louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02818803: Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic
Official title: Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic in Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candidiasis, Oral
Stomatitis, Denture
Keywords: propolis
therapeutic
miconazole
denture stomatitis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Financiadora de Estudos e Projetos
First posted: 2016-06-30
Enrollment: 40
Sex: ALL
Minimum age (years): 60
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 evaluate the efficacy and safety of propolis on the treatment of oral candidiasis, more specifically denture stomatitis. Half of participants will receive a standardized-propolis (EPP-AF®) gel formulation while the other half will receive miconazole gel, both for oral use.


Eligibility criteria: Inclusion Criteria:

* Elderly patients with denture stomatitis

Exclusion Criteria:

* Recent use of anti fungals or antibiotics(2 months or less), dementia

Primary outcomes:
measure: Change from Newton Score at 14 days
timeFrame: Day 14
Secondary outcomes:
measure: Assessment of gel acceptability
timeFrame: Day 7
measure: Assessment of adverse events
timeFrame: Day 7 and 14
measure: Anti fungal activity
timeFrame: Day 1 and 14
Other outcomes:
Locations:
city: Anapolis
country: Brazil
facility: Unievangelica Anapolis
state: Goias
city: Ribeirao Preto
country: Brazil
facility: Unidade de Pesquisa Clinica HCRP-USP
state: São Paulo
Study officials:
affiliation: Faculdade de Medicina de Ribeirão Preto/USP
name: Erica N Lia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unievangelica Anapolis
name: Gisela M Pina, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freires IA, Queiroz VCPP, Furletti VF, Ikegaki M, de Alencar SM, Duarte MCT, Rosalen PL. Chemical composition and antifungal potential of Brazilian propolis against Candida spp. J Mycol Med. 2016 Jun;26(2):122-132. doi: 10.1016/j.mycmed.2016.01.003. Epub 2016 Feb 23.
citation: Santos VR, Gomes RT, de Mesquita RA, de Moura MD, Franca EC, de Aguiar EG, Naves MD, Abreu JA, Abreu SR. Efficacy of Brazilian propolis gel for the management of denture stomatitis: a pilot study. Phytother Res. 2008 Nov;22(11):1544-7. doi: 10.1002/ptr.2541.
citation: Santos VR, Pimenta FJ, Aguiar MC, do Carmo MA, Naves MD, Mesquita RA. Oral candidiasis treatment with Brazilian ethanol propolis extract. Phytother Res. 2005 Jul;19(7):652-4. doi: 10.1002/ptr.1715.
Clinical trial NCT03614403: The Effect of Vitamin D3 on Postoperative Pain in Patients Undergoing Craniotomy
Official title: The Effect of Single High Dose of Vitamin D3 on Short-term Postoperative Pain in Patients Under Craniotomy for Brain Tumor Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Neoplasms
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D is a hormone mainly synthesized in the skin in the presence of sunlight. Like other hormones, vitamin D plays a role in a wide range of processes in the body. Some studies have shown vitamin D has anti-inflammatory effects in the body by reducing the release of pro-inflammatory cytokines and suppressing T-cell responses. Therefore, vitamin D may be effective on reduce pain by such mechanisms. In this trial patients with brain tumor under craniotomy will receive a single high dose vitamin D compared to the control group.

Detailed description: A randomized, double blind, controlled trial will be conducted in intensive care unit (ICU) and neurosurgery ward, in Shohada-E-Tajrish hospital,Tehran, Iran. First, patients will be carefully checked for inclusion and exclusion criteria. Then, the eligible patients will complete the consent form for this study. 60 eligible brain tumor patients diagnosed by surgeon that are ready for craniotomy will be selected.These patients will be divided into two groups. Intervention group will be received an intramuscular (IM) single dose of vitamin D (300000 IU),while another group will not receive. Pain in patients will be checked daily by up to 3 days after surgery. Finally, the VAS pain score will be compared in both groups.

Eligibility criteria: Inclusion Criteria:

* Written informed consent of patient or legal representative
* 25(OH)D level below 20ng/dL

Exclusion Criteria:

* Other trial participation, including previous participation in the pilot trial
* Pregnant or lactating women
* Hypercalcemia
* Hyperphosphatemia
* Tuberculosis
* Sarcoidosis
* History of nephrolithiasis
* History of hyperparathyroidism
* Medications that interfere with vitamin D metabolism
* Renal Insufficiency

Primary outcomes:
measure: Short-term postoperative pain: measured by the visual analogue scale or visual analog scale (VAS) that is a pain rating scale
timeFrame: Up to three days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
Study officials:
affiliation: Faculty of Nutrition and Food Technology,
name: Zahra Vahdat Shariatpanahi, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04664803: Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis
Official title: A Clinical Trial to Re-confirm the Efficacy and the Safety of Cefetamet Pivoxil Formulation in Sinusitis Patients: Double Blinded, Randomized, Parallel Designed, Multi-center, Active Comparator Study (CASIS Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Sinusitis
Lead sponsor: Korea United Pharm. Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-11
Enrollment: 284
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, double-blind, randomized, active controlled, parallel group phase 4 clinical trial to re-confirm the efficacy and safety of cefetamet pivoxil formulation in sinusitis patients

Detailed description: Patients with acute sinusitis were randomly assigned (1:1) to receive either cefetamet (500 mg twice daily, study group) or cefdinir (100 mg three times a day, control group) and corresponding placebo t.i.d. or b.i.d. for 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with sinusitis (accompanied with otitis media) at screening, and whose first symptoms occurred within the past 3 weeks
* Symptoms or signs of acute sinusitis persist without improvement for 10 days after onset or symptoms or signs of acute sinusitis initially improve and then worsen within 10 days

Exclusion Criteria:

* Those who have a history of hypersensitivity to cephalosporin, penicillin, or other beta-lactam antibiotics
* Those with a history of allergic rhinitis or other rhinitis
* Those who have been diagnosed with sinusitis more than 3 times within a year
* Have had or scheduled sinus surgery within 1 month
* Creatinine Clearance \< 40 mL/min at screening
* Those whose AST, ALT, and total bilirubin are more than 3 times the upper limit of normal at screening
* Cystic fibrosis patients

Primary outcomes:
measure: Clinical effective rate
timeFrame: 21 days
Secondary outcomes:
measure: Clinical cure rate
timeFrame: 21 days
measure: Clinical effective rate
timeFrame: 14 days
measure: Change from baseline in total score of clinical signs
timeFrame: 14 days
measure: Change from baseline in total score of clinical signs
timeFrame: 21 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06551103: The Effect of Training Given to Patients With COPD in Line With Pender's Health Promotion Model
Official title: The Effect of Training Given to Patients With COPD in Line With Pender's Health Promotion Model on Self-Efficacy Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Self Efficacy
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted as a randomized controlled experimental study. The study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. The study was terminated with the participation of 140 patients, 70 in each group. Data were collected with Descriptive Information Form and COPD Self-Efficacy Scale.

Detailed description: This study was conducted as a randomized controlled experimental study. The study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. The study was terminated with the participation of 140 patients, 70 in each group. Data were collected with the Descriptive Information Form and COPD Self-Efficacy Scale. Self-efficacy of all patients was assessed at the beginning of the study. Patients in the intervention group were given training prepared in line with the health promotion model. The control group received standard practices of the clinic. After three months, patients' self-efficacy was re-evaluated.

Eligibility criteria: Inclusion Criteria:

* being 18 years of age or older,
* having been diagnosed with COPD at least 6 months ago,
* volunteering to participate in the study,
* being able to speak and understand Turkish and communicate effectively,
* not having a mental or physical disability that would prevent answering the questions.

Exclusion Criteria:

* having a psychiatric illness,
* having vision and hearing problems,
* having cognitive dysfunction,
* not volunteering to participate in the study.

Primary outcomes:
measure: Self-Efficacy
timeFrame: 3 months after the first test
Secondary outcomes:
Other outcomes:
Locations:
city: Talas
country: Turkey
facility: Sevda Korkut
state: Kayseri
Study officials:
affiliation: TC Erciyes University
name: SEVDA KORKUT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01557803: Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome
Official title: Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome in Lambaréné, Gabon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Reconstitution Inflammatory Syndrome
Opportunistic Infections
Keywords: Immune reconstitution inflammatory syndrome
Biomarkers
HIV
ART
predictive factors
epidemiological pattern
Gabon
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
name: Albert Schweitzer Hospital
First posted: 2012-03-20
Enrollment: 107
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: Adult HIV patients starting anti retroviral therapy for the first time

Brief summary: The objective of this project is to determine clinical and biological predictors of Immune Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of this syndrome. The investigators will prospectively study HIV infected patients in Sub Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its different appearances. In these patients, the investigators will assess the value of clinical features and plasma biomarkers to predict IRIS, and the investigators will obtain insight into which inflammatory pathways become activated during IRIS. This project will provide novel knowledge about this clinically highly relevant healthcare problem in a resource poor setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will be described. Promising putative plasma biomarkers will be validated for their use in daily practice.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Informed consent
* ART naive

Exclusion Criteria:

* No informed consent
* History of ART use
* Pregnancy

Primary outcomes:
measure: IRIS
timeFrame: 12 months
Secondary outcomes:
measure: Time to IRIS
timeFrame: 12 months
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Medical Research Unit - Albert Schweitzer Hospital
state: Moyen Ogoué
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: MP Grobusch, MD, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT06061003: 3D Resin Printed Fracture Models for Anatomy Education
Official title: Can High Resolution 3D Resin Printed Models be Used in Clinical Anatomy Education for Fracture Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Educational Problems
Anatomical Pathological Condition
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups as intervention and control groups. Assessments will be performed before intervention, and after the theorical/practical lectures.
Primary purpose: OTHER

Brief summary: Resin printing is an emerging technology with a wide array of applications. This research seeks to assess the practicality of incorporating 3D resin printed models into anatomy education while investigating how fractured models impact students' decision-making and quiz scores.

Detailed description: Over the past decade, 3D printing has become increasingly accessible and cost-effective, offering systems and materials suitable for home use. 3D printing is a technology that streamlines production by translating computer-generated models into physical objects, layer by layer. In comparison to other tissue engineering and rapid prototyping methods, 3D printing boasts numerous advantages, such as exceptional precision, rapid production, cost-effectiveness, and seamless integration. Utilizing 3D models can significantly enhance the comprehension of intricate structures for medical professionals and students alike. Common materials used in 3D printing include robust nylon, aluminum, gypsum, textile components, polylactic acid, and resin. Among these, photosensitive resin stands out, as it enables the creation of higher-quality, more intricate structures that closely resemble real tissues, offering a smoother finish devoid of visible raw material textures.

This study's primary objective was to assess the suitability of tissues produced by a 3D resin printer in anatomy education, with the aim of enhancing hands-on training through direct manipulation of fractured bone models.

Eligibility criteria: Inclusion Criteria:

* having stereopsis above 40 arc/seconds according to the Titmus Stereopsis Test

Exclusion Criteria:

* having partial or total vision loss
* having a history of traumatic injury to the upper extremities within the last six months
* having used wrist anatomy models in virtual or real environments

Primary outcomes:
measure: Clinical Test
timeFrame: one hour
Secondary outcomes:
measure: Academic Motivation
timeFrame: one hour
measure: Test Anxiety Inventory
timeFrame: one hour
measure: Enjoyment and Ease of Use Assessment
timeFrame: one hour
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
state: Merkez
Study officials:
affiliation: Abant Izzet Baysal University
name: Ramazan Kurul
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06869603: Evaluation of Adherence to the Mediterranean Diet in Patients with Recurrent Renal Stones and Disease Osteometabolic
Official title: Evaluation of Adherence to the Mediterranean Diet in Patients with Recurrent Renal Stones and Disease Osteometabolic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Stones
Osteometabolic Disease
Lead sponsor: IRCCS SYNLAB SDN
Sponsor class: OTHER
Collaborators: name: Department of Clinical Medicine and Surgery - University of Naples Federico II
First posted: 2025-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with idiopathic relapsing nephrolithiasis with evidence instrumental of bilateral renal stones or emission of more than one stone in the past 5 years

Brief summary: The aim of this research protocol is to evaluate the adherence to the Mediterranean diet in patients suffering from recurrent kidney stones and osteometabolic diseases. Results of the study will allow to assess the dietary habits of patients with the above diseases. Given the universal prevalence of nephrolithiasis and osteometabolic diseases, the knowledge of these data appears crucial for the proper management of the dietary approach to prophylaxis secondar


Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic relapsing nephrolithiasis with evidence instrumental of bilateral renal stones or emission of more than one stone in the past 5 years

Exclusion Criteria:

* Patients who had albumin-corrected plasma calcium levels \> 11.0 mg/dl at the time of the first determination of serum levels of 25 OH vitamin D;
* Patients who had glomerular filtration rate \< 60 mL/min/1.73 m2;
* Patients who had positive personal history of chronic granulomatous disease;
* pregnancy patients;
* Positive personal history for morphological abnormalities of the excretory system;
* incomplete data collection.

Primary outcomes:
measure: Patient eating habits
timeFrame: 1-36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Irccs Synlab Sdn
Study officials:
References:
Clinical trial NCT04965103: Superior Capsule vs Bridging Study
Official title: Graft Reconstruction for Irreparable Rotator Cuff Tears: Superior Capsule Reconstruction or Tendon Repair With Graft Interposition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: irreparable
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Worker's Compensation Board of Alberta (funding)
name: Canadian Orthopaedic Foundation (funding)
name: Arthroscopy Association of North America (funding)
First posted: 2021-07-16
Enrollment: 50
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: Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in "irreparable" rotator cuff tears.

Detailed description: RCT n = 50

Groups:

1. bridging
2. SCR

Outcomes:

1. WORC
2. ASES
3. QuickDASH
4. MRI at 12 months post-op

Eligibility criteria: Inclusion Criteria:

1. Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively)
2. Either primary tear or re-tear after previous repair
3. Radiographic evidence of Hamada stage 1-3, with or without Samilson \& Prieto mild osteoarthritis (\<3mm inferior osteophyte)

Exclusion Criteria:

1. Primary glenohumeral osteoarthritis: radiographic evidence of Samilson \& Prieto classification moderate or greater
2. Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above
3. Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis)
4. Medical issues precluding surgery
5. Unwilling or unable to complete study outcomes
6. Worker's Compensation Claim or litigation

Primary outcomes:
measure: American Shoulder and Elbow Surgeon Outcome - patient portion
timeFrame: 24 months
measure: American Shoulder and Elbow Surgeon Outcome - patient portion
timeFrame: 12 months
measure: American Shoulder and Elbow Surgeon Outcome - patient portion
timeFrame: 6 months
measure: American Shoulder and Elbow Surgeon Outcome - patient portion
timeFrame: 3 months
Secondary outcomes:
measure: Western Ontario Rotator Cuff Index
timeFrame: 24 months
measure: Western Ontario Rotator Cuff Index
timeFrame: 12 months
measure: Western Ontario Rotator Cuff Index
timeFrame: 6 months
measure: Western Ontario Rotator Cuff Index
timeFrame: 3 months
measure: Disabilities of the Arm, Shoulder and Hand - QuickDASH
timeFrame: 24 months
measure: Disabilities of the Arm, Shoulder and Hand - QuickDASH
timeFrame: 12 months
measure: Disabilities of the Arm, Shoulder and Hand - QuickDASH
timeFrame: 6 months
measure: Disabilities of the Arm, Shoulder and Hand - QuickDASH
timeFrame: 3 months
measure: Tendon healing, assessed via MRI
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Ian Lo, MD
role: PRINCIPAL_INVESTIGATOR
References: