louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02839421: Efficacy of Three Antibiotic Protocols for Aggressive Periodontitis Treatment
Official title: Efficacy of Moxifloxacin, Amoxicillin+Metronidazole for Aggressive Periodontitis Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aggressive Periodontitis
Lead sponsor: Facultad Nacional de Salud Publica
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the clinical and microbiological efficacy of moxifloxacin or amoxicillin plus metronidazole in one-stage scaling and root planing in treating generalized aggressive periodontitis. Forty five subjects will be randomly allocated to 3 treatment groups. Subgingival plaque samples will be analysed for cultivable bacteria. The primary outcome variable to determine the superiority of one treatment over the others would be differences between groups for means CAL changes at 6 months post-treatment. Secondary outcome variables include differences between therapies for the mean changes in the mean levels of PD and the proportion of BOP.


Eligibility criteria: Inclusion Criteria:

* Subjects ≤30 years of age
* minimum of six permanent teeth, with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm and a minimum of six teeth other than first molars and incisors with at least one site each with PD and CAL ≥5 mm.

Exclusion Criteria:

* diabetes
* cardiovascular diseases
* immunological disorders or any other systemic disease that could alter the course of periodontal disease.
* Pregnant or nursing women
* smoking
* allergy to amoxicillin, metronidazole, fluoroquinolones or moxifloxacin
* consumption of systemic antimicrobials or anti-inflammatory drugs in the last 6 months
* periodontal therapy during the last 6 months

Primary outcomes:
measure: clinical attachment level
timeFrame: 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Faculty of Dentistry
state: Antioquia
Study officials:
References:
citation: Hammami C, Nasri W. Antibiotics in the Treatment of Periodontitis: A Systematic Review of the Literature. Int J Dent. 2021 Nov 8;2021:6846074. doi: 10.1155/2021/6846074. eCollection 2021.
Clinical trial NCT04361864: Cross-sectional Survey on Patients With Urinary Tract Infections in Puy-de-Dôme : Epidemiology of Recurrent Urinary Tract Infections and Risk Factors
Official title: Cross-sectional Survey on Patients With Urinary Tract Infections in Puy-de-Dôme : Epidemiology of Recurrent Urinary Tract Infections and Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Caisse Primaire d'Assurance Maladie du Puy-de-Dôme
First posted: 2020-04-24
Enrollment: 561
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with at least one urinary tract infection during year 2019

Brief summary: Urinary tract infections (UTI) are an important part of infectious diseases. For some patients, those infections are recurrent and have many consequences such as altered quality of life, recurrent symptoms, antibiotics overuse... The primary purpose of this study is to estimate the proportion of patients in Puy-de-Dôme with recurrent urinary tract infections among patients with at least one UTI during 2019. The secondary purposes are : characteristics of patients with recurrent UTI, by sex ; determine predictive factors of recurrent UTI, by sex ; describe bacterial ecology of recurrent UTI and the proportion of multi-resistant bacteria.


Eligibility criteria: Inclusion Criteria:

* patient from 18 years old
* affiliated to the french healthcare system
* with at least one urinary tract infection during year 2019
* has accepted email contact with CPAM 63 (Caisse Primaire d'Assurance Maladie du Puy-de-Dôme)

Exclusion Criteria:

* pregnancy during year 2019
* none urinary tract infection reported in 2019

Primary outcomes:
measure: Proportion of recurrent urinary tract infections
timeFrame: During year 2019
Secondary outcomes:
measure: age in year
timeFrame: day 1
measure: sexe
timeFrame: day 1
measure: , medical and surgical history
timeFrame: day 1
measure: life habits
timeFrame: day 1
measure: number of visits at the general practitioner
timeFrame: during year 2019
measure: number of urinalysis
timeFrame: during year 2019
measure: number of antibiotic therapies
timeFrame: during year 2019
measure: quality of life
timeFrame: during year 2019
measure: bacteriological characteristics of recurrent urinary tract infections
timeFrame: during year 2019
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Olivier Lesens
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01516164: A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope
Official title: A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Keywords: Laryngoscopy
Videolaryngoscopy
Ease of Intubation
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
First posted: 2012-01-24
Enrollment: 158
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Videolaryngoscopes offer the potential to make tracheal intubation easier for the anaesthetist and less traumatic for the patient. This study aims to compare the intubation difficulty scores (a validated scoring system for ease of intubation) using the McGrath MAC as a videolaryngoscope, the McGrath MAC only as a direct laryngoscope (without video screen) and the MacIntosh laryngoscopes.


Eligibility criteria: Inclusion Criteria:

* Elective procedure requiring oral tracheal tube intubation
* Over 16 years of age
* Airway assessment suggests to the anaesthetist that a standard MacIntosh laryngoscope approach to intubation would be appropriate.

Exclusion Criteria:

* Emergency procedure
* Less than 16 years of age
* Unable to consent
* Requiring Rapid Sequence Induction (a specialised anaesthetic induction technique)
* Predicted difficult intubation
* Not suitable for the standardised induction technique

Primary outcomes:
measure: Intubation Difficulty Score
timeFrame: 5 minutes
Secondary outcomes:
measure: Time to intubation
timeFrame: 5 minutes
measure: Number and types of alternative techniques used
timeFrame: 5 minutes
measure: Perception of force used
timeFrame: 5 minutes
measure: Complications
timeFrame: 5 minutes
measure: Ease of intubation
timeFrame: 5 minutes
measure: Failure to intubate
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Tayside
country: United Kingdom
facility: NHS Tayside
Study officials:
affiliation: NHS Tayside
name: Claire D Wallace, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06240364: Effects of AffronEye®/ Crocuvis+® on Dry Eye Syndrome
Official title: Effects of AffronEye®/ Crocuvis+® on Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: University of Alicante
Sponsor class: OTHER
Collaborators: name: Pharmactive Biotech Products S.L.U
First posted: 2024-02-05
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Previous research has demonstrated the effectiveness of AFFRONEYE® / CROCUVIS+® dietary supplement, based on saffron extract, in the proper functioning of visual health, for example, against the development of glaucoma. The main objective of this study is to compare the results of clinical tests that evaluate signs and symptoms for the diagnosis of dry eye, between two groups (some that take the dietary supplement and others a placebo), in a sample of university workers and students who suffer from dry eye.


Eligibility criteria: Inclusion Criteria:

* Have dry eye according to the diagnostic criteria established by the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS).

Exclusion Criteria:

* Pathology of the anterior ocular surface under treatment (such as conjunctivitis, keratitis, among others).
* Take any type of dietary supplements, with or without botanical components in the last month.
* Pregnancy or breastfeeding (also excludes recent pregnancy within the last 3 months) and women planning to become pregnant.

Primary outcomes:
measure: Changes from baseline dry eye symptoms at 28, 56 and 84 days
timeFrame: 0 (baseline), 28, 56 and 84 days
measure: Changes with respect to baseline NIBUT at 28, 56 and 84 days
timeFrame: 0 (baseline), 28, 56 and 84 days
measure: Changes with respect to baseline TMH at 28, 56 and 84 days
timeFrame: 0 (baseline), 28, 56 and 84 days
measure: Changes with respect to baseline ocular surface stainings at 28, 56 and 84 days
timeFrame: 0 (baseline), 28, 56 and 84 days
measure: Changes with respect to baseline lipid layer of the tear film at 28, 56 and 84 days
timeFrame: 0 (baseline), 28, 56 and 84 days
measure: Changes with respect to baseline MGD at 28, 56 and 84 days
timeFrame: 0 (baseline), 28, 56 and 84 days
measure: Changes from baseline osmolarity at 28, 56 and 84 days
timeFrame: 0 (baseline), 28, 56 and 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Vicente Del Raspeig
country: Spain
facility: University of Alicante
state: Alicante
Study officials:
References:
Clinical trial NCT01068964: Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes
* Eye pressure lowering topical medications are not working
* Visual acuity is at least 0.2 in each eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Any other active eye disease other than glaucoma or ocular hypertension
* Significant visual field loss or evidence of progressive visual field loss within the last year
* Anticipated wearing of contact lenses during the study
* Required chronic use of other ocular medications during the study
* Eye surgery or laser treatment within 12 weeks prior to study enrollment

Primary outcomes:
measure: The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Ling Z, Zhang M, Hu Y, Yin Z, Xing Y, Fang A, Ye J, Chen X, Liu D, Wang Y, Sun W, Dong Y, Sun X. Safety and efficacy of bimatoprost/timolol fixed combination in Chinese patients with open-angle glaucoma or ocular hypertension. Chin Med J (Engl). 2014;127(5):905-10.
Clinical trial NCT06922864: the Prediction Value of Combined Electroencephalographic and Electromyographic Response in Disorders of Consciousness
Official title: the Prediction Value of Combined Electroencephalographic and Electromyographic Response in Disorders of Consciousness
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Disorders of Consciousness Due to Severe Brain Injury
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 36
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 wih disorders of consciousness in xijing hospital

Brief summary: The goal of this observation study is to learn about the prediction value of combined electroencephalographic and electromyographic response in disorders of consciousness.

The main ways of stimulation is thermal and itch. Six months after inclusion in the study, patients were classified according to the Glasgow Outcome Scale Extended, (GOSE).


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Brain damage lasts 28 to 90 days.
3. It meets the diagnostic criteria of unresponsive arousal syndrome/vegetative state (UWS/VS) or microconscious state (MCS).

   Diagnostic criteria for UWS/VS: loss of cognitive function and inability to execute commands; There is a sleep-wake cycle; Inability to understand or express language; The ability to open eyes automatically or in response to stimulation; Can be purposeless eye following movement; The functions of hypothalamus and brainstem were basically preserved.

   MCS diagnostic criteria: simple instructions can be executed; Yes/no (whether correct or not) can be expressed by gesture or speech; Have an understandable language; Purposeful behavior (including activity or emotional response) with more than one can diagnose MCS.
4. All subjects' legal guardians sign informed consent forms.

Exclusion Criteria:

1. Spinal cord T1 and above plane injury, peripheral nerve injury and so on affect nerve conduction;
2. The impact of injury on palms and soles of feet;
3. History of developmental, psychiatric, or neurological disorders prior to brain injury.
4. Deep sedation within 72 hours, including the use of general anesthesia.
5. Increased intracranial pressure, liver/kidney failure, and hemodynamic instability within 72 hours.
6. Severe co-existing systemic diseases with limited life expectancy.

Primary outcomes:
measure: the state of consciousness
timeFrame: 6 months
Secondary outcomes:
measure: the score of GOSE
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05141864: Acmella Oleracea in the Analgesia of the Digital Rectal Examination
Official title: Acmella Oleracea in the Analgesia of the Digital Rectal Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Analgesia in the Digital Rectal Examination
Keywords: Prostatic neoplasms
Digital Rectal Examination
Phytotherapy
Pain
Analgesia
Spilanthes oleracea
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 150
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to develop an herbal gel based on Acmella oleracea and do a comparative analysis to evaluate the intensity of pain during the digital rectal examination comparing to lidocaine gel group and ultrasound gel group.

Detailed description: The aim of the study is to develop an herbal gel based on Acmella oleracea and do a comparative analysis to evaluate the intensity of pain during the digital rectal examination comparing to lidocaine gel group and ultrasound gel group.

We are conducting a randomized, controlled, single-blind clinical trial of man undergoing to digital rectal examination, with 150 participants. Will be recruit at the Urologic Clinic of the Samuel Libânio Clinical Hospital and Urologic Clinic CISAMESP in Pouso Alegre. Participants divided into three groups, A. oleracea gel group, lidocaine gel group and ultrasound gel group. The digital rectal examination always performed by the same doctor, on the same position. A visual analogue scale (VAS) will be the standard method to evaluate the pain levels. The VAS will be explained to all patients, 0 = no pain and 10 = the most severe pain.

Eligibility criteria: Inclusion Criteria:

* Male patients
* Patients to agree to participate in the study

Exclusion Criteria:

* Diabetic, chronic kidney disease, with urogenital infections, using an indwelling urinary catheter, with history of anorectal diseases or surgeries, psychiatric patients and who refused to participate in the research

Primary outcomes:
measure: Evaluate the pain
timeFrame: 1 day (After the digital rectal examination)
Secondary outcomes:
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Universidade do Vale do Sapucaí
state: Minas Gerais
Study officials:
affiliation: Vale do Sapucaí University
name: Fabrizia S Guerrieri
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02202564: Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cancer
Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
liver transplantation
adenovirus-thymidine kinase
gene therapy
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Beijing YouAn Hospital
First posted: 2014-07-29
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: HCC patients with tumors \>5 cm in diameter, regardless of involvement in the intrahepatic and extrahepatic portal branches participated in the study. Patients were randomized allocated in liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered to patients twice.


Eligibility criteria: Inclusion Criteria:

* 18～70 years of age (Male and Female).
* Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation
* Patients who had unresectable HCC \>5 cm and no metastasis in lungs and bones were eligible to participate in this study. Tumor involvement in the intrahepatic and extrahepatic portal branches was not considered to be an exclusion criterion.
* No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks.
* Provide written informed consent

Exclusion Criteria:

* Metastasis in lungs and bones
* Invasion in main vescular.
* Contraindications of liver transplantation
* Contraindications of operation of other organ system
* Hypersensitivity to adenovirus, GCV or similar drugs
* Accept clinical trials of other drugs
* Immunological deficit
* Active pregnancy
* Unable or unwilling to sign informed consents

Primary outcomes:
measure: Overall survival rate
timeFrame: up to 3-year
measure: Recurrence-free survival rate
timeFrame: up to 3-year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Huazhong University of Science and Technology
name: Ding Ma, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00149864: Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302
Official title: Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in Maintenance Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplant
Keywords: Renal Transplant, adults, immunosuppressant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of the study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF to enteric-coated mycophenolate sodium.


Eligibility criteria: Inclusion Criteria:

-First cadaveric, living unrelated or living related donor kidney transplant recipients who completed study CERL080A302

Exclusion Criteria:

* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To assess the incidence and severity of GI adverse events (AEs) and neutropenia in the first 3 months of treatment in maintenance renal transplant patients.
Secondary outcomes:
measure: Safety/efficacy based on adverse event (AE) reporting.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: