after administration
Secondary outcomes:
measure: Incidence of treatment failures, amount of additional therapy[short-acting B-agonist] required, rate of FEV1 improvement, safety and tolerability
timeFrame: Duration of trial
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Camargo CA Jr, Gurner DM, Smithline HA, Chapela R, Fabbri LM, Green SA, Malice MP, Legrand C, Dass SB, Knorr BA, Reiss TF. A randomized placebo-controlled study of intravenous montelukast for the treatment of acute asthma. J Allergy Clin Immunol. 2010 Feb;125(2):374-80. doi: 10.1016/j.jaci.2009.11.015.
Clinical trial NCT01974089: Oropharyngeal Dysphagia in Patients With Community Acquired Pneumonia
Official title: Oropharyngeal Dysphagia in Patients With Community Acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Pneumonia
Keywords: Dysphagia
Community acquired pneumonia
Mortality
Rehospitalization
Lead sponsor: Regionshospital Nordjylland
Sponsor class: OTHER_GOV
First posted: 2013-11-01
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients recruited from the Department of Respiratory Medicine at North Denmeark Regional Hospital.

Brief summary: This study investigates relationship between community acquired pneumonia and oropharyngeal dysphagia in patients admitted to a department of respiratory medicine in Northern Denmark.

The endpoints will be re-hospitalisation and mortality.

Detailed description: Community acquired pneumonia (CAP) is an important cause of morbidity and mortality in elderly patients. Risk factors are many including oropharyngeal dysphagia (OD). Systematic screening of OD is recommended for at-risk popolations, however these resommandations do not specifically address elderly patients hospitalized with CAP.

In this study OD is assessed in all patients by Volume-Viscosity Swallowing Test (V-VST) The study is registered by the Danish Data Protection Authority (2008-58-0028)

Eligibility criteria: Inclusion Criteria:

* Temperature \> 38 degrees Celcius
* New infiltrate on chest x-ray
* Increased C-reactive protein (CRP)
* Either cough, dyspnea, pleuritic chest pain, expectoration, or tachypnea

Exclusion Criteria:

* patients referred from the intensive care unit
* reduced cognitive awareness if not able to able to cooperate with the assessment of oropharyngeal dysphagia

Primary outcomes:
measure: Intra Hospital Mortality
timeFrame: With in 10 days from admission
measure: 30 Day Mortality
timeFrame: 30 days after discharge
measure: Re-hospitalization
timeFrame: 30 days after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Hjørring
country: Denmark
facility: Vendsyssel Hospital
Study officials:
References:
Clinical trial NCT04229589: Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope
Official title: Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syncope
Keywords: Syncope, pacemaker, bradyarrhythmias
Lead sponsor: Azienda Ospedaliera Cardinale G. Panico
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 1364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope (proven or presumed) according current guidelines

Brief summary: Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.

Detailed description: Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope. All consecutive patients aged ≥18 years who underwent pacemaker implantation for syncope of bradyarrhythmic aetiology (proven or presumed) at participating centers from January 2010 to December 2013 were enrolled in the registry. During follow-up the occurrence of the first syncopal relapse after pacemaker implantation is recorded.

Eligibility criteria: Inclusion Criteria:

* patients undergoing pacemaker implantation for bradyarrhythmic syncope

Exclusion Criteria:

* age \<18 years

Primary outcomes:
measure: Syncopal relapse
timeFrame: march 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Tricase
country: Italy
facility: "Card. G. Panico" Hospital
state: Lecce
city: Ancona
country: Italy
facility: Federico Guerra
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Catanzaro
country: Italy
facility: AO Pugliese-Ciaccio
city: Napoli
country: Italy
facility: Monaldi Hospital
city: Novara
country: Italy
facility: AOU "Maggiore della Carità"
city: Novara
country: Italy
facility: Dell'Era Gabriele
Study officials:
References:
Clinical trial NCT01814189: Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment
Official title: Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment: a Randomized, Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine With Aura
Migraine Without Aura
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 350
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: The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine


Eligibility criteria: Inclusion Criteria:

* Patients who aged 18 to 65 years with a clinical history of migraine with or without aura (International Headache Society categories 1.1 or 1.2) for at least 1 year
* Subjects who have mean frequency of 2-8 migraine attacks per month.

Exclusion Criteria:

* Complex form of migraine, medication overuse headache, history of chronic tension-type headache, ophthalmoplegic, basilar and hemiplegic migraine
* Uncontrolled hypertension (diastolic blood pressure \>95 mm Hg or systolic blood pressure \>160 mm Hg)
* History or clinical evidence of cerebrovascular or cardiovascular disorder
* Renal impairment or dialysis dependence
* Serious illness (physical or psychiatric disorders)
* Drugs and alcohol abuse
* Pregnancy and breastfeeding
* Allergy or hypersensitivity to promethazine or triptans
* Concurrent use of ergotamine-containing drugs, monoamine oxidize inhibitors, antidepressant, lithium

Primary outcomes:
measure: Complete headache relief
timeFrame: At 2 hours after first dose
Secondary outcomes:
measure: Complete headache relief
timeFrame: At 0.5 hour, 1 hour, and 4 hours after first dose
measure: Headache improvement.
timeFrame: At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose.
measure: Using the second dose of study medications.
timeFrame: At 2-48 hours after first dose.
measure: Using rescue medication between 2 and 48 hours postdose
timeFrame: At 4-48 hours after second dose.
measure: Rate of headache recurrence
timeFrame: At 2-48 hours after first dose.
measure: Occurrence of adverse events.
timeFrame: At 4 hours after first dose.
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Department of Neurology, Emam Hossein Hospital
Study officials:
References:
Clinical trial NCT00655889: Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Interdental Papillary Insufficiency
Lead sponsor: Castle Creek Biosciences, LLC.
Sponsor class: INDUSTRY
First posted: 2008-04-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 evaluate the safety profile and the treatment effect of Isolagen TherapyTM in subjects with maxillary lesions who were treated in a previous study (IT-G-002, no NCT identification number)


Eligibility criteria: Inclusion Criteria:

* Subject must be 18-70 years of age
* Subject was treated in IT-G-002 (no NCT identification number)
* Subject has maxillary interproximal recession defects
* Natural teeth must be present on both sides of each area to be treated
* Negative pregnancy test and use of acceptable birth control (females of childbearing age)

Exclusion Criteria:

* Subjects who participated in other clinical trials within 30 days prior to enrollment
* Interproximal spaces including root grooves or furcations must not be involved
* Subjects with poor oral hygiene
* Subjects with a systemic condition, which would preclude periodontal treatment
* Subjects with acute infectious lesions in the treatment areas
* Subjects with open interproximal contact at study sites
* Subjects who must receive prophylactic antibiotics before dental procedures
* Subjects on chronic antibiotic or steroidal therapy
* Subjects with interproximal probing depths \> 3 mm around study lesions
* Subjects who smoke
* Subjects taking medications associated with the development of drug induced gingival hyperplasia
* Subjects with radiographic evidence of pathology
* Subjects with tooth mobility exceeding a score of 1
* Subjects with parafunctional habits and not wearing bite guard
* Subjects with interproximal spaces associated with teeth without an adequate zone of keratinized tissue
* Subjects where the etiology of the interproximal papillary recession has not been controlled
* Subjects who have received a crown or pontic on one or both teeth involved in the interproximal space to be treated

Primary outcomes:
measure: Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)
timeFrame: Baseline (prior to first study treatment) compared to six months after first treatment
measure: Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)
timeFrame: Baseline (prior to first study treatment) compared to six months after first treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Perio-Health Professionals, Inc.
state: Texas
Study officials:
References:
Clinical trial NCT02731989: Comparison Between the Clinical Assessment of the Undescended Testis and Its' Ultrasonographic Size
Official title: Comparison Between the Clinical Assessment of the Undescended Testis and Its' Ultrasonographic Size
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Undescended Testis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 60
Sex: MALE
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Boys operated for unilateral cryptorchism

Brief summary: In addition to the manual preoperative examination, the undescended testicle will be measured ultrasonographically. The compared data will help us to evaluate the routine need for preoperative ultrasonographic evaluation of the undescended testicle.


Eligibility criteria: Inclusion Criteria:

* Boys operated for unilateral cryptorchism

Exclusion Criteria:

* bilateral cryptorchism recurrent operation s/p inguinal operation

Primary outcomes:
measure: The difference between the testicular size estimated by the surgeon and the actual ultrasonographic size
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Centre
Study officials:
References:
Clinical trial NCT05864989: Non-Incised Papilla Flap in Deep Supraossous Defects
Official title: Non-Incised Papilla Flap With and Without Connective Tissue Graft for Management of Deep Supraossous Defects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 16
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the effectiveness of NIPSA in periodontal lesions with deep supra-alveolar defects, measuring the clinical efficacy of this flap. The non-incised papilla surgical approach (NIPSA) is a novel technique that accesses the periodontal defect from apical direction and was established with the aim of creating clinical advances compared with marginal access techniques.

The defects with a supra-alveolar components are more frequent than intrabony defects, there is very little evidence about their treatment .


Eligibility criteria: Inclusion Criteria:

* diagnosis of periodontal disease (periodontitis stage III and IV, grade A \[12\];
* non-smokers and former smokers who quit smoking at least 1 year previously
* previous treatment for periodontal disease using non-surgical periodontal treatment completion of step I and II of periodontal therapy
* compliance with periodontal maintenance and oral hygiene (FMPS at baseline ≤ 30%)
* active residual pockets (positive bleeding on probing; BoP) associated with intrabony defects that were not resolved with non-surgical treatment after 4-6 months of maintenance.
* periodontal lesions with probing depth (PD) \> 6 mm and supraalveolar defect (pre-diagnosis clinically (periodontal probe)

Exclusion Criteria:

* systemic disease contraindicating periodontal surgery,
* smokers, and
* third molars or teeth with incorrect
* endodontic or restorative treatment.

Primary outcomes:
measure: interproximal clinical attachment level gain
timeFrame: 6 MONTHS
Secondary outcomes:
measure: residual pocket depth
timeFrame: 6 MONTHS
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University- Russian University in Egypt
state: Al Qahirah
Study officials:
References:
Clinical trial NCT01361789: COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined
Official title: COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rupture of Anterior Cruciate Ligament
Keywords: Arthroscopic reconstruction
Anterior crucial ligament
Coxib
Dexamethasone
Lead sponsor: Asker & Baerum Hospital
Sponsor class: OTHER
First posted: 2011-05-27
Enrollment: 93
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: TREATMENT

Brief summary: Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID or COX-2 selective inhibitor gives better pain relief than either of the drugs used separately. The investigators group has also shown that adding dexamethasone on top of a regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest after ambulatory breast cancer surgery.

The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The investigators want to evaluate whether a selective COX-2 selective inhibitor or a glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL surgery.


Eligibility criteria: Inclusion Criteria:

* Arthroscopic reconstruction of the anterior crucial ligament (ACL)
* At least 18 years old
* ASA I + II

Exclusion Criteria:

* Known renal impairment
* Liver failure and/-or an asthmatic condition
* Pregnancy
* Breast feeding

Primary outcomes:
measure: Postoperative VAS score at rest 24 hours after surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Cumulated opioid consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Rud
country: Norway
facility: Baerum Hospital
Study officials:
affiliation: Baerum Hospital
name: Vegard Dahl, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baerum Hospital
name: Ulrich J Spreng, MD
role: PRINCIPAL_INVESTIGATOR
References: