louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00642122: Adults With Moderate to Severe Asthma
Official title: A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Pulmicort
budesonide
respules
turbuhaler
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 900
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 12 or over who have asthma
* Ability to properly use an electronic diary
* Able and willing to nebulize for up to 20 minutes every morning and evening

Exclusion Criteria:

* Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
* Planned hospitalisation during the study
* pregnant women or women planning to become pregnant

Primary outcomes:
measure: Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.
timeFrame: Day -14, 1, and every 28 days thereafter
Secondary outcomes:
measure: Percentage of symptom free days
timeFrame: Day -14, 1, and every 28 days thereafter
measure: Percentage of symptom free nights
timeFrame: Day -14, 1, and every 28 days thereafter
measure: Percentage of symptom free 24-hours
timeFrame: Day -14, 1, and every 28 days thereafter
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Bertil Andersson
role: STUDY_DIRECTOR
References:
Clinical trial NCT01479322: Plasma Adiponectin Level and Vascular Endothelial and Smooth Muscle Cell Function in Children With Prader-Willi Syndrome
Official title: Correlation Between Hyperghrelinemia and Carotid Artery Intima-Media Thickness in Children With Prader-Willi Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prader-Willi Syndrome
Obesity
Keywords: Intima-media thickness
Ghrelin
Prader-Willi syndrome
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 51
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators studied twenty-seven children with PWS and 24 normal control subjects. The groups were adjusted for age, sex, and BMI.

Brief summary: Context: Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset obesity and endocrine dysfunction that leads to cardiovascular disability and early death within the first 3 decades of life.

Objectives: To assess the significance of risk factors for future disabilities, carotid artery intima-media thickness (IMT) was measured and correlated with known atherosclerotic risk factors in 27 children with PWS and 24 age-, sex-, and body mass index (BMI)-adjusted controls.

Detailed description: Main outcome measures: Correlation of IMT with age, standard deviation score of BMI (BMI-SDS), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), C-reactive protein, HOMA-IR and ghrelin.

Eligibility criteria: Inclusion Criteria:

* obesity with PWS

Exclusion Criteria:

* chronic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Dong-Kyu Jin, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00841022: Information and Anaesthesia in Paediatrics
Official title: Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: anxiety
anaesthesia
child
RCT
Elective surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-02-11
Enrollment: 115
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.

Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia visit or no intervention.

Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.


Eligibility criteria: Inclusion Criteria:

* Male or female children between 6 to 16 years and 11 month old.
* Children scheduled to have a craniotomy or orthopaedic surgery (multi-level surgery, spinal decompression, osteosarcoma resection, column surgery , fibroid curettage, Nuss bar procedure, hip varus surgery) or visceral and urologic surgery (intestinal continuity restoration, hypospadias surgery, bladder malformation, sarcoma).
* Children with a high, normal or light level of verbal comprehension (normal academic level or less than two repeating).
* Children coming with their parents.

Exclusion Criteria:

* Previous surgery.
* Unwillingness to participate (parents or child)

Primary outcomes:
measure: Level of anxiety scale (STAIC-S)
timeFrame: before preanaesthesia consultation and after preanaesthesia consultation
Secondary outcomes:
measure: Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension)
timeFrame: before preanaesthesia consultation
measure: Level of anxiety scale (STAIC-T)
timeFrame: Before preanaesthesia consultation
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Edmundo PEREIRA DE SOUZA NETO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kassai B, Rabilloud M, Dantony E, Grousson S, Revol O, Malik S, Ginhoux T, Touil N, Chassard D, Pereira de Souza Neto E. Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children. Br J Anaesth. 2016 Jul;117(1):95-102. doi: 10.1093/bja/aew154.
Clinical trial NCT03992222: Prevention of the Older Adult's Loss of Autonomy at Home Through a Targeted Physical Exercise Program
Official title: Prevention of the Older Adult's Loss of Autonomy at Home Through a Physical Exercise Program Targeted at Adapted Muscle Strengthening Devices
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autonomy of Older People
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 280
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Physical exercise program (PEP) have demonstrated their benefit to the health of older people. They are effective in functional performance and in the incidence and severity of falls.

We hypothesize that intervention with targeted Physical exercise programs PEP on appropriate muscle strengthening devices allows, through its action on the muscle, to slow down the loss of autonomy in the elderly living in the home. Our main objective is to evaluate the impact of a PEP, targeted on adapted muscle strengthening devices, on the loss of autonomy for the acts of daily life in the person aged over 70 living at home.

Detailed description: The elderly will be identified during their call in the home centers of the town halls to get a housekeeper. After information, inclusion and randomization into two groups in the consultation site, the intervention group volunteers will follow the PEP for 24 weeks; the control group volunteers will receive a counseling booklet. Both groups will be followed at week 24 and 52.

Eligibility criteria: Inclusion Criteria:

* People over 70 years old
* Living at home
* With at least one instrumental activity of altered daily life (a disturbed criterion on the IADL scale) and making a request to set up a housekeeper.
* Major, able to give their consent
* Having signed the informed consent
* Affiliation to a social security scheme,

Exclusion Criteria:

* Surgical procedure within 6 months on the hip or knee,
* myocardial infarction or cerebrovascular accident diagnosed within 6 months,
* Respiratory insufficiency requiring long-term oxygen therapy
* Heart failure requiring hospitalization in the previous month or considered severe by the cardiologist
* Known or disabling muscle or joint pathology
* Subject benefiting from rehabilitation through physiotherapy sessions in progress or not wishing to stop physical exercise workshops
* Subject already in loss of autonomy for the ADL
* Life expectancy of less than 6 months any cause combined

Primary outcomes:
measure: Percentage of people without activities of daily living (LDA) assessed by the 12-month Katz questionnaire in the intervention group compared to the control group.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sevran
country: France
facility: Hopital René Muret
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Véronique FRANCOIS, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05524922: A Registered Cohort Study on Neurodegenerative Associated With Sleep Disorder.
Official title: A Registered Observational Cohort Study on Neurodegenerative Associated With Sleep Disorder.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurodegenerative Disorder
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurodegenerative disorders are a cluster of chronic progressive diseases characterized by specific pathological manifestations. Common neurodegenerative disorders include Alzheimer's disease, Parkinson's disease and so on. We studied people with sleep disorders associated with neurodegenerative disorders.

Brief summary: Cognitive impairment often appears in neurodegenerative diseases, and it is expected to further study the mechanism of sleep disorders associated with the progression of neurodegenerative diseases by exploring the clinical manifestations, imaging, and biological marker changes of sleep disorders in neurodegenerative diseases.


Eligibility criteria: Inclusion Criteria:

1. clinical diagnosis of neurodegenerative disease.
2. patients experience insomnia, excessive drowsiness, or confusion at night.
3. Patients experience frequent awakenings, daily sleep episodes, or nocturnal confusion.
4. The presence of one or more of the following characteristics: a. wandering at night with inappropriate activity; b. agitation, combativeness; c. confusion, disorientation, or marked delirium.
5. Polysomnographic monitoring showed the following two conditions: a. poor sleep efficiency, increased number and duration of awakenings; b. multiple sleep latency tests showed increased daytime sleepiness.
6. Presence of other medical symptoms that do not indicate the primary disease.
7. Other sleep disorders (e.g., periodic limb movement disorders, obstructive sleep apnea syndrome) may be present, but do not explain the patient 's main symptoms.
8. any of the above can be diagnosed

Exclusion Criteria:

1. Patients with other neurological disorders.
2. Pregnant or lactating women.

Primary outcomes:
measure: PSQI Scores
timeFrame: Baseline
Secondary outcomes:
measure: MoCA scores
timeFrame: Baseline
measure: ACE-III scores
timeFrame: Baseline
measure: HRV (ms)
timeFrame: Baseline
measure: Plasma Aβ-42 levels (ng/ml)
timeFrame: Baseline
measure: Vic
timeFrame: Baseline
measure: PAF (Hz)
timeFrame: Baseline
measure: Vic
timeFrame: 1 year after baseline
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT02507622: E-NOSE for Breath Gas Analysis Under Microgravity Conditions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main goal of the study is demonstrate that e-Nose system function is not altered in weightlessness and more specifically that gas concentration measurements are the same in weightlessness and normal gravity.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 20 to 65
* Affiliated to a French Social Security system or, for people living abroad, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who has given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Pregnant women

Primary outcomes:
measure: The judgment criteria are the concentration of C02, CO and NH4, 3 exhaled gas
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References:
Clinical trial NCT03071939: Cognate Patient Care Insight Scale
Official title: Pilot Study of a New Insight Assessment Tool
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One arm in this study comprising 119 patients and one of their relatives
Primary purpose: OTHER

Brief summary: Schizophrenia is a disease of young adults that affects 1% of the general population. According to numerous studies, it has been estimated that between 50% and 80% of patients with schizophrenia do not consider to have a mental disorder and are therefore not aware of their disorders. A poor degree of insight is associated with poor compliance, a higher number of re-hospitalizations, altered social and relational functioning, and a higher number of suicides and violent behaviors. This is why insight, which is an essential dimension of psychopathology, must be evaluated, as it depends to a large extent on the therapeutic alliance, adherence to treatment, likelihood of relapse and prognosis.

Detailed description: Evaluation (test, re-test) This new tool for assessing insight will allow for a discrepancy in assessment and a more refined assessment with a view to developing specific care for the patient and / or the relative with regard to the three dimensions Evaluated: disease, treatment and functional implications

Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia
* Age from 18 to 50 years old
* Stabilized clinical condition (without therapeutic modification during the month prior to inclusion)
* French language read, spoken and understood (patient and family member)
* Having given his consent
* Agreement of the guardian for persons under guardianship
* Consent of the relative

Exclusion Criteria:

* Refusal of patient or legal guardian
* Refusal of the loved one
* Patient and / or neurological disorder of neurological origin of vascular, infectious or neurodegenerative origin

Primary outcomes:
measure: Concurrent validity of the hetero-evaluation scale by studying its correlation with the results obtained, for the same persons, on the SUMD scale (Scale to Assess Unawareness of Mental Disorder)
timeFrame: two years
Secondary outcomes:
measure: Correlation greater than 0.40 to inter-judge fidelity to Cohen's Kappa test
timeFrame: two years
measure: Cronbach's alpha coefficient with a value of 0.7 measuring internal consistency
timeFrame: two years
measure: Correlation greater than 0.40 at the Bravais-Pearson test measuring test fidelity, re-testing
timeFrame: two years
Other outcomes:
Locations:
city: Bron Cedex
country: France
facility: Centre Hospitalier Le Vinatier
Study officials:
affiliation: Centre Hospitalier le Vinatier
name: MAGES Nicolas, MDPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00391339: Bryophyllum vs. Nifedipine
Official title: Bryophyllum p. Versus Nifedipine for the Treatment of Premature Contractions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Tocolysis
Keywords: Bryophyllum p.
Nifedipine
Tocolysis
Lead sponsor: Weleda AG
Sponsor class: INDUSTRY
First posted: 2006-10-23
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a prospective, randomised study the efficacy and tolerability of bryophyllum p. (p.o) vs. nifedipine (p.o) will be proofed in a defined group of pregnant women with threatened preterm labour.


Eligibility criteria: Inclusion Criteria:

* Female

Exclusion Criteria:

* Bishop Score \> 5

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zuerich
country: Switzerland
facility: Department of Obstetrics, University of Zuerich
Study officials:
affiliation: Department of Obstetrics, University Zuerich
name: Roland Zimmermann, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plangger N, Rist L, Zimmermann R, von Mandach U. Intravenous tocolysis with Bryophyllum pinnatum is better tolerated than beta-agonist application. Eur J Obstet Gynecol Reprod Biol. 2006 Feb 1;124(2):168-72. doi: 10.1016/j.ejogrb.2005.05.013. Epub 2005 Jul 26.
citation: Gwehenberger B, Rist L, Huch R, von Mandach U. Effect of Bryophyllum pinnatum versus fenoterol on uterine contractility. Eur J Obstet Gynecol Reprod Biol. 2004 Apr 15;113(2):164-71. doi: 10.1016/S0301-2115(03)00370-1.
citation: Vilaghy I. [Decreasing the rate of premature delivery with phytotherapy--results from general practice]. Ther Umsch. 2002 Dec;59(12):696-701. doi: 10.1024/0040-5930.59.12.696. German.
Clinical trial NCT06376539: Functional Recovery of Patients Undergoing Resection and Reconstruction of the Lower Limbs for Bone Tumor.
Official title: Functional Recovery in the First Six Postoperative Months of Cancer Patients Undergoing Lower Limb Resection and Reconstruction. An Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Neoplasm
Rehabilitation
Keywords: bone tumor
physiotherapy
functional recovery
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants with bone tumor diagnosis treated at the hospital

Brief summary: The aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved.

Detailed description: Retrospective observational study will be conducted. The evaluation of the patients clinical recovery progress will take place at three different times: during the hospital stay postoperative, at 3 and 6 months after surgery. Different outcome measures will be considered in order to provide a complete picture of the patients functional recovery and their change.

Eligibility criteria: Inclusion Criteria:

* All participants undergone lower limb resection and reconstruction with localisation of the disease to the pelvis, femur femur, tibia and foot bones.
* All participants undergone soft tissue resection surgery on the of the lower limb
* All types of oncological diagnoses will be taken considered: osteosarcoma, Ewing and others.

Exclusion Criteria:

* Participants who undergo at our Institute only the surgical treatment while continuing adjuvant treatment at other centres
* Participants for whom no rehabilitation treatment has been activated during adjuvant treatment at our Institute

Primary outcomes:
measure: Toronto Extremity Salvage Score (TESS)
timeFrame: at 3 months after surgery
measure: Toronto Extremity Salvage Score (TESS)
timeFrame: at 6 months after surgery
Secondary outcomes:
measure: Range of motion (ROM)
timeFrame: at 3 months after surgery
measure: Rang of motion - 2 (ROM)
timeFrame: at 6 months after surgery
measure: Number of participants able to walk
timeFrame: up to 1 week
measure: Time Up and Go -2 (TUG)
timeFrame: at 3 months after surgery
measure: Time Up and Go (TUG)
timeFrame: at 6 months after surgery
measure: Muscle Strength
timeFrame: at 3 months after surgery
measure: Muscle Strength-2
timeFrame: at 6 months after surgery
measure: Number of day from surgery to first walking
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT01964339: Obesity Hypoventilation Syndrome Prevalence Study
Official title: Obesity Hypoventilation Syndrome Prevalence Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity Hypoventilation Syndrome
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with a BMI greater than or equal to 30kg/m2 scheduled for a routine polysomnograpy (PSG) test. Participants will be recruited from pulmonology clinics or referred to the sleep lab via hospital admissions.

Brief summary: This is an observational study to characterize the prevalence of Obesity Hypoventilation Syndrome in patients referred to the sleep lab.


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 21 yrs. of age
* Referred to sleep lab for diagnostic PSG, initial titration PSG or split night PSG as routine clinical care
* BMI greater than or equal to 30kg/m2

Exclusion Criteria:

* Acutely ill or medically unstable to participate per PI
* Current positive airway pressure(PAP therapy)users
* Medical History of Chronic Obstructive Pulmonary Disease(COPD)
* Incapable of providing own informed consent
* BMI less than 30kg/m2

Primary outcomes:
measure: Baseline venous blood draw
timeFrame: single blood draw
Secondary outcomes:
Other outcomes:
measure: Standard polysomnography (PSG) variables
timeFrame: once
measure: Key demographic characteristics will be collected.
timeFrame: once
Locations:
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Center
state: Louisiana
Study officials:
References: