louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04528433: A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With ADHD
Official title: A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study will be carried out using a parallel randomized study design. Each participant will be randomly assigned either to the collaborated intervention or to the routine clinical care control group.
Primary purpose: TREATMENT

Brief summary: This study is designed to test if the medical-education-community collaborated intervention can reduce the symptoms of children with Attention deficit hyperactivity disorder (ADHD) compared to routine clinical care. Investigators will also evaluate if the intervention will positively affect organizational skills and academic achievement compared to controls.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with ADHD
* Doctor rated SNAP-IV Inattention of Hyperactivity/Impulsivity score\>12
* Full-Scale Intelligence Quotient\>=80 (Wechsler intelligence scale for children-IV)

Exclusion Criteria:

* Accepting any type of psychological treatment during the intervention
* Comorbid with epileptic disorder or other existing physical disorder, Tourette syndrome, Autism Spectrum Disorder, learning disorder, mood disorder, psychiatric disorder, or under suicidal risk
* Attending any other clinical research at the same time

Primary outcomes:
measure: total score change in SNAP-IV scale
timeFrame: Baseline, 3 months after enrollment
Secondary outcomes:
measure: total score change in Behavior Rating Inventory of Executive Function scale
timeFrame: Baseline, 3 months after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychological Medicine, Children's Hospital of Fudan University
name: Mengyao Li, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03173833: Fulfilling Care Needs of Adolescents With Cancer
Official title: Fulfilling Care Needs of Adolescents With Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: cancer patients, quality of life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 720
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of phase 1 of this study is to develop a care need scale (CNS) for adolescents with cancer. The aim of phase 2 is to examine the mediating role of care needs between physical and psychosocial dysfunction and QoL, and to explore the recovery trajectory and its predictors regarding the care needs, physical and psychosocial factors, and the QoL of adolescents with cancer at the first, second, and third 3-month periods after initiating on-treatment and off-treatment. The aim of phase 3 is to examine the effectiveness of the computerized assessment with graphic outcome (CAGO) for fulfilling the care needs of adolescents with cancer, its acceptability for adolescents with cancer, and its usability for clinicians in pediatric oncology units.


Eligibility criteria: The inclusion criteria for adolescents with cancer are

1. 13-20 years of age
2. previously or currently treated for cancer
3. able to communicate in Chinese
4. able to comprehend the study information

Primary outcomes:
measure: Symptom Distress Scale
timeFrame: 2 weeks
measure: Beck Youth Inventories second edition
timeFrame: 2 weeks
measure: Posttraumatic Growth Index
timeFrame: 2 weeks
measure: Resilience Scale
timeFrame: 2 weeks
measure: Care demand scale
timeFrame: 2 weeks
measure: Pediatric Quality of Life
timeFrame: 2 weeks
measure: Acceptability if E-scale
timeFrame: 2 weeks
measure: Usability scale
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Test1
country: Taiwan
facility: National Taiwan University Hospital
state: Test2
Study officials:
affiliation: National Taiwan University Hospital Department of Pediatrics
name: SHIANN-TARNG LOU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06802133: Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)
Official title: Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Repair of Dura Mater
Lead sponsor: Collagen Matrix
Sponsor class: INDUSTRY
First posted: 2025-01-31
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The general population will be included in the study where a dura substitute is required for the repair of dura mater

Brief summary: Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.

Detailed description: A prospective, post-market, open label clinical study at a maximum of 8 sites, with an enrollment of 118 subjects. The primary endpoint of the study will be the rate of revision surgery. The presence of adverse events will be evaluated at each follow-up time point i.e. CSF leak, infection and Pseudomeningocele. Patients will have a follow-up evaluation at least at 8 weeks post initial surgery date (which align with the approximate resorption time of the device) where possible and as deemed necessary by a clinician.

No original patient records or personal identifying information will be disclosed to Collagen Matrix.

Eligibility criteria: Inclusion Criteria:

* The general population will be included in the study where a dura substitute is required for the repair of dura mater.

Exclusion Criteria:

* Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.

Primary outcomes:
measure: Rate of Revision Surgery
timeFrame: 8 weeks
Secondary outcomes:
measure: Rate of Adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01954654: Effectiveness of Accelerated Intervention With Compression Sleeve in Mild and Moderate Breast Cancer-related Lymphedema
Official title: Effectiveness of Accelerated Intervention With Custom-made Compression Sleeve in Women With Mild and Moderate Arm Lymphedema Secondary to Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lymphedema
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether accelerated treatment with custom-made compression sleeve is more effective than standard procedure in the treatment of mild and moderate arm lymphedema secondary to primary cancer treatment.

Detailed description: Use of a custom-made compression sleeve is an initial treatment of mild and moderate arm lymphedema secondary to primary breast cancer treatment. The compression sleeve improves the flow of lymph fluid out of the arm, reduces the swelling, and prevents progression of the lymphedema in the future.

Early intervention is recommended though early is not well-defined in literature. The purpose of this study is to evaluate reduction of excess limb volume and changes in arm disability and clinical symptoms in accelerated treatment with compression sleeve compared to standard treatment.

Eligibility criteria: Inclusion Criteria:

* Participants must be refered for the first time due to unilateral arm lymphedema secondary to primary unilateral breast cancer treatment
* Participants must be ≥ 2 months after chemo- and radiotherapy
* Participants must have ELV ≥10% and \< 30% and/or \> 2 cm difference between the circumference of the two arms at minimum one circumference due to lymphedema
* Participants must be motivated for treatment with compression sleeve and -gauntlet
* Participants live in and around Aarhus, Denmark

Exclusion Criteria:

* Known metastatic disease
* Contraindication for treatment with compression sleeve
* Upper extremity deep venous thrombosis
* Previously use of compression sleeve
* Known contact allergy to latex
* Unable to fill in questionnaire and/or comply with treatment due to lacking Danish language skills, mental state or psychological condition

Primary outcomes:
measure: Change of excess limb volume (ELV)
timeFrame: 8 weeks follow-up
Secondary outcomes:
measure: Changes in arm disability
timeFrame: 8 weeks follow-up
measure: Changes in subjective symptoms (pain, tension, and heaviness)
timeFrame: 8 weeks follow-up
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Fysioterapi- og Ergoterapisfdelingen
Study officials:
References:
Clinical trial NCT05260554: Effect of Cranberry Extract on the Urinary System
Official title: Effects of Use of Cranberry Extract Instead of Antibiotics During Uncomplicated Urinary Tract Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Disease
Cystitis
Antibiotic Reaction
Keywords: Urinary Tract Disease
Cranberry extract
Antibiotic
Cystitis
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Among the patients who were eligible criteria, the study was terminated when the number of patients in both groups reached 80.

Brief summary: In this study, we will try to emphasize the effects of using cranberry tablets, which is an alternative to antibiotic therapy, during uncomplicated urinary tract infections (only urinary tract, bladder and kidney infections did not).

Detailed description: This study was Istanbul Kartal Dr. Lütfi Kırdar Training and Research Hospital Emergency Medicine Clinic and Kırklareli Training and Research Hospital Emergency Service and Internal Medicine Polyclinic. Our study; includes patients who applied to the Emergency Department and Internal Medicine outpatient clinic with the complaint of dysuria and had normal WBC, CRP, urea, and creatinine values in their analysis, and leukocyturia was found in the urine test. Two options were offered in the treatment to these patients. Vaccinium Macrocarpon Aiton preparation or fosfomycin was given for seven days. The patients were asked whether their complaints had decreased according to the Lykert-Type verbal scale at the time of admission and on the first, third, and seventh days. When the treatment was finished, leukocytes were checked in the urinalysis. This outcome was compared between the 2 treatment options. We also noted whether nausea.

Eligibility criteria: Inclusion Criteria:

* Older than 18
* who have urinary tract inflammation
* who haven't kidney dissease previous

Exclusion Criteria:

* Younger than 18
* Who have kidney inflammation
* Pregnant patients
* Who have blood test abnormal (WBC, Ure, Creatin, CRP high level)

Primary outcomes:
measure: Treatment time
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kirklareli
country: Turkey
facility: Oya Guven, MD
state: Center
Study officials:
affiliation: Kırklareli University
name: Oya Guven
role: STUDY_DIRECTOR
References:
citation: Gray M. Are cranberry juice or cranberry products effective in the prevention or management of urinary tract infection? J Wound Ostomy Continence Nurs. 2002 May;29(3):122-6. doi: 10.1067/mjw.2002.124016. No abstract available.
Clinical trial NCT04162054: Observation of Acute Cardiopulmonary Effects in Healthy Individuals Performing Cardiopulmonary Exercise Test (CPX) During Whole Body Vibration (WBV)
Official title: Observation of Acute Cardiopulmonary Effects in Healthy Individuals Performing Cardiopulmonary Exercise Test (CPX) During Whole Body Vibration (WBV)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Cardiopulmonary Effects
Lead sponsor: Klinikum der Universität Köln
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * healthy individuals planning on performing a WBV-Training
* healthy individuals planning on performing a CPX

Brief summary: Observational study to evaluate acute cardiopulmonary effects of oscillatory whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).

Detailed description: Oscillatory whole-body vibration (WBV) is a novel exercise modality, which is performed on a vibrating platform that moves in sinusoidal oscillations, and during which static and dynamic exercises can be performed. Rapid movements of the platform lead to muscle spindle reﬂexes, which result in reﬂectory contraction of muscle groups and thus promote gain of muscle strength and power. The most efﬁcient vibration rate enhancing muscle function is assumed to be ∼20 Hz, leading to constant muscle contraction and anaerobic metabolism of the affected muscle ﬁbres. As a consequence, lactate liberation serves as a stimulus for muscle gain.This methodology has been successfully utilised to enhance moving velocity, muscle power and strength in young athletes and chronic obstructive pulmonary disease though not been understood in all details. Therefore this investigation will help to evaluate acute cardiopulmonary effects of whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).

Eligibility criteria: Inclusion Criteria:

* healthy individuals planning on performing a WBV-Training
* healthy individuals planning on performing a CPX

Exclusion Criteria:

* exclusion to perform CPX
* exclusion to perform WBV

Primary outcomes:
measure: Peak VO2 in mililiter
timeFrame: one day
Secondary outcomes:
measure: Nadir Co2 at anaerobic threshold
timeFrame: one day
measure: anaerobic threshold (AT)
timeFrame: one day
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Spezialambulanz für pulmonale Hypertonie Uniklinik Köln
state: NRW
Study officials:
References:
citation: Gerhardt F, Dumitrescu D, Gartner C, Beccard R, Viethen T, Kramer T, Baldus S, Hellmich M, Schonau E, Rosenkranz S. Oscillatory whole-body vibration improves exercise capacity and physical performance in pulmonary arterial hypertension: a randomised clinical study. Heart. 2017 Apr;103(8):592-598. doi: 10.1136/heartjnl-2016-309852. Epub 2017 Jan 18.
Clinical trial NCT05113654: Sleep Disorders in Idiopathic Pulmonary Fibrosis
Official title: Sleep Disorders in Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2021-11-09
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants were recruited from clinical routine patients.

Brief summary: This diagnostic observational study was conducted to (1) investigate the prevalence of sleep-related breathing disorders and other sleep disorders in idiopathic pulmonary fibrosis in comparison to COPD, (2) identify characteristics of symptomatic and prognostic significance in idiopathic pulmonary fibrosis with/without sleep disorders, and (3) evaluate different tools for their ability to assess the risk of co-existing sleep disorders in idiopathic pulmonary fibrosis.


Eligibility criteria: Inclusion Criteria:

* Age \>=18 years
* written informed consent
* IPF cohort: Documented history of IPF with definite or possible UIP pattern and signs of emphysema below 10% by HRCT (IPF diagnosis according to 2011 ATS/ERS IPF guidelines)
* COPD cohort: Documented history of COPD Stage II Group A or B, Stage III or IV, Group C or D (GOLD 2014)

Exclusion Criteria:

* Long-term oxygen therapy
* Heart failure NYHA stages III and IV
* Left ventricular ejection fraction ≤ 45%
* Pregnancy and/or lactation
* Acute and/or life-threatening illness (instable angina pectoris, acute pulmonary arterial embolism, myocardial infarction, malignant tumor requiring treatment)
* Current drug or alcohol abuse
* Any medical, psychological or other condition impairing the patient's ability to provide informed consent
* IPF cohort: Acute exacerbation of IPF
* IPF cohort: Concomitant lung/airway diseases other than IPF (signs of emphysema \>10% by HRCT)
* COPD cohort: Acute exacerbation of COPD
* COPD cohort: Concomitant lung/airway diseases other than COPD (e.g. Asthma bronchiale)
* Healthy cohort: Documented history of structural airway or lung disease

Primary outcomes:
measure: Number of patients with any kind of sleep disorder according to the International Classification of Sleep Disorders (ICSD-3)
timeFrame: For individual assessment of sleep disorders: one night (between 5 and 9 hours), for overall number of patients: entire study duration (37 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Wissenschaftliches Institut Bethanien e.V.
state: NRW
Study officials:
affiliation: Wissenschaftliches Institut Bethanien e.V
name: Winfried Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01507454: Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency
Official title: Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Postmenopausal Vaginal Atrophy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-11
Enrollment: 1613
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with atrophic vaginitis caused by estrogen deficiency prescribed with Vagifem® by their treating physician

Brief summary: This study is conducted in Europe. The aim of this study is to investigate the self-reported impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.


Eligibility criteria: Inclusion Criteria:

* Atrophic vaginitis due to estrogen deficiency
* Post-menopausal

Primary outcomes:
measure: Percentage of subjects reporting vaginal symptoms occuring 'often' and 'frequently'
measure: Percentage of subjects reporting 'moderate' and 'severe' vaginal symptoms
Secondary outcomes:
measure: Adverse events
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Stute P. Urogenitale Beschwerden und Östradioltherapie: Auswirkung einer vaginalen niedrig dosierten Östradioltherapie auf die Prävalenz und Intensität von urogenitalen Beschwerden. Gynäkologische Endokrinologie 2008; 6 (1): 48-52
Clinical trial NCT02503254: Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.
Official title: A Randomized, Controlled, Open-label, 2-arm Parallel Group, Single Center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Healthy Smokers Switching to the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) Compared to Continuing to Use Conventional Cigarettes During 5 Days in Confinement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Modified risk tobacco product
Conventional cigarette
Reduced exposure
Confinement
Carbon Heated Tobacco Product
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2015-07-20
Enrollment: 85
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0 (CHTP 1.0) as compared to smokers continuing to use CC.


Eligibility criteria: Inclusion Criteria:

* Subject is aged ≥ 21 years.
* Subject is Caucasian.
* Subject is healthy, as judged by the Investigator.
* Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for at least the last 6 weeks prior to admission, based on self-reporting.
* Subject has smoked at least for the last 3 years.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.

Primary outcomes:
measure: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
timeFrame: 5 days
measure: Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
timeFrame: 5 days
measure: Concentration of S-phenylmercapturic Acid (S-PMA)
timeFrame: 5 days
measure: Levels of Carboxyhemoglobin (COHb)
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kajetany
country: Poland
facility: BioVirtus Research Site Sp. z o.o.
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
affiliation: BioVirtus Research Site
name: Katarzyna Jarus-Dziedzic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tran CT, Bosilkovska M, de La Bourdonnaye G, Blanc N, Haziza C. Reduced levels of biomarkers of exposure in smokers switching to the Carbon-Heated Tobacco Product 1.0: a controlled, randomized, open-label 5-day exposure trial. Sci Rep. 2020 Nov 5;10(1):19227. doi: 10.1038/s41598-020-76222-y.