louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06531759: Efficacy of Fentanyl Soaked Nasal Packs on Postoperative Pain in Nasal Surgeries.
Official title: Efficacy of Fentanyl Soaked Nasal Packs on Postoperative Pain in Nasal Surgeries.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries.

Detailed description: Postoperative pain is one of the commonest feared surgical side effect which can lead to patient dissatisfaction. It occurs due to a combination of inflammatory reaction and an injury to neural tissue caused by the surgical incision. Anterior nasal packing is not an innocuous procedure. It causes discomfort/pain (especially upon removal), nasal mucosa trauma, epiphora, local infection, discomfort in swallowing, sleep disturbances and, very rarely, toxic shock and vagal reflex. Although systemic opioids are traditionally used in the management of postoperative pain, their use is still limited by their possible side effects. Opioid drugs mimic the actions of the endogenous opioid peptides by interacting with specific receptors, the opioid receptors which are μ, δ and κ. The μ receptor is important in sensory processing, including the modulation of nociceptive stimuli, extrapyramidal functioning and in limbic and neuroendrocine regulation. There are two subtypes of the μ receptor, a high-affinity μ receptor and a low-affinity μ2 receptor. Recently a third μ subtype has been described that binds opioid alkaloids such as morphine, but has essentially no, or exceedingly low, affinity for the naturally occurring endogenous opioid peptides or non-alkaloid opioids such as fentanyl. Based on the hypothesis that mu (μ) opioid receptor expression increases at the site of inflammation. our study aims to assess the analgesic effect produced by local application of fentanyl through fentanyl soaked nasal packs following different nasal surgeries.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing nasal surgeries requiring bilateral nasal packs.
2. Patients 18 years or older.

Exclusion Criteria:

1. Patients in whom fentany is contraindicated such as respiratory comorbidites (COPD and Asthma), hypersensitivity to fentanyl, liver diseases or had previous biliary tract surgeries
2. Systemic medical problems interfering with surgery.
3. Patients with traumatic conditions e.g fracture face or fracture nasal bone.
4. patients who refuse to take part in the study.
5. Patients with different nasal pathology in both sides e.g if partial turbinectomy is indicated in one side of the nose or patients with unilateral nasal polyp.

Primary outcomes:
measure: Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06474559: Comparison of Lma-Protector With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration
Official title: Comparison of Protector Laryngeal Mask With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mechanical Ventilation
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this prospective, randomized, comparative, controlled clinical study is to compare laryngeal mask airway ProtectorTM with the endotracheal tube, regarding to the respiratory mechanical parameters during controlled mechanical ventilation and the prevalence of aspiration. Aspiration will be evaluated by detecting and quantifying pepsin (a marker of gastric aspiration) and α-amylase (a marker of salivary aspiration) in the bronchoalveolar lavage ( mini BAL) of patients ≥18 years old, ASA 1-2, undergoing selective low-risk surgery under general anesthesia in a lithotomy position.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years ASA1-2 who are to undergo planned urological surgery of low or intermediate severity, under general anesthesia in the lithotomy position.

Exclusion Criteria:

* patients \< 18 years old.
* Patients who are going to undergo an emergency/urgent operation/ trauma patients.
* Maternal population.
* Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.
* Patients in whom LMA placement is contraindicated, such as patients at high risk for reflux and aspiration of gastric contents (eg, history of gastroesophageal reflux, hiatal hernia, pyloric stenosis, gastrointestinal obstruction, morbid obesity).
* Patients who meet at least one of the four RODS difficulty criteria.
* Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.
* Patients who refuse to participate in the study.

Primary outcomes:
measure: Difference in PIP cmH20 (Peak inspiratory pressure ) between the two groups of patients.
timeFrame: Intraoperative
measure: Assessment of aspiration risk by quantitative measurements of pepsin (ng/ml) and α-amylase (IU/ml) in BAL of patients and differences in its incidence between the two groups.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Differences in lung mechanics between the two patient groups
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Patras
country: Greece
facility: General Univerisity Hospital of Patras
Study officials:
References:
Clinical trial NCT02900859: Infraorbital Nerve Involvement on Magnetic Resonance Imaging in European Patients With IgG4-related Ophthalmic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orbital Inflammation
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-14
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from non-lymphoma, non-thyroid-related orbital inflammation

Brief summary: Systematic medical chart and imaging files review of patients presenting with non-lymphoma, non-thyroid-related orbital inflammation. The review aims at comparing the frequency of MRI infra-orbital nerve enlargement, between patients diagnosed with an IgG4-related ophthalmic disease (IgG4-ROD) and other patients.


Eligibility criteria: Inclusion Criteria:

* Patient suffering from acute orbital inflammation

Exclusion Criteria:

* Thyroid disease
* Lymphoma

Primary outcomes:
measure: Infra-orbital nerve enlargement on orbital MRI
timeFrame: Within 1 week following diagnosis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06913959: HIV-1 Non-group M in Cameroon : Study of Genotypic and Phylogenetic Diversity (OBSOCAM)
Official title: HIV-1 Non-group M in Cameroon : Study of Genotypic and Phylogenetic Diversity (OBSOCAM)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Infection
Keywords: HIV genetic diversity
HIV-1 non-M variants
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Rouen
name: Centre Pasteur du Cameroun
First posted: 2025-04-06
Enrollment: 220
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective phase : Dried Blood Spot samples tested positive for HIV during the Demographic health surveys in Cameroon 2011 and 2018 surveys, serotyping for HIV.

Prospective phase : Individuals who came to Center Pasteur Cameroon in Yaoundé or Garoua for HIV screening or viral load monitoring, serotyping of HIV for positive samples.

Brief summary: The aim of the study is to study the genotypic characteristics of HIV-1 non-M circulating in the whole Cameroon and their genetic evolution.

Detailed description: HIV-1 is divided four distinct groups: M (major) which represents the pandemic strains while others groups O (outlier), N (non M, non O) and P are called non-M variants. Group O (HIV-O) is more divergent, endemic in Central Africa and Cameroon, where it represents about 1% of HIV infections. These variants are characterized by an important genetic divergence from pandemic HIV-1 group M (HIV-M), which impacts on the diagnosis, monitoring and treatment of infected patients. Although discovered in 1990, and emerged at the same time as HIV-M, no data of epidemiology, natural history and evolution of the genetic diversity of these variants is currently available. The few knowledge available to date come from sporadic cases, mainly through studies in Yaoundé. It is therefore essential to improve current knowledge on these variants and their consequences on infected patients.

The aim of the study is to study the genotypic characteristics of HIV-1 non-M circulating in the whole Cameroon and their genetic evolution.

Eligibility criteria: Inclusion Criteria:

* All available samples tested positive for HIV during the national Health survey of Cameroon in 2011 And 2018
* All Individuals who came to Centre Pasteur in Yaoundé or Garoua for HIV screening or viral load monitoring.

Exclusion Criteria:

* Insufficient quantity or degraded Dried Blood Spot samples
* All HIV-positive individuals aged less than 21 years, infected with a Group M HIV-1 virus, or those who refused to participate in the study

Primary outcomes:
measure: Prevalence of non-M HIV-1 in Cameroon
timeFrame: 1 day
Secondary outcomes:
measure: Investigate the current molecular epidemiology of resistance in non-M HIV-1 variants in Cameroon
timeFrame: 1 Day
Other outcomes:
measure: Study the current molecular epidemiology of HIV 1 non-M variant resistance in Cameroon
timeFrame: 1 day
Locations:
Study officials:
References:
Clinical trial NCT05361759: National Tunisian Registry of Cardiac Implantable Electronic Devices
Official title: National Tunisian Registry of Cardiac Implantable Electronic Devices (NATURE-CIED)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Implantable Electronic Devices
Keywords: Cardiac Implantable Electronic Devices
Heart
Pacemaker
Implantable Cardioverter Defibrillator
Cardiac Loop Recorders
Biventricular Pacemakers
Heart rhythm disorder
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Tunisian Society of Cardiology and Cardiovascular Surgery
First posted: 2022-05-05
Enrollment: 1518
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: Patients undergoing cardiac implantable electronic device procedure

Brief summary: The National Tunisian Registry of Cardiac Implantable Electronic Devices is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of cardiac implantable electronic Devices in Tunisia. Cardiologists from both sectors (public and private) are participating in the study, with 26 investigational centers. Data is captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \& ICH (International Conference on Harmonisation) requirements.


Eligibility criteria: Inclusion Criteria:

* Patients originated from Tunisia
* Signed informed consent
* Patients undergoing a cardiac implantable electronic device procedure

Exclusion Criteria:

* Informed Consent not given

Primary outcomes:
measure: Incidence of patients undergoing cardiac implantable electronic devices in Tunisia
timeFrame: at inclusion
Secondary outcomes:
measure: Heart complication
timeFrame: at 12 months of follow-up
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: The Tunisian Society of Cardiology and CardioVascular Surgery
Study officials:
affiliation: Tunisian Society of Cardiology and Cardiovascular Surgery
name: Sonia Chabrak, MD
role: STUDY_CHAIR
affiliation: Tunisian Society of Cardiology and Cardiovascular Surgery
name: Abdeddayem Haggui, MD
role: STUDY_DIRECTOR
affiliation: Tunisian Society of Cardiology and Cardiovascular Surgery
name: Salma Krichène, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tunisian Society of Cardiology and Cardiovascular Surgery
name: Slim Kacem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tunisian Society of Cardiology and Cardiovascular Surgery
name: Sonia Marrakchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tunisian Society of Cardiology and Cardiovascular Surgery
name: Emna Allouche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01583075: Pulmonary Vein Ablation of Atrial Fibrillation Using Magnetic Navigation: Single Ring Versus Circumferential Techniques
Official title: Pulmonary Vein Ablation With Magnetic Navigation in Patients With Therapy-refractory Symptomatic Atrial Fibrillation: Comparison of "Single Ring" and Circumferential Ablation Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
Collaborators: name: Stereotaxis
First posted: 2012-04-23
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The single-ring ablation method aims for isolation of the posterior LA wall including the pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is unlikely.

Aim of this prospective study was to evaluate the safety and efficacy of an RMN-guided single-ring ablation method as compared to standard RMN-guided circumferential PVA.


Eligibility criteria: Inclusion Criteria:

* drug refractory AF patients undergoing PVA

Exclusion Criteria:

* drug refractory AF patients undergoing repeat PVA

Primary outcomes:
measure: Acute procedural success
timeFrame: After the end of the ablation procedure
Secondary outcomes:
measure: Long-term procedural success
timeFrame: 12 months
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: UMC Göttingen
state: Niedersachsen
Study officials:
affiliation: Clinical Electrophysiology, University Medical Center Goettingen
name: Markus Zabel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas SP, Lim TW, McCall R, Seow SC, Ross DL. Electrical isolation of the posterior left atrial wall and pulmonary veins for atrial fibrillation: feasibility of and rationale for a single-ring approach. Heart Rhythm. 2007 Jun;4(6):722-30. doi: 10.1016/j.hrthm.2007.01.034. Epub 2007 Feb 9.
Clinical trial NCT01810575: Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction
Official title: A Study to Assess the Relative Efficacy and Safety of a Single Dose of Alprostadil Cream Combined With 2 Concentrations of WC3036 Compared to Vehicle in Subjects With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Erectile Dysfunction
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 16
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety \& efficacy of a single dose of alprostadil cream with 2 concentrations of WC3036 compared to vehicle alone in men with erectile dysfunction.


Eligibility criteria: Inclusion Criteria:

* Male subject aged 40 or older of any race
* History of ED (erectile dysfunction) of at least 3 months duration defined as inability to attain \& maintain an erection of the penis sufficient to permit satisfactory sexual intercourse
* Completed and signed informed consent prior to any study related procedures

Exclusion Criteria:

* History/presence any significant disease that Investigator feels will interfere with course of the study
* Anatomic deformity of penis
* History/presence alcoholism or drug abuse/dependence within past 2 years (discretion of Investigator)
* Participation in investigational study drug trial within 30 days prior to randomization

Primary outcomes:
measure: Penile rigidity
timeFrame: Visit 1 / Up to 5 days ± 3 days
measure: Penile rigidity
timeFrame: Visit 2 / Up to 9 days ± 3 days
measure: Penile rigidity
timeFrame: Visit 3 / Up to 14 Days
Secondary outcomes:
measure: Quality of erection
timeFrame: Visit 1 / Up to 5 days ± 3 days
measure: Quality of erection
timeFrame: Visit 2 / Up to 9 days ± 3 days
measure: Quality of erection
timeFrame: Visit 3 / Up to 14 days
Other outcomes:
Locations:
city: Purchase
country: United States
facility: Warner Chilcott Investigational Study Site
state: New York
Study officials:
affiliation: Warner Chilcott
name: Vilma Sniukiene, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05681975: Immunoglobulin G4 and Immunoglobulin E Antibodies in a Population With Adverse Reactions to Foodstuffs-related Symptoms
Official title: Food-specific Immunoglobulin G4 and Immunoglobulin E Antibody Reactions in a Population With Adverse Reactions to Foodstuffs-related Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immunoglobulin E-Mediated Food Allergy
Immunoglobulin G4-Related Disease
Symptoms and Signs
Adverse Reaction to Food
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults presenting symptoms related to adverse reactions to foodstuffs and/ or with suspicion of having a food allergy or food intolerance

Brief summary: The aim of this study is to analyze a population with symptoms associated with adverse reactions to foodstuffs (ARFS). To determine the levels of food-specific immunoglobulin G4 (IgG4) and immunoglobulin E (IgE) antibody reactions (AbR).

Detailed description: Volunteers with symptoms related with adverse reactions to foodstuffs (ARFS) and suspicion of having a food allergy or a food intolerance are enrolled in this study. A 50μl of capillary whole blood is analyzed and the levels of food-specific immunoglobulin G4 (IgG4) or immunoglobulin E (IgE) antibody reactions (AbR) are determined.

Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years of age)
* To present symptoms related to adverse reactions to foodstuffs (ARFS)

Exclusion Criteria:

* Antibiotic treatment

Primary outcomes:
measure: Food-specific Immunoglobulin G4 antibody reactions
timeFrame: 0 days
Secondary outcomes:
measure: Food-specific Immunoglobulin E antibody reactions
timeFrame: 0 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politécnica de Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Lisset Pantoja-Arévalo, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03084575: Thermal Radiofrequency Versus Neurolytic Saddle Rhizotomyfor Severe Pereneal Cancer Pain
Official title: The Role of Selective Thermal Radiofrequency Saddle Rhizotomy In Managing Interactable Malignant Perineal Pain: A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Interactable Malignant Perineal Pain
Keywords: neuroaxial rhizolysis -selective rhizolysis-thermal radiofrequency
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization was done using a computer-generated random numbers with proper concealment in opaque sealed envelopes .
Primary purpose: SUPPORTIVE_CARE

Brief summary: The control of perineal malignant pain is difficult and challenging for pain physicians. Different modalities have been tried to treat this complex pain syndrome including pharmacotherapy and interventional therapy.

Neuroaxial phenol rhizolysis is simple and cheap option. However; for patients with pelvic or rectal neoplasms and intact bowel and bladder sphincteric functions, there are neurosurgical recomendations of selective sacral nerve roots rhizotomy blockade "as an alternative to chemical saddle rhizotomy".

Detailed description: 40 selected patients were randomly allocated into 2 groups "20 patients each"

Group 1 "RF group": in which patients underwent thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.

Group 2 "phenol group": in which patients underwent hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin.

Eligibility criteria: Inclusion Criteria:

* Cancer patients with moderate to severe perineal pain (VAS \> 40mm over 100 mm scale).
* Intractable pain not responding to adequate tolerated opioid therapy + adjuvant therapy after reasonable period of time for at least 4 weeks (Rad and Kallmes, 2011).
* Limited life expectancy \< 12 months (Slatakin etal 2003).
* Patients are continent to urine and stool (no stomas).

Exclusion Criteria:

* Uncorrected coagulopathy.
* Local or systemic sepsis.
* Known allergy to the used medications.
* Distorted local anatomy e.g. by advanced local neoplastic growth rendering the procedure technically difficult or hazardous.
* Sign of increased intracranial tension (Mintzer and Devarajan, 2012).

Primary outcomes:
measure: Change in VAS
timeFrame: baseline, one month, 3months
measure: Functional improvement
timeFrame: baseline, one month, 3 months
measure: Change in dose of daily drug consuption
timeFrame: base line, one month, 3 months
Secondary outcomes:
measure: ODI
timeFrame: baseline, one month, 3 months
measure: PGIC
timeFrame: baseline, one month and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute,Cairo University
name: Dina N Abbas, MD
role: PRINCIPAL_INVESTIGATOR
References: