louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00446056: Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)
Official title: Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-03-12
Enrollment: 188
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 weeks in patients with pediatric bronchial asthma aged 6 to \< 15.

The effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study.


Eligibility criteria: Inclusion Criteria:

* Intermittent asthma, mild persistent asthma, moderate persistent asthma, or severe persistent asthma patients with 2 or more mild or moderate attacks at baseline

Exclusion Criteria:

* Patient using anti-asthma treatment or therapy including corticosteroids or oral anti-allergic drugs
* Patient with complications that will impair the judgment of efficacy of this drug
* Patient with convulsive disorders such as epilepsy or such a history
* Patient with liver disease, renal impairment, heart disease or such other complication

Primary outcomes:
measure: Improvement of morning peak expiratory flow over first 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Sankei N, Kenshi F, Susumu F, Shigemi Y. Cysteinyl leukotriene receptor 1 antagonist; monterukast on childhood bronchial asthma in multicenter comparative double-blind study (Phase IV) with ketotifen fumarate. J Clin Therapeut Med. 2005;21(6):605-636
Clinical trial NCT03841656: Influence of Gum Disease Treatment on Long-term Dental Implant Success
Official title: Influence of Periodontal Care Response on Implant Treatment Outcomes at Long-term
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015.

Brief summary: The aim of this study is to evaluate the influence of periodontal care response on long term dental implant success. Investigator's hypothesis is that patients who do not well respond to periodontal care have more chance to develop peri-implant complications at long-term. The second purpose of this study is to evaluate the influence of other local, systemic, behavioral, and implant's related risk factors


Eligibility criteria: Inclusion Criteria:

Patient attending supporting periodontal therapy with at least one implant placed for more than 3 years

* Patient with more than 12 teeth at baseline
* Patient with demographic, periodontal, implant data recording
* patient aged \>30 years at Baseline

Exclusion criteria:

* Patient needed antibiotic prophylaxis
* Uncontrolled diabetes
* Systemic inflammatory or autoimmune diseases

Primary outcomes:
measure: Presence of peri-implantitis as measured by probing depth
timeFrame: At least 3 years after dental implant placement
measure: Presence of peri-implantitis as measured by erythema
timeFrame: At least 3 years after dental implant placement
measure: Presence of peri-implantitis as measured by radiographic bone loss
timeFrame: At least 3 years after dental implant placement
Secondary outcomes:
measure: Implant survival
timeFrame: At least 3 years after dental implant placement
Other outcomes:
Locations:
Study officials:
References:
citation: Papalou I, Vagia P, Cakir A, Tenenbaum H, Huck O, Davideau JL. Influence of Periodontitis, Implant, and Prosthesis Characteristics on the Peri-Implant Status: A Cross-Sectional Study. Int J Dent. 2022 Feb 7;2022:9984871. doi: 10.1155/2022/9984871. eCollection 2022.
Clinical trial NCT00602056: Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule
Official title: A Randomized Controlled Trial of Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule in a Low Literacy Population in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Immunization Completion
Childhood Immunization Dropout
Immunization Card
Center Based Education
Keywords: Immunization dropout
Immunization card
Center based education
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 1506
Sex: ALL
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of the study was to assess the effect of 1) redesigned immunization card, 2) center-based education to mothers, and 3) redesigned card with center-based education to mothers, provided at DPT1, on DPT3 completion in a randomized controlled trial at rural Expanded Programme on Immunization (EPI) centers in Karachi, Pakistan.


Eligibility criteria: Inclusion Criteria:

* All children visiting the selected EPI centers for DPT1 immunization

Exclusion Criteria:

* Not residing in the same area for last six months.

Primary outcomes:
measure: The study outcome in each study group was the immunization status categorized into "DPT3 completed" and "DPT3 not completed".
timeFrame: 90 day follow-up after enrollment at DPT1 visit
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: EPI immunization centers
state: Sindh
Study officials:
affiliation: University of Alabama at Birmingham
name: Hussain R Usman, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06585956: Prevent Post-discharge Hospital Admissions Using Mobile Phone App
Official title: The Role of Physician-Patient Communication Through Mobile Phone Application in Preventing Emergency Room Admissions After Circumcision: a Randomized Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Anxiety
Patient Readmission
Circumcission
Telemedicine
Lead sponsor: Cumhuriyet University Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 184
Sex: MALE
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases of circumcision

Brief summary: The investigators aimed to assess the impact of a mobile phone application facilitating real-time visual and verbal communication on reducing emergency room admissions following circumcision.

Detailed description: Today, communication devices make our lives easier and provide convenience in the healthcare sector. Some studies have mentioned that a definitive diagnosis can be made with digital photographs and video images in children with normal findings at the time of examination, and further diagnostic tests become unnecessary . Readmission to the hospital after surgery, especially in children, is a situation that increases the level of anxiety. The use of smart device applications to evaluate both the operation site and functional results after many surgical procedures has reduced the number of re-applications and anxiety levels of patients . Through communication, the patient can articulate their needs to the physician, either verbally or visually, and with the assistance of the physician, navigate through this process much more smoothly. In our randomized prospective study, the investigators aimed to assess the role of a mobile phone application facilitating real-time visual and verbal communication, as well as instant information exchange, in reducing emergency room and urology policlinic admissions due to potential complications after circumcision.

Eligibility criteria: Inclusion Criteria:

* Circumcision

Exclusion Criteria:

* hypospadias
* cryptoorchidism
* bleeding diathesis

Primary outcomes:
measure: The Role of Physician-Patient Communication through Mobile Phone Application in Preventing Emergency Room Admissions after Circumcision: A Randomized Prospective Study
timeFrame: To estimate the change in the readmission rate during the participants; recovery period (2 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Cumhuriyet Univercity
Study officials:
References:
Clinical trial NCT04447456: Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy
Official title: Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glottic Carcinoma
Keywords: Glottic Squamous Cell Carcinoma
Surgery
Radiotherapy
Voice
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients treated for glottic squamous cell carcinoma at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017.

Brief summary: Patients with early-stage squamous cell carcinomas of the vocal cord can be treated in an equivalent way in terms of carcinology by surgery or radiotherapy. The study will be to analyse the vocal outcome at 5 years of these two types of management in order to define whether one is superior to the other on this criterion of voice quality after treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with glottic squamous cell carcinoma T1N0M0 who may benefit from treatment with exclusive radiotherapy or exclusive surgery.
* patients treated for these cancers at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017.
* Tis, T1a and T1b glottic squamous cell carcinomas according to the TNM 7th edition classification in long-term survivors.

Exclusion Criteria:

-

Primary outcomes:
measure: Voice Handicap Index
timeFrame: At 5 years
Secondary outcomes:
measure: Maximum Phonation Time
timeFrame: At 5 years
measure: Grade, Roughness, Breathiness, Asthenia, Strain, Instability SCORE (GRBASI Score)
timeFrame: At 5 years
measure: Acoustic Analysis by Vocalab software
timeFrame: At 5 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Hôpital Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: François Mouawad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00824356: Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo
Official title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis
Proof-of-Concept
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic


Eligibility criteria: Inclusion Criteria:

* Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
* Male
* Aged 18 - 65
* Weight 50kg+, BMI 19-32 kg/m2
* Exhibit response to Challenge Chamber and skin prick test.
* Non-smoker
* Capable of giving informed consent

Exclusion Criteria:

* No nasal structural abnornmality/polyposis, surgery, infection.
* any respiratory disease, other than mild asthma or seasonal allergic rhinitis
* participated in another clinical study within 30 days.
* Subject has donated a unit of blood within 1 month
* Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
* History of sensitivty to drug
* History of alcohol/drug abuse within 12 months.
* Positive Hepatitis B antibody test
* Positive HIV antibody test
* Risk of non-compliance with study protocol
* Perenial allergic rhinitis
* Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
* Past or present disease that may affect outcome, as judge by investigator Specific Immunotherapy within 2 years

Primary outcomes:
measure: Change from baseline in total nasal symptom score 0-4 hours post dose
timeFrame: 0-4 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02310256: A Clinical Trial on the Effects of Home-based Five Plus Exercise Training
Official title: A Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Keywords: Mitochondria, muscle
Exercise
Blood Flow Velocity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking. The study will elucidate if such a potential effect is dependent on changes in mitochondrial respiratory capacity, blood flow or both.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with intermittent claudication secondary to vascular insufficiency
* An ankle-brachial index between 0.4 and 0.9.

Exclusion Criteria:

* Diagnosed with critical limb ischemia
* Ankle-brachial index (ABI) \> 0.90 or \< 0.4
* Limited exercise tolerance
* Warfarin or heparin usage
* Underwent a vascular intervention in the last 6 months
* Active cancer, renal- or liver disease

Primary outcomes:
measure: absolute walking distance (meters) as measured by 6 minute walking test
timeFrame: 8 weeks
measure: mitochondrial function measured by respirometry
timeFrame: 8 weeks
Secondary outcomes:
measure: Arterial bloodflow measured by plethysmography
timeFrame: 8 weeks
measure: Quality of life assessed by SF 36 and CLAU-S questionnaires
timeFrame: 8 weeks
measure: Peak oxygen uptake measured by cardio-pulmonal exercise testing
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department for circulation and medical imaging, NTNU
state: Postboks 8905
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øivind Rognmo, phd
role: STUDY_DIRECTOR
References:
citation: Van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson E. Calf raise exercise increases walking performance in patients with intermittent claudication. J Vasc Surg. 2017 May;65(5):1473-1482. doi: 10.1016/j.jvs.2016.12.106. Epub 2017 Mar 9.
citation: van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson EJR. Exercise in claudicants increase or decrease walking ability and the response relates to mitochondrial function. J Transl Med. 2017 Jun 7;15(1):130. doi: 10.1186/s12967-017-1232-6.
Clinical trial NCT06663956: A Randomized Controlled Trial of a Web-based Platform for Cancer Pain Management
Official title: A Randomized Controlled, Open Clinical Trial of a Web-based Platform for Multifactorial Intervention in Cancer Pain Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cancer Pain
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Malignant tumors are one of the major public health problems in China, and cancer pain is a common symptom in tumor patients, affecting the quality of life. In rural areas, cancer pain management is challenging due to insufficient medical resources and limitations in understanding cancer pain. Investigators plan to develop a convenient patient self-reporting applet to help participants report their symptoms to primary care physicians promptly and monitor pain levels and medication in real-time. This project aims to improve the efficiency of cancer pain management, integrate cancer pain into chronic disease management, improve the quality of healthcare services for rural participants, and promote the construction of a healthy China.


Eligibility criteria: Inclusion Criteria:

* Patients with tumors that are confirmed by pathological findings.
* Presence of tumor-related pain that is moderate or higher and requires intervention with morphine-based pain medication (++).
* Have a life expectancy of more than 6 months.
* Understand and sign a consent to participate in the study, or if the patient is unable to understand the study, his/her direct caregiver must have a good understanding of the study.

Exclusion Criteria:

* Presence of other chronic non-cancer pain/have an unresolved pain-related condition.
* Moderately severe cognitive impairment/cognitive impairment.
* Have schizophrenia or other psychiatric illness.
* Neither the patient nor his/her direct caregiver can understand how to use the Cancer Pain Management applet.
* Being pregnant.

Primary outcomes:
measure: Patient's average pain level (derived from the Brief Pain Scale)
timeFrame: From patient enrollment to 3 months, during which time the applet was used once a week
Secondary outcomes:
measure: Mood and physical state of the patient (derived from the EQ-5D scale)
timeFrame: From patient enrollment to 3 months, during which time the applet was used twice a week
measure: Burden situation of family members (derived from the Family Support Scale)
timeFrame: From patient enrollment to 3 months, during which time the applet was used twice a week
measure: Patient quality of life (derived from the QLQ-C30 core quality of life questionnaire)
timeFrame: From patient enrollment to 3 months, during which time the applet was used twice a week
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan Universit
state: Sichuan
Study officials:
References:
Clinical trial NCT01083056: Observational Study - ILM Peeling
Official title: Observational Study On Retinal Structure And Function Before And After Epimacular Membrane Peeling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epimacular Gliosis
Macular Hole
Keywords: retina
gliosis
macula
membrane
ILM
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 10
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: Inpatients at the University Eye Hospital Tuebingen

Brief summary: This observational study investigates the effects of epimacular membrane peeling on the structure and function of the retina.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Epimacular Gliosis
* Must be scheduled for ILM-peeling independently of study
* Must be older then 18 years of age

Exclusion Criteria:

* Visual acuity \> 0,4 logMAR (\< 20/50 EDTRS)
* Other ophthalmological disorder affecting visual acuity and/or visual field and/or retinal structure

Primary outcomes:
measure: BCVA
timeFrame: 6 months after ILM peeling
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Centre for Ophthalmology, University Hospital Tuebingen
state: BW
Study officials:
affiliation: Centre for Ophthalmology, University Hospital Tuebingen
name: Florian Gekeler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06762756: Impact of Positive Mental Vs. Physical Health Messaging on Motivation to Stop Smoking
Official title: What is the Effect of Presenting Evidence of the Mental Vs Physical Health Benefits of Quitting Smoking on Motivation to Stop Smoking? an Online Randomised Controlled Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Tobacco
Keywords: Smoking
Smoking cessation
Public health
Mental health
Tobacco warning labels
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 631
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention was tobacco warning labels with three conditions: i) positive mental health labels; ii) positive physical health labels; iii) blank labels. Participants were randomly allocated to one label condition using Qualtrics embedded randomisation function, stratified by mental health status, and viewed four labels for at least 10 seconds each.
Primary purpose: OTHER

Brief summary: This study tested whether positive messages on tobacco packaging about the mental health benefits of quitting smoking could help motivate people to stop smoking. It compared three types of labels: ones focusing on mental health benefits, ones focusing on physical health benefits, and blank labels.

The experiment involved 631 people who smoke who were randomly shown one of these label types on an online survey platform. Participants' motivation to quit smoking was measured before and after viewing the labels.


Eligibility criteria: Inclusion Criteria:

1. Self-reported weekly tobacco smokers
2. Aged at least 18 years
3. Could read English

Exclusion Criteria:

Did not smoke tobacco at least weekly

Primary outcomes:
measure: Motivation to stop smoking
timeFrame: At baseline and follow up immediately after viewing the labels
Secondary outcomes:
measure: Intention to Quit
timeFrame: Measured at baseline and follow up immediately after viewing the labels
measure: Quitting Self-Efficacy
timeFrame: Measured at baseline and follow up immediately after viewing the labels
measure: Smoking Beliefs
timeFrame: Measured at baseline and follow up immediately after viewing the labels
measure: Attention
timeFrame: Measured at follow up immediately after viewing the labels
measure: Affective Reactions
timeFrame: Measured at follow up immediately after viewing the labels
measure: Believability
timeFrame: Measured at follow up immediately after viewing the labels
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
Study officials:
affiliation: University of Bath
name: Gemma Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References: