louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05175287: OSA (oRisk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association
Official title: Risk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep apnea
daytime sleepiness
accidents
bus drivers
Lead sponsor: Respiralab
Sponsor class: OTHER
Collaborators: name: Universidad de Especialidades Espíritu Santo
First posted: 2022-01-03
Enrollment: 340
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 340 male professional bus drivers whose mean age was 44.3 in the city of Guayaquil, Ecuador.

Brief summary: Our study aims to determine the frequency of individuals at high risk of obstructive sleep apnea, and excessive daytime sleepiness, as well as any potential association between these conditions and traffic accidents among a sample of Ecuadorian bus drivers.

Detailed description: We conducted a cross-sectional study from September 2019 to January 2020 among 340 male professional bus drivers in the city of Guayaquil, Ecuador. To be included in the study, participants were required to be male, have an unexpired professional driver's license, as well as being currently enrolled at any local transformational company. Individuals who did not met the inclusion criteria, or who declined voluntary participation were excluded from the study. We screened 340 male professional bus drivers whose mean age was 44.3. We analyzed demographic and clinical variables including age, educational level, associated comorbidities (hypertension and diabetes), years as a professional driver, and number of accidents and near-accidents while working. Accidents were defined as a collision involving the vehicle in which the participant was the driver and another vehicle or stationary obstruction. Near-accidents were defined as unplanned events involving the driver that did not result in injury but had the potential to do so. We used STOP questionnaire to assess four questions related to snoring, tiredness during daytime, observed apnea, and high blood pressure (STOP), and the Bang aspect for screening BMI ≥ 35, age ≥ 50, neck circumference \> 40 cm and male gender. Also, we used Epworth Sleepiness Scale (ESS) to assess excessive daytime sleepiness (EDS).

Eligibility criteria: Inclusion Criteria:

* Male
* Have an unexpired professional driver's license
* Being currently enrolled at any local transformational company

Exclusion Criteria:

* Not meeting inclusion criteria
* Declined voluntary participation

Primary outcomes:
measure: Obstructive sleep apnea
timeFrame: 4 months
Secondary outcomes:
measure: Excessive daytime sleepiness (EDS)
timeFrame: 4 months
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Respiralab Research Group
state: Guayas
Study officials:
References:
Clinical trial NCT02820987: PK/PD of Extended-infusion Meropenem, Piperacillin-tazobactam and Cefepime in the Early Phase of Septic Shock
Official title: Pharmacokinetics and Pharmacodynamic (PK/PD) of Extended-infusion Meropenem, Piperacillin-tazobactam and Cefepime in the Early Phase of Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Septic Shock
Keywords: Septic shock, Beta Lactams, Extended infusion, PK/PD
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates PK/PD of an extended-infusion protocol of meropenem, piperacillin-tazobactam and cefepime, in the early phase of septic shock.

Detailed description: Beta Lactams are the keystones of shock septic treatment. Early phase of septic shock is a period of disturbed pharmacokinetics, with augmented renal clearance and distribution volume of hydrophilic drugs as Beta Lactams. Consequently, early phase of septic shock is a period at risk of underdosing Beta Lactam, which could increase the risk of clinical failure an mortality.

Data are available concerning underdosing of MEROPENEM, PIPERACILLIN-TAZOBACTAM and CEFEPIME, when administered in bolus.

No data exist concerning the achievement of a target of 100% of the whole interval above 4 time the superior breakpoint of Pseudomonas Aeruginosa according to EUCAST (European Committee on Antimicrobial Susceptibility Testing), during the 48 first hours of treatment of septic shock, when Beta Lactam are administered in extended infusion.

Eligibility criteria: Inclusion Criteria:

* Septic shock
* Meropenem, piperacillin-tazobactam or cefepime started after enrollment

Exclusion Criteria:

* Pregnancy
* Central nervous system infection
* Burns

Primary outcomes:
measure: Proportion of patients achieving the PK/PD target
timeFrame: First 48 hours
Secondary outcomes:
measure: All cause mortality
timeFrame: 28th day
Other outcomes:
Locations:
city: Besançon
country: France
facility: Chu Besancon
Study officials:
References:
citation: Taccone FS, Laterre PF, Dugernier T, Spapen H, Delattre I, Wittebole X, De Backer D, Layeux B, Wallemacq P, Vincent JL, Jacobs F. Insufficient beta-lactam concentrations in the early phase of severe sepsis and septic shock. Crit Care. 2010;14(4):R126. doi: 10.1186/cc9091. Epub 2010 Jul 1.
citation: Winiszewski H, Despres C, Puyraveau M, Lagoutte-Renosi J, Montange D, Besch G, Floury SP, Chaignat C, Labro G, Vettoretti L, Clairet AL, Capellier G, Vivet B, Piton G. beta-lactam dosing at the early phase of sepsis: Performance of a pragmatic protocol for target concentration achievement in a prospective cohort study. J Crit Care. 2022 Feb;67:141-146. doi: 10.1016/j.jcrc.2021.10.023. Epub 2021 Nov 9.
Clinical trial NCT03989687: Clinical Retention of Glass Ionomer Sealants Placed With and Without Rubber Dam: a Comparative Analysis
Official title: Clinical Retention of Glass Ionomer Sealants Placed With and Without Rubber Dam: a Comparative Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries in Children
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 18
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: each patient is serving as their own control
Primary purpose: PREVENTION

Brief summary: A comparative analysis of glass ionomer sealant placed on permanent molars with and without a rubber dam to assess the retention over a 2 year period.

Detailed description: The purpose of the study is to compare the retention rates of glass ionomer sealants placed on first permanent molars over a period of 2 years. Pediatric patients (under \<10 years of age) will receive a glass ionomer sealant on all four permanent first molars. One side will be randomly selected with rubber dam isolation and the contralateral side will have no rubber dam isolation for the placement of the sealant. Over a 2 year period, every 6 months the sealants will be assessed for retention.

The glass ionomer sealant material will be Fuji Triage (GC America). The following dental materials that will be used are cotton rolls, non-latex rubber dam, topical benzocaine, dental mirror, glass ionomer dispensing gun, dental explorer, triturator for the glass ionomer, cotton gauze, suction tip, air-water syringe.

Eligibility criteria: Inclusion Criteria: healthy children who need sealants on 4 permanent molars that are not hypo plastic, are caries-free, and with no enamel defects.

-

Exclusion Criteria: hypoplastic molars, caries, teeth with existing restorations, and those with enamel defects,

-

Primary outcomes:
measure: retention rate of sealants
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: LSUHSC
name: Suzanne Fournier, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02900287: Cancer Survival in Reunion Island , 1998-2008 (SUCRE)
Official title: Survie Des Personnes Atteintes de Cancer à la Réunion, 1998-2008 (SUCRE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Keywords: Survival
Cancer
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 18000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population extracted from Reunion Island Cancer Registry

Brief summary: Cancer survival is important to determine prognostic of patients and evaluate care and prevention health strategies. Sucre is the first study to describe cancer survival in Reunion Island. Sucre aims at evaluating five year cancer prognostic in Reunion Island by cancer site and gender. Sucre is a retrospective cohort study of cancer diagnosed between 01/01/1998 and 31/12/2008.

Detailed description: Data are extracted from Reunion Island Cancer Registry.

Eligibility criteria: Inclusion Criteria:

* Patients domiciled in Reunion Island at diagnosis
* Patients with at least 15 years of age at diagnosis
* Patients with cancer diagnosis between 01/01/1998 and 31/12/2008

Exclusion Criteria:

* Cutaneous malignant cancer expected melanoma

Primary outcomes:
measure: 5 years related survival rate by cancer site and gender
timeFrame: 5 years
Secondary outcomes:
measure: 1, 3, 5 and 10 years related survival rate by cancer site and gender
timeFrame: 1, 3, 5 and 10 years
measure: 1, 3, 5 and 10 years standardised survival rate by cancer site and gender
timeFrame: 1, 3, 5 and 10 years
measure: 1, 3, 5 and 10 years related survival rate by age at diagnosis
timeFrame: 1, 3, 5 and 10 years
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de La Réunion
Study officials:
References:
Clinical trial NCT00395187: A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
Official title: A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hidradenitis Suppurativa
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: DUSA Pharmaceuticals, Inc.
First posted: 2006-11-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy of Photodynamic Therapy (PDT), which is the therapeutic use of photochemical reactions, in treating hidradenitis suppurativa (HS), a chronic inflammatory condition affecting areas of skin with sweat glands. We expect that PDT is effective in treating HS.

Detailed description: This study will investigate the efficacy of PDT using aminolevulinic acid (ALA) and either blue light or intense pulsed light on active lesions of HS. We will attempt to validate the success noted in a previously published case series using PDT with ALA and blue light (Gold, Bridges et al). We will evaluate effect of treatment by number of lesions, global disease severity, and patient self-assessment with the Dermatology Life Quality Index (DLQI).

Detailed informed consent will be obtained prior to treatment at study enrollment. The first four treatment visits will involve clinical evaluation, photography and application of the ALA to the affected area. After a 45 minute incubation period, the area will be washed and then treated with either blue light or intense pulsed light (IPL), depending on body area/investigator choice. One and three-month follow-up visits will involve evaluation of efficacy, but no active treatment.

Gold M, Bridges TM, et al. ALA-PDT and blue light therapy for hidradenitis suppurative. J Drugs Dermatol. 2004; 3 (1 Suppl):S32-5.

Eligibility criteria: Inclusion Criteria:

* multiple lesions consistent with HS in axillae/groin
* history of no or poor response to at least one treatment modality
* no active treatment in the 2 weeks prior to study initiation

Exclusion Criteria:

* Pregnancy/lactation
* photosensitizing drug use within 30 days of start of study
* active infection needing antibiotics
* history of porphyria or photosensitivity

Primary outcomes:
measure: Active and inactive lesion count
timeFrame: 0,1,2,3,4,8,16 weeks
Secondary outcomes:
measure: Regional disease severity will be assessed at each visit. Global Severity Score will be assigned by investigator. Assessed at all 6 visits, Patient self -assessment (DLQI) at visits 4-6,-Digital photographs-all 6 visits,Safety/adverse event monitoring.
timeFrame: 0,1,2,3,4,8,16 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Daniel Aires, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06242587: Impar VS Coccygeal Block in the Treatment of Coccidine
Official title: Comparison of Coccygeal Block and Impar Block for the Treatment of Coccydynia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coccyx Injury
Coccygeal Body Tumor
Keywords: Coccigodynia
Coccigeal pain treatment
Pericoccigeal nerve block
Impar ganglion block
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 32
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: The aim of this study was to evaluate the efficacy of coccygeal nerve blockade. Impar sympathetic ganglion blockade is a common treatment method used in coccygeal pain. However, experience with the coccygeal nerve is scarce in the literature. The investigator planned to follow up coccidynia patients who underwent impar sympathetic ganglion blockade and coccygeal nerve blockade for 3 months after the procedure. The investigator's aim is to compare the efficacy of coccygeal nerve blockade with impar blockade.

Detailed description: Patients with coccygeal pain will be evaluated. Patients with organic pathology such as malignancy and infection on imaging and investigations will be excluded. Seventy-four patients diagnosed with traumatic or idiopathic coccidynia will be included in the study. Patients will be randomised by computer programme. Half of them will undergo ultrasound-guided pericoccygeal nerve blockade and the other half will undergo fluoroscopy-guided impar sympathetic ganglion blockade. Pericoccygeal nerve block is performed with the patients lying in the prone position. The sacral horns are visualised using a linear probe. The coccygeal nerves are captured medial to the sacral cornuas and a combination of local anaesthetic and dexamethasone is injected. Impar sympathetic ganglion blockade It is performed in the operating theatre with the patient in the prone position. The sacrum and coccyx are visualised with a lateral view. A needle is inserted through the sacrococcygeal junction and a combination of local anaesthetic and dexamethasone is injected when an optimal image is obtained with contrast material injection. Patients will be evaluated before, 1 and 3 months after the procedure by filling out the Visual analogue scale and PARIS functional coxidynia questionnaire. The investigator who evaluates the patients and collects the data after the procedure will be blinded.

Eligibility criteria: Inclusion Criteria:

* Coccygeal pain

Exclusion Criteria:

* Malignite
* Infection
* Pregnancy

Primary outcomes:
measure: Visual analogue scale
timeFrame: Before treatment, week 4 and week 12
Secondary outcomes:
measure: PARIS coccidini scale
timeFrame: Before treatment, week 4 and week 12
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gevher Rabia Genç Perdecioğlu
state: Çankaya
Study officials:
References:
Clinical trial NCT02687087: A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy
Official title: Assessing the Safety and Effectiveness of Visco-ease for the Treatment of Radiotherapy Induced Xerostomia in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Keywords: Radiotherapy Induced Xerostomia (RIX)
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: Lamellar Biomedical Ltd
name: University of Glasgow
First posted: 2016-02-22
Enrollment: 44
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: The purpose of this study is to evaluate the clinical safety and effectiveness of Visco-ease dry mouth spray for the treatment of Radiotherapy Induced Xerostomia (RIX) in head and neck cancer patients.

A parallel group double blind study design has been selected. The primary outcome is change in GRIX scores from baseline (visit 1) to end of treatment (visit 7). The primary outcome will be compared between Visco-ease and the placebo treatment.


Eligibility criteria: Inclusion Criteria:

1. Subject has provided written informed consent
2. Male or female subjects ≥ 18 years of age
3. Subjects prescribed radiotherapy or chemoradiotherapy as primary treatment for head and neck tumours where one or more parotid glands will receive a significant dose of radiation as judged by the CI or PI during the radiotherapy planning process

Exclusion Criteria:

1. Subject is pregnant or breastfeeding
2. Subjects with known allergies to egg, soya, or lanolin (sheep's wool grease) based products
3. Subjects with a history of an autoimmune disease with pre-treatment xerostomia (e.g. Sjögren's syndrome) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure
4. Subjects who have participated in an investigational medicinal product study within 30 days prior to signing consent
5. Any clinically significant disease or condition that may interfere with the study treatment or outcome of the study (at the discretion of the CI or PI)
6. Subjects who are unable to independently complete the questionnaire or diary
7. Subjects who are judged inappropriate for inclusion in the study by the CI or PI
8. Subjects with head and neck cancer who have had surgery to the primary site. Neck dissection alone is not an exclusion

Primary outcomes:
measure: Change in GRIX Score
timeFrame: From baseline (Visit 1) to end of treatment (Visit 7, after 6 weeks of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Lanarkshire
Study officials:
affiliation: Beatson West of Scotland Cancer Centre
name: Claire Paterson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06613087: Effect of Foot Bath on the Severity of Pain, Fatigue and Insomnia in Patients With Acute Renal Failure
Official title: Effect of Foot Bath on the Severity of Pain, Fatigue and Insomnia in Patients With Acute Renal Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Failure
Pain
Keywords: foot bath
insomnia
fatigue
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 50
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: SUPPORTIVE_CARE

Brief summary: One of the non-pharmacological methods that is easily applied, tolerated by the patient, and has no significant side effects is the foot bath. The aim of this study is to determine the effect of a foot bath applied to patients with acute renal failure on the severity of pain, fatigue, and insomnia.

Detailed description: Introduction: One of the non-pharmacological methods that is easily applied, tolerated by the patient, and has no significant side effects is the foot bath.

Objective: The aim of this study is to determine the effect of a foot bath applied to patients with acute renal failure on the severity of pain, fatigue, and insomnia.

Method: The sample of this study will consist of 54 individuals who meet the inclusion criteria among patients with acute renal failure hospitalized in the internal medicine department of a training and research hospital in Amasya. The research data will be collected using a personal information form, numerical pain scale, fatigue severity scale, and insomnia severity index.

Conclusion: In diseases such as acute renal failure that develop suddenly and require hospitalization, it is important to use and evaluate the effectiveness of simple, applicable non-pharmacological methods in order to quickly control the symptoms of patients and ensure their comfort. The study results will contribute to the literature in this field.

Eligibility criteria: Inclusion Criteria:

* Those over the age of 18
* Those hospitalized in the internal medicine clinic with a diagnosis of acute renal failure
* Those who speak and understand Turkish
* Those who consent to participate in the study

Exclusion Criteria:

* Those with cognitive dysfunction
* Those diagnosed with chronic renal failure
* Those with wounds on their feet
* Those whose vital signs are not within normal limits (fever, high blood pressure, bradycardia, tachycardia, etc.)
* Those receiving hemodialysis treatment for acute renal failure
* Those taking medication for insomnia
* Those who did not consent to participate in the study

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: 5 day
measure: Fatigue Severity Scale
timeFrame: 5 day
measure: Insomnia Severity Index
timeFrame: 5 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: