louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02485860: Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst
Official title: Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pilonidal Cysts
Keywords: pilonidal cysts
Cavity wound
long healing
honey
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 890
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: The management of pilonidal cysts is a skin excision and under deep skin. Scarring requires regular dressings (daily for 15 days and then every 48 hours) until complete healing. This healing is obtained on average in 68 days. Some patients have difficulties in healing with a final healing achieved on average in 95 days. Some teams use honey to promote wound cavitary wounds (wound infection, pressure ulcers, varicose wound). The acceleration of wound healing is due to antibacterial properties and hyperosmolarity to reduce secretions. ) The use of honey in pilonidal cysts is not evaluated and may accelerate healing.


Eligibility criteria: Inclusion Criteria:

* Cavity Wound to 6 weeks of a pilonidal cyst excision
* Bloodless wound
* Pilonidal cyst not recurred
* Age : 18 years and older
* Signature of informed consent
* In the capacity to understand the study

Exclusion Criteria:

* Bleeding wound
* Refused to participate in Protocol
* Patient immunocompromised
* Recurrent pilonidal cyst
* Patients on long-term corticosteroid
* Patient deprived of liberty, under guardianship
* Patient unable to understand the study
* Allergy or hypersensitivity to honey
* Allergy Or hypersensitivity to hyaluronic acid
* Allergy or hypersensitivity to guar gum
* Allergy or hypersensitivity to pectin
* Known allergy to propolis (potentially present in honey)
* Sensitivity to zinc oxide
* Sensitivity known dressings used in this trial or any component
* Diabetes Non-insulin or insulin

Primary outcomes:
measure: Healing Time
timeFrame: from randomization to 180 days maximum
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Departemental Vendée
Study officials:
affiliation: Centre Hospitalier Departemental Vendee
name: Emeric ABET, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04005560: Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit for a Severe Bacterial Infection
Official title: Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit for a Severe Bacterial Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Sequela
Keywords: severe bacterial infection
quality of life
long term sequela
pediatric intensive care unit
children
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 47
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to assess patient's quality of life 5 to 10 years after a severe bacterial infection with hospitalization in a intensive unit care. The population is derived from the DIABACT III study. The investigators will include every patient still alive. To evaluate our question, patients and their parents will answer quality of life questionnaires. The investigators will also have telephone interviews with the parents to know somatic and psychological effects on their child.

The investigators will see if quality of life and sequelae differ depending on various studied factors.

Detailed description: The aim of this study is to assess patient's quality of life 5 to 10 years after hospitalization in intensive car unit for a severe bacterial infection. The population is derived from DIABACT III study, and includes all patients still alive.

To evaluate their quality of life, patients and parents will answer specific questionnaries. The Pediatric Quality of Life inventory (PedSQL) has various versions for children depending on their age, adults and parents. The investigators will get physical, emotional, social and academic scores.

To assess somatic and psychological effect after the severe bacterial infection, the investigators will have telephone interviews with the parents, with many questions about organs disorders, specialized medical follow-up, medication, need physical or material assistance, financial and psychological family impact... The investigators will examine data from DIABACT III study to assess determinants of the quality of life for these patients.

Eligibility criteria: Inclusion Criteria:

* Every patients from DIABACT III study still alive at the beginning of this study

Exclusion Criteria:

* Patients who did not respond to the questionnaire
* Inability to contact the patient and family
* No fixed postal address

Primary outcomes:
measure: This quality of life will be evaluated by a questionnaire, the Pediatric Quality of Life inventory.
timeFrame: 6 months
Secondary outcomes:
measure: Identify quality of life determinants.
timeFrame: 6 months
measure: Assess long-term sequelae: evaluate somatic and psychological effects. We will have telephone interviews with the parents.
timeFrame: 6 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
References:
Clinical trial NCT00392860: Development of an Ergonomic Wheelchair Pushrim
Official title: Development of an Ergonomic Manual Wheelchair Pushrim- Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: Wheelchair
Handrims
Rehabilitation
Upper extremity
Lead sponsor: VA Pittsburgh Healthcare System
Sponsor class: FED
Collaborators: name: University of Pittsburgh
First posted: 2006-10-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the effectiveness of newly designed ergonomic manual wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard handrim. It is our hope that the new design of the handrims will help reduce upper extremity pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim was designed to directly address the shortcomings of standard handrims and to improve the standard-round tube handrims which were designed over 50 years ago. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.

Detailed description: This research will have three parts.

The first part will include completing propulsion and braking tasks with the subject's original handrims. After the initial testing, new handrims (NaturalFit, PalmRim, and a new standard handrim) will be installed on the subject's wheelchair and subjects will again be asked to complete another set of propulsion and braking tasks. Subjects will also be asked to complete a questionnaire to assess wrist and shoulder pain and undergo an examination of the condition of the palm of their hand.

For the second part of the study, subjects will be asked to participate in a 4-month trial use period of the new handrims on their wheelchair.

In the third part of the study, subjects will complete the final set of propulsion and braking tasks and complete a follow-up questionnaire.

Eligibility criteria: Natural-Fit

Inclusion Criteria:

* Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)
* Use a standard handrim
* Between the ages of 18 and 55
* Has normal hand function

Exclusion Criteria:

* Pressure Sores

PalmRim

Inclusion Criteria:

* Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)
* Use a vinyl-coated handrim
* Between ages 18 and 55
* Has impaired hand function

Exclusion Criteria:

* Pressure sores

Primary outcomes:
measure: Change in Functional Status Score
timeFrame: Baseline, 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Human Engineering Research Laboratories
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh and VA Pittsburgh Healthcare System
name: Michael L Boninger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00435760: Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Single Dose, Double-blind, Double-dummy, 3 Period Cross-over, Placebo Controlled Clinical Trial to Assess the Reate of Onset of Action of Inhaled Aclidinium Bromide 200µg Compared to Placebo and Tiotropium 18µg in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-02-15
Enrollment: 115
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.

Detailed description: This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.

Eligibility criteria: Inclusion Criteria:

* Males and females aged ≥ 40 years
* Current or ex-smokers of ≥ 10 pack-year
* Clinical diagnosis of severe stable COPD

Exclusion Criteria:

* History or current diagnosis of asthma, allergic rhinitis, or atopy
* Respiratory tract infection or acute COPD exacerbation in the last 6 weeks
* Hospitalised for an acute COPD exacerbation in the last 3 months
* Evidence of contraindicated use of anticholinergic drugs

Primary outcomes:
measure: FEV1 Percentage Increase
timeFrame: 30 minutes
Secondary outcomes:
measure: Normalised Area FEV1 AUC 0-3h
timeFrame: 0-3 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Respiratory Clinical Trials Ltd
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04902560: Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study
Official title: Overall Patient Care in a Montpelier Sexual Health Center (CeGIDD). Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gonorrhea
Keywords: Neisseria gonorrhoea
Ceftriaxone
Treatment
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 120
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: Patient Having at least one exam positive for Gonorrhoea (PCR or Culture), realised in CeGIDD de Montpellier

Brief summary: Sexual health centers (CeGIDD, in France) manage the majority of STI in France, especially gonorrhea.

Patients wanting STI screening can consult either they are symptomatic or not.

If they are symptomatic, they can be treated immediately. If they are not symptomatic, they must come back seven days after in order to get their results and to be treated if necessary.

Before any treatment for gonorrhea, subjects should be sampled for bacterial culture in order to perform AMR surveillance.

After every treatment for gonorrhea, subjects should realized a test of cure (TOC) according to current recommandation.

Response rate to ceftriaxone 1g IM for treating gonorrhea has never been evaluated in France while being used widely over the past months.

Compliance to current recommandation at CeGIDD Montpellier has never been evaluated.

This study will assess the response rate to ceftriaxone 1g IM as gonorrhea treatment by realizing a test of cure 14 days after each treatment.


Eligibility criteria: Inclusion criteria:

* Aged more than 18 years old
* Non-opposition form given to the subject
* Having at least one exam positive for Gonorrhoea (PCR or Culture), realised in CeGIDD de Montpellier

Exclusion criteria:

- patient's refusal to participate

Primary outcomes:
measure: Response rate to Ceftriaxone 1g IM in Gonorrhoea.
timeFrame: day 1
Secondary outcomes:
measure: Adverse drug reaction rates
timeFrame: day 1
measure: Concordance rate with positive PCR
timeFrame: day 1
measure: Resistance rate to ceftriaxone and AMR description.
timeFrame: day 1
measure: Rate of untreated patient despite having a positive test for gonorrhea (lost to follow-up)
timeFrame: day 1
measure: Rate of realized TOC
timeFrame: day 1
measure: Rate of time before realizing the TOC.
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Du Thanh Aurelie
role: STUDY_DIRECTOR
References:
Clinical trial NCT00668460: Dermatological Evaluation of Topic Compatibility-Dermacyd Delicata Pocket BR
Official title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Delicata Pocket BR.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Pocket BR.


Eligibility criteria: Inclusion Criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs
* Personnel history of atopy
* History of sensitivity or irritation for topic products
* Active cutaneous disease
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The absence of primary and accumulated dermal irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05960760: Attitudes Towards Back and Back Pain in German-speaking Switzerland
Official title: Assessing the Cross-cultural Validity and Reliability of the German Version of the Back Pain Attitudes Questionnaire (Back-PAQ_G) Within the German-speaking Swiss Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for this study includes individuals with and without back pain and primary care healthcare professionals. This includes physicians, physiotherapists, and nurses.

Brief summary: This research aims to assess the cross-cultural validity and reliability of the German version of the Back-PAQ (Back-PAQ_G) within the German-speaking Swiss population.

The target population for this study includes individuals with and without back pain and primary care healthcare professionals. This includes physicians, physiotherapists, and nurses. The participants will be asked to fill out the Back-PAQ_G and similiar questionnaires online.


Eligibility criteria: Inclusion Criteria:

* Living within the German-speaking part of Switzerland

Exclusion Criteria:

* Insufficient German language skills

Primary outcomes:
measure: Back Pain and Attitudes Questionnaire
timeFrame: baseline
Secondary outcomes:
measure: Tampa Scale of Kinesiophobia
timeFrame: baseline
measure: Fear Avoidance Belief Questionnaire
timeFrame: baseline
Other outcomes:
Locations:
city: Muttenz
country: Switzerland
facility: 4 Balance Zentrum für Physiotherapie und medizinisches Training
state: Baselland
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur (KSW)
Study officials:
affiliation: ZHAW, Department Gesundheit, Institut für Physiotherapie
name: Fabian Pfeiffer, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Darlow B, Perry M, Mathieson F, Stanley J, Melloh M, Marsh R, Baxter GD, Dowell A. The development and exploratory analysis of the Back Pain Attitudes Questionnaire (Back-PAQ). BMJ Open. 2014 May 23;4(5):e005251. doi: 10.1136/bmjopen-2014-005251.
Clinical trial NCT02111460: Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma
Official title: Multicentre Randomization Clinic Trial of Systemic Chemotherapy Combined With Loco-regional Radiotherapy vs. Chemotherapy Alone for Initially Untreated Distant Metastatic Nasopharyngeal Carcinoma With Chemosensitivity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Initially
Untreated
Distant metastatic
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Guangdong Provincial People's Hospital
First posted: 2014-04-11
Enrollment: 126
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: This is a randomized parallel control trial to evaluate whether radical loco-regional Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

* The patients with initial untreated metastatic nasopharyngeal carcinoma
* Histologic diagnosis of nasopharyngeal carcinoma
* T1-4N0-3M1,IVC(according to the 7th AJCC edition)
* Aged between 18 and 65 years
* KPS≥70
* The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu
* Voluntary to participate and sign informed consent document

Exclusion Criteria:

* The patients suffered from serious neurologic disease
* Clinically significant cardiac, heart function less than or equal to 3 level
* Clinically significant respiratory disease,lung function less than or equal to 3 level
* Blood routine examination: WBC\<3×109/L, Hemoglobin\<90g/L, platelet count\<75×109/L
* Abnormal liver function: total bilirubin or ALT or AST\>2×ULN
* Abnormal renal function:serum creatinine\>1.5×ULN
* Pregnant or lactating women
* The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Progress-free survival
timeFrame: 2 years
measure: Complete Response (CR)
timeFrame: after the completion of the chemoradiotherapy treatment (up to 9 weeks)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming y Chen, MD,Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: You R, Liu YP, Huang PY, Zou X, Sun R, He YX, Wu YS, Shen GP, Zhang HD, Duan CY, Tan SH, Cao JY, Li JB, Xie YL, Zhang YN, Wang ZQ, Yang Q, Lin M, Jiang R, Zhang MX, Hua YJ, Tang LQ, Zhuang AH, Chen QY, Guo L, Mo HY, Chen Y, Mai HQ, Ling L, Liu Q, Chua MLK, Chen MY. Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1345-1352. doi: 10.1001/jamaoncol.2020.1808.
Clinical trial NCT04499560: The Effects of a Nutrition Supplement on Health Related Quality of Life
Official title: The Effects of a Nutrition Supplement on Health Related Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Stress
Health, Subjective
Inflammation
Cognitive Symptom
Keywords: immune health
prevention
phytonutrients
superfoods
antioxidant
essential oils
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
Collaborators: name: Young Living Essential Oils
First posted: 2020-08-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.

Detailed description: After being informed about the study, participants will provide informed consent and be randomized to one of two groups: intervention or control. Those in the intervention group will consume two ounces of a superfoods drink each morning for 60 days. Outcomes will be assessed at baseline, on day 30 and on day 60.

Eligibility criteria: Inclusion Criteria:

* otherwise healthy
* adults living in the US
* is practicing adequate contraception or is abstaining from all activities which could result in pregnancy
* understands and agrees to comply with study procedures
* provides informed consent

Exclusion Criteria:

* smoker
* pregnant or may become pregnant
* currently breastfeeding
* currently taking antioxidant supplements
* underlying chronic health conditions
* COVID-19 diagnosis
* demonstrated inability to comply with study procedures
* history of allergy to citrus or berry fruits
* has participated in an interventional clinical study within 31 days prior to enrollment

Primary outcomes:
measure: Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60
timeFrame: Baseline and day 60
measure: Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60
timeFrame: Baseline and day 60
measure: Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60
timeFrame: Baseline and day 60
measure: Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60.
timeFrame: Day 60
measure: Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60
timeFrame: Baseline and Day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin School of Integrative Health Sciences
state: Tennessee
Study officials:
affiliation: Nutraceuticals Research Institute
name: Jessie Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References: