louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06495346: Identification and Characterisation of Sleep Disorders in a Population of Patients With Non-small Cell Lung Cancer
Official title: Identification and Characterisation of Sleep Disorders in a Population of Patients With Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cell Lung Cancer
Sleep Disorders
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of non-small cell lung cancer followed and treated by the Oncopneumology Department of the Nouvel Hôpital Civil in Strasbourg

Brief summary: This exploratory study will identify and characterise disorders frequently reported by patients as contributing to or altering their quality of life. This will enable a decision tree to be drawn up for diagnosis, referral and treatment of the sleep disorders collected, tailored to patients in this population.

This decision tree should help to improve the management of patients with a cancer diagnosis presenting with sleep disorders.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 and over.
* Being monitored and treated for non-small cell lung cancer.
* With or without ongoing cancer-specific treatment. With no neurocognitive impairment (MoCA test score ≥26/30).
* With a clinically assessed life expectancy of more than 3 months (Royal Marsden Hospital 0-1) and general health (ECOG \<2).
* Able to understand the study documents written in French
* Able to complete the study questionnaires written in French.
* Contactable by telephone throughout the study
* Affiliated to a social security scheme or entitled beneficiary
* Not opposed to taking part in the study

Exclusion Criteria:

* Patient refusing to take part in the study
* With a mental illness of the psychosis type monitored and treated prior to the study
* Patient under guardianship or curatorship
* Patient under court protection

Primary outcomes:
measure: Score sleep quality criteria (Pittsburgh Sleep Quality Index)
timeFrame: Every 14 days for 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: HUS
state: Grand Est
Study officials:
References:
Clinical trial NCT00559546: Montelukast as a Controller of Atopic Syndrome
Official title: Montelukast as a Controller of Atopic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Allergic Conjunctivitis
Atopic Eczema
Asthma
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-11-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.


Eligibility criteria: Inclusion Criteria:

* Wheal diameter at least 4 mm in skin-prick test for both birch and timothy
* Allergic symptoms in both upper airways (allergic rhinitis) and lower airways (asthma-like symptoms or diagnosed asthma) and at least one of the following:

  * Allergic conjunctivitis
  * Atopic eczema
  * Oral symptoms from vegetables or fruits by cross reactivity to birch
  * Urticaria in allergen exposure

Exclusion Criteria:

* Need for regular treatment with glucocorticoids
* Current smoking
* Other major disease or need for regular drug treatment
* Pregnancy

Primary outcomes:
measure: Allergic symptoms
timeFrame: 3 weeks
Secondary outcomes:
measure: Need for antihistamines or inhaled beta-2-agonists to relieve symptoms
timeFrame: 3 weeks
measure: Exhaled nitric oxide concentration
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Skin and Allergy Hospital, Helsinki University Hospital
Study officials:
affiliation: Skin and Allergy Hospital, Helsinki University Hospital
name: Tari Haahtela, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lehtimaki L, Petays T, Haahtela T. Montelukast is not effective in controlling allergic symptoms outside the airways: a randomised double-blind placebo-controlled crossover study. Int Arch Allergy Immunol. 2009;149(2):150-3. doi: 10.1159/000189198. Epub 2009 Jan 6.
Clinical trial NCT00161746: Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years
Official title: Multicentre Randomized Double-Blind Phase II/III Study on the Safety and Immunogenicity of Three Vaccinations With TICOVAC in Two Dosages in Healthy Children Aged Between Six Months and Three Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Encephalitis, Tick-borne
Keywords: Tick-Borne Encephalitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.


Eligibility criteria: Inclusion Criteria:

* Male and female children aged between 6 and 47 months
* No history of any previous TBE vaccination
* Clinically healthy
* Informed consent provided by the parents

Exclusion Criteria:

* History of allergic reactions, in particular allergic reactions to one of the components of the vaccine
* Suffering from a disease that cannot be effectively treated or stabilised
* Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions
* Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system
* HIV-positivity (no special HIV test required for the purpose of the study)
* Suffering from a febrile disease
* History of vaccination against yellow fever and/or Japanese encephalitis
* Participation in another clinical trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kapfenberg
country: Austria
facility: Wiener Strasse 50/2
city: Leoben
country: Austria
facility: Erzherzog Johann Strasse 9
city: Liezen
country: Austria
facility: Fronleichnamsweg 10
city: Linz
country: Austria
facility: Hauptstrasse 61
city: Mürzzuschlag
country: Austria
facility: Brauhausgasse 1
city: Voitsberg
country: Austria
facility: Conrad-von-Hötzendorf Strasse
city: Wels
country: Austria
facility: Grieskirchner Strasse 17
Study officials:
affiliation: Baxter Healthcare Corporation
name: Baxter BioScience Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02284646: Physical Training Program in Ankylosing Spondylitis
Official title: Assessment of the Efficacy of a Physical Training Program in Patients With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing spondylitis
Physical training program
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: to assess the efficacy of a physical training program in patients with ankylosing spondylitis (AS) in a randomized controlled study

Detailed description: AS is a chronic inflammatory rheumatic disorder affecting spine, peripheral joints and entheses. Patients undergo pain, stiffness and reduced mobility of spine and joints. Patients experience limitations in physical activities and reduced quality of life. Some uncontrolled studies reported benefits of physical activity in patients with AS.

The aim of the present study is to assess the efficacy of a physical training program in patients with AS.

Patients will be randomized in two parallel arms: program of personalized physical training (intervention group \[PEPc\]) or program of information about physical activity (control group \[PIAP\]).

Patients will be evaluated at 12 and 24 weeks on activity, functional and metrological scores (ASAS 20, ASAS 5/6, ASDAS, BASDAI, BASFI, BASMI); biological inflammation (CRP); NSAID use and pain VAS.

Primary outcome: percentage of patients reaching an ASAS 20 response at 12 weeks.

Secondary outcomes: ASAS 20 at 24 weeks, ASAS5/6, ASDAS, BASDAI, BASFI, BASMI, CRP, NSAID use and pain VAS at 12 and 24 weeks.

Statistical analysis: comparison of the percentage of patients reaching an ASAS 20 response at 12 weeks in each arm using a Fisher's exact test (main outcome).

Eligibility criteria: Inclusion Criteria:

* Patients with AS according to ASAS criteria,
* treated or not with NSAID,
* synthetic DMARD or anti-TNF agent.

Exclusion Criteria:

* Contraindications to physical training program (e.g. cardiac failure, pregnancy, painful arthroplasty or lower limbs damaged joint).

Primary outcomes:
measure: Percentage of patients reaching an ASAS 20 response
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of patients reaching an ASAS 20 response
timeFrame: Week 24
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: UH Toulouse
name: Arnaud constantin, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05443269: Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures
Official title: Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures of Health in Overweight and Obese Men and Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Keywords: Jump Start
USANA
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: USANA Health Sciences
First posted: 2022-07-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the proposed study is to evaluate the impact of the Jump Start program to facilitate weight loss in a sample of overweight and obese men and women. The study will not only evaluate weight loss and changes in body-shape but will also assess the type of weight lost (fat vs. lean mass) and other health measures affected by obesity including lipids, glucose, insulin, resting heart rate and blood pressure, and perceived wellness. This study will contribute to the general weight loss literature by providing evidence for or against the use of a meal replacement centered one-week weight loss program to yield weight loss and other health-specific benefits. The hypothesis is that the Jump Start program will result in an average 3-5 pound weight loss, as well as improvements in bloodborne markers of health, from day 1 to day 8.


Eligibility criteria: Inclusion Criteria:

* BMI of 28-39.9 kg/m2
* can fast \>10 hours
* maintain existing exercise regiment during study

Exclusion Criteria:

* Weight greater than 500 lbs
* Type I or II diabetic
* liver disease
* tobacco user
* adversity to fiber or protein supplement
* taking weight loss dietary supplements or adhering to any weight loss plan in the month prior to and during participation in the study
* taking a multi-vitamin or pro-biotic, or if they were not recommended by a doctor, willing to stop for 4 weeks prior to the study.
* consumption of alcohol or caffeine within 24 hours of each testing visit
* strenuous exercise during the 24 hours period before each testing visit
* self-reported active infection or illness of any kind
* pregnant or lactating

Primary outcomes:
measure: Body Composition
timeFrame: Day 8
measure: Lipids Panel
timeFrame: Day 8
measure: Glucose
timeFrame: Day 8
measure: Insulin
timeFrame: Day 8
measure: Body Weight
timeFrame: Day 8
measure: Body Mass Index
timeFrame: Day 8
measure: Resting Blood pressure
timeFrame: Day 8
measure: Resting Heart Rate
timeFrame: Day 8
measure: Subjects' perceived wellness
timeFrame: Day 8
measure: Hip Circumference
timeFrame: Day 8
measure: Waist Circumference
timeFrame: Day 8
measure: Physical Appearance
timeFrame: Day 8
Secondary outcomes:
measure: Diet
timeFrame: Day 8
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Research
state: Tennessee
Study officials:
affiliation: Research Assistant Professor
name: Jacquelyn Pence, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05514769: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer
Official title: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Proximal Gastric Adenocarcinoma
Gastric Cancer
Gastroesophageal Reflux Disease
Lead sponsor: Nanchong Central Hospital
Sponsor class: OTHER_GOV
First posted: 2022-08-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is designed to compare proximal gastrectomy anterior anastomosis with pyloroplasty with esophagogastric anastomosis for gastric cancer. Gastroesophageal reflux disease, postoperative quality of life, short term outcomes, and long term outcomes will be compared.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
2. Eastern Cooperative Oncology Group performance status of 0 or 1.
3. Adequate organ function.

Exclusion Criteria:

1. Patients had distant metastasis.
2. oesophageal invasion of more than 3 cm.
3. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
4. Previous chemotherapy or radiation therapy for any other malignancies.

Primary outcomes:
measure: Gastroesophagus reflux disease apprised by ph monitoring
timeFrame: 6 months
measure: Gastroesophagus reflux disease apprised by questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Surgical complications of proximal gastrectomy for gastric cancer
timeFrame: 1 year
measure: Long-term outcome
timeFrame: 5 years
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Yunhong Tian
state: Sichuan
Study officials:
References:
Clinical trial NCT05938569: Computer-Assisted Hair Restoration Study Using ARTAS System
Official title: Computer-Assisted Hair Restoration Study Using ARTAS System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Androgenic Alopecia
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2023-07-10
Enrollment: 150
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.


Eligibility criteria: Inclusion Criteria:

* Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of III-VI
* Subject is 20 to 70 years old
* Subject agrees to cut hair short (\< 1 mm) on the scalp in the designated study areas for harvesting and implantation
* Subject is able to understand and provide written consent
* Subject consents to post-operative follow-up per protocol

Exclusion Criteria:

* Subject has prior history of scalp reduction surgery(s) in the past six months
* Subject has bleeding diathesis
* Subject has active use of anti-coagulation medication
* Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study

Primary outcomes:
measure: Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation
timeFrame: 1 year post-treatment
Secondary outcomes:
measure: Percentage of follicles successfully harvested by Robot
timeFrame: 1 year post-treatment
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: Berman Skin Institute
state: California
city: San Jose
country: United States
facility: Le's Aesthetics
state: California
Study officials:
References:
Clinical trial NCT04339569: Landing Biomechanics Following Fatigue in Athletes With and Without a History of Patellar Tendinopathy
Official title: Full-body Landing Biomechanics Following Fatigue in Male Jumping Athletes With and Without a History of Patellar Tendinopathy: a Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patellar Tendinitis
Fatigue
Keywords: Biomechanics
Landing
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 24
Sex: MALE
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Players from sports with repetitive jump-landing manoeuvres.

Brief summary: In this case-control study, two- and three-dimensional landing biomechanics, by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), will be compared between 30 male volleyball/basketball players with a history of patellar tendinopathy and 30 healthy controls.


Eligibility criteria: Inclusion Criteria:

* volleyball or basketball players
* male
* history of patellar tendinopathy

Exclusion Criteria:

* history of surgery of the lower extremities
* history of fractures of the lower extremities

Primary outcomes:
measure: Change in landing biomechanics (kinematics and kinetics)
timeFrame: Immediately after fatiguing exercises
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Vakgroep Revalidatiewetenschappen
state: Oost-Vlaanderen
Study officials:
References:
Clinical trial NCT01935869: Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100
Official title: Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2013-09-05
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects.


Eligibility criteria: Inclusion Criteria:

* 1. Following verbal and written information about the trial, subject must provide signed and dated informed consent before any study related activities are carried out.
* 2. Healthy male or female subjects, 18 to 65 years of age inclusive at screening.

Exclusion Criteria:

* 1. Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding
* 2. Subjects with any systemic or cutaneous disorder that might interfere with the evaluation of the test site reactions (e.g. atopic dermatitis, contact eczema, psoriasis) 3. Subjects with scars, moles or other abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)

Primary outcomes:
measure: Mean Cumulative Irritation index and maximal dermal response during induction phase
timeFrame: 3 weeks
measure: Number of subjects with positive sensitisation reaction at each test site in the challenge phase
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nice Cedex 3
country: France
facility: CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital de l'Archet 2
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References:
citation: Queille-Roussel C, Liljedahl M, Clonier F, Lacour JP. Phase I evaluation of the dermal safety of the fixed combination calcipotriene plus betamethasone dipropionate aerosol foam and foam vehicle. J Am Acad Dermatol. 2015:72 Suppl 1;AB211 (P844).
Clinical trial NCT03142269: The Influences Of Anterior Capsule Polishing On Anterior Capsular Changes and Intraocular Lenses Stability of Super High Myopic Eyes
Official title: The Influences of 360° Anterior Capsule Polishing on Refraction, Anterior Capsular Opening Size and IOL Stability Among Super High Myopia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia, High, With Cataract and Anterior Capsule Polished
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A prospective study included 20 patients with super high myopia who underwent bilateral uneventful cataract. 360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye, and the opposite unpolished was used as the control. The refractive state and size of anterior opening were measured at postoperative 1 day as the baseline. Then they followed up at 1 month, 3 months and 6 months after surgery to record refractive state, higher-order aberrations, size of anterior opening, tilt and decentration of IOL (intraocular lenses)and PAD(postoperative aqueous depth). The paired t test was used to compare the differences between the two groups, and the same test the postoperative follow-up comparing with the baseline.


Eligibility criteria: Inclusion Criteria:cataract patients with super high myopia (axial length \>27mm) and difference of binocular was less than 1mm Exclusion Criteria:larger corneal astigmatism need toric intraocular lens; patients with any systemic or ocular diseases that may influence the anterior capsule opening morphologic, such as keratonosus, glaucoma, uveitis, Pseudoexfoliation syndrome, retinitis pigmentosa and diabetes and Myotonic Dystrophy, etc.; patients with ophthalmic surgery and trauma history.

Primary outcomes:
measure: refraction
timeFrame: Change from postoperative 1 day to 1 months
measure: anterior opening size
timeFrame: Change from postoperative 1 day to 1 months
measure: Stability of IOL
timeFrame: Change from postoperative 1 months to 3 months
Secondary outcomes:
measure: refraction
timeFrame: Change from postoperative 1 month to 3 months
measure: refraction
timeFrame: Change from postoperative 3 month to 6 months
measure: anterior opening size
timeFrame: Change from postoperative 1 month to 3 months
measure: anterior opening size
timeFrame: Change from postoperative 3 month to 6 months
measure: Stability of IOL
timeFrame: Change from postoperative 3 month to 6 months
Other outcomes:
Locations:
Study officials:
References: