louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00379002: The Women's Urology Center/WISH Database Project
Official title: The Women's Urology Center/WISH Database Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Cystitis
Sexual Dysfunction
Pelvic Pain
Incontinence
Keywords: Interstitial Cystitis
Sexual Dysfunction
Vulvodynia
Pelvic Pain
incontinence
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2006-09-21
Enrollment: 2923
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Women's Urology Center or WISH patients

Brief summary: Comprehensive database from the Women's Urology Center/WISH (Women's Initiative for Pelvic Pain and Sexual Health) program at Beaumont.

Detailed description: This women's health database will help us to identify health issues/concerns, useful therapies and interventions, and identify areas for improvement or further research specific for women's health. It will allow evaluation of outcomes of clinical interventions to enhance the care and treatment of women with pelvic pain and sexual health concerns.

Eligibility criteria: Inclusion Criteria:

All Women's Urology Center or WISH patients will be included in this database over time.

Exclusion Criteria:

The only exclusion would be if specified by a patient upon consent to treatment in the Women's Urology Center or WISH program

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospital Royal Oak
name: Kenneth M Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00830102: Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients
Official title: A Randomized, Placebo-controlled, Double-blind, Six-way Crossover, Single-dose Exposure Study to Compare the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™100/10μg and 250/10μg) in a Single Inhaler (SkyePharma HFA MDI) With the Administration of Fluticasone (250μg) and Formoterol (12μg) Concurrently or Alone in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Mild to Moderate Asthma
Lead sponsor: SkyePharma AG
Sponsor class: INDUSTRY
First posted: 2009-01-27
Enrollment: 64
Sex: ALL
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: The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.


Eligibility criteria: Inclusion Criteria:

* Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid

Exclusion Criteria:

* Smoking history within the last 12 months
* No history of respiratory tract infection within 4 weeks
* No history or evidence of any clinically significant disease or abnormality

Primary outcomes:
measure: Change from Baseline in Actual FEV1, % change from Baseline in Actual FEV1, change from Baseline in FEV1 % predicted normal, FEV1 max and FEV1 AUC above the Baseline
timeFrame: pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose
Secondary outcomes:
measure: Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs
timeFrame: 10 weeks including pre- and post-study assessments
Other outcomes:
Locations:
city: Belfast
country: Ireland
facility: Investigational site
city: Derbyshire
country: United Kingdom
facility: Investigational site
city: London
country: United Kingdom
facility: Investigational site
city: Manchester
country: United Kingdom
facility: Investigational site
city: Plymouth
country: United Kingdom
facility: Investigational site
city: Slough
country: United Kingdom
facility: Investigational site
Study officials:
affiliation: SkyePharma AG
name: SKP
role: STUDY_DIRECTOR
References:
Clinical trial NCT02556502: 18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study
Official title: 18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyloid PET Imaging
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The diagnosis of Alzheimer's disease (AD) is based on clinical and neuropathological criteria.

Some patients have a contributive CSF biology to determinate a high level risk of AD (Tau + phospho-tau ratio increased and Ab42 / decreased Aβ40), but others have an intermediate CSF biology (Tau and/or phospho-tau increased but Ab42 ratio / normal Aβ40) and are unclassifiable.

18F-Florbetaben (Neuraceq®), a radioisotope in positron emission tomography (PET), selectively binds to amyloid plaques, with high detection sensitivity (98%).

Detection of amyloid plaques by PET imaging separate patients according to the criteria of Dubois, as with AD and allow them to benefit a cholinesterase inhibitor treatment.

If negative, the diagnosis of AD can be excluded with a high level of confidence to prevent initiating unnecessary treatment, expensive for the community.

This is the first imaging study of amyloid plaques targeting population whose diagnosis of AD is uncertain according to the CSF biology.

The aim of this study is to describe the results of amyloid PET in case of intermediate CSF biology and to separate patients as AD or not according to the criteria of Dubois


Eligibility criteria: Inclusion Criteria:

* Major subjects who have given their consent to participate in the study.
* Patients with suspected AD and whose CSF markers give intermediate results (CSF punction less than 6 months): meaning tau and/or phospho-tau increased and Ab42 / Aβ40 normal (Ab42 / Aβ40 \> 0.07).
* Non-indication to perform a PET 18F-Florbetaben.
* Affiliation to the french social security .

Exclusion Criteria:

* Patients under guardianship.
* Inability to perform a PET 18F-Florbetaben (agitated patient, confused, ..).
* Pregnancy, lactation.

Primary outcomes:
measure: number of positive or negative amyloid PET
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT00463502: The Effect of Metformin Treatment on Thyroid Hormone Metabolism in Euthyroid Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: The purpose of study was investigated the effect of
metformin on thyroid hormone metabolism in euthyroid patients
with type 2 DM. The results revealed significant decreases
in TSH and fT4
Lead sponsor: Haydarpasa Numune State Hospital
Sponsor class: OTHER
First posted: 2007-04-20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Aim: To investigate the effects of metformin treatment on thyroid hormone metabolism in euthyroid patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* The patients included in this study were the ones who were newly diagnosed with type 2 diabetes mellitus

Exclusion Criteria:

* Presence of thyroid disorders, positive thyroid autoantibodies and usage of medications affecting thyroid hormones such as amiodarone, lithium were accepted as exclusion criterions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unaffiliation
name: Ali Ozdemir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06346002: Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children
Official title: Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children: Results From a Randomized Cluster Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness-based Intervention
Elementary School Children
Mental Health Wellness 1
Lead sponsor: Bishop's University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 231
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized cluster trial with a wait-list control
Primary purpose: PREVENTION

Brief summary: Background: Prevention programs for children such as mindfulness-based interventions (MBIs) are often implemented in schools to prevent psychological disorders from emerging and contribute to children' mental health.

Aim: This study used a randomized cluster design and assessed the impact of a MBI on well-being and mental health of elementary school children's.

Method: 13 elementary school classrooms were randomly allocated to the experimental condition (7 classrooms, n = 127 students) or the waitlist control condition (6 classrooms, n = 104 students). Participants in the experimental condition received a 10-week MBI.


Eligibility criteria: Inclusion Criteria:

* Attending the Préville Elementary School
* Spoke sufficient French to fill out questionnaires

Exclusion Criteria:

* Not attending the Préville Elementary School
* Level of French was not good enough to fill out questionnaires

Primary outcomes:
measure: Symptoms of Mental Health Disorders
timeFrame: Baseline, post-intervention (10 weeks)
measure: Basic Psychological Needs Satisfaction
timeFrame: Baseline, post-intervention (10 weeks)
measure: Process Measure
timeFrame: Baseline, post-intervention (10 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Lambert
country: Canada
facility: École primaire Préville
state: Quebec
Study officials:
References:
Clinical trial NCT04757402: Role of Preoperative Counselling With NSQIP Surgical Risk Calculator
Official title: Role of Preoperative Counselling With NSQIP Surgical Risk Calculator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction, Patient
Keywords: NSQIP Surgical risk calculator
Preoperative counselling
Anxiety
Lead sponsor: Nepal Mediciti Hospital
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Surgical patients undergo preoperative counseling which varies in quality and duration. Proper communication during the preoperative consultation can deliver relevant health information and guide improvement of perioperative health status. The methods, however, are non-standardized and the explanation of the postoperative course is generally vague or varies from person to person. We hypothesize that high-risk patients who receive pre-operative counseling with the help of the NSQIP surgical risk calculator compared to the current standard of care will have higher satisfaction concerning information on the perioperative journey.

Detailed description: The control arm will receive standard preoperative counselling and written consent will be taken.

The NSQIP arm will receive standard preoperative counselling along with the details provided by NSQIP Surgical risk calculator and written consent will be taken.

Anxiety among the patients will be accessed with the use of Preoperative anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire written in Nepali.

Duration of counselling period will be noted from the start of counselling session till the consent is signed.

Eligibility criteria: Inclusion Criteria:

* ASA III or above and/or age above 65 high-risk surgical patients undergoing surgery at Nepal Mediciti Hospital

Exclusion Criteria:

* Adults who cannot consent Pregnant women Non-Nepali speakers Consent by surrogate

Primary outcomes:
measure: The difference in patient satisfaction as assessed by a 7-point Likert scale
timeFrame: 5 MONTHS
Secondary outcomes:
measure: Preoperative anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire written in Nepalese
timeFrame: 5 months
measure: Duration of counseling
timeFrame: 5 months
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Bikash Khadka
state: Bagmati
Study officials:
affiliation: Nepal Mediciti Hospital
name: Apurb Sharma, MD
role: STUDY_CHAIR
References:
citation: Sigdel S, Ozaki A, Basnet M, Kobashi Y, Pradhan B, Higuchi A, Uprety A. Anxiety evaluation in Nepalese adult patients awaiting cardiac surgery: A prospective observational study. Medicine (Baltimore). 2020 Feb;99(9):e19302. doi: 10.1097/MD.0000000000019302.
Clinical trial NCT02661802: Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome
Official title: Acute Effects of 40% Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eisenmenger Complex
Hypertension, Pulmonary
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to evaluate the acute effects of oxygen supplementation during a submaximal exercise test in patients with Eisenmenger's Syndrome.

Detailed description: Patients with Eisenmenger's syndrome were submitted to a submaximal exercise test (six-minute walking test) with and without supplemental oxygen. The distance walked during the two tests were compared to assess the impact of oxygen supplementation on the walking distance.

Eligibility criteria: Inclusion Criteria:

* Abscence of heart failure and/or respiratory infection
* Advanced therapy for pulmonary hypertension

Exclusion Criteria:

* Lung, liver or connective tissue diseases
* Neuromuscular diseases
* Inability to perform a pulmonary function test and/or chronic lung disease
* Inability to walk

Primary outcomes:
measure: Distance walked during the six-minute walk tests
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Laion Gonzaga, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03452202: Using tDCS in Speech-based Stroke Rehabilitation
Official title: Using tDCS in Speech-based Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apraxia of Speech
Keywords: Stroke
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-03-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral treatment with non-invasive brain stimulation. Transcranial direct current stimulation (tDCS), which delivers low-intensity current to the scalp, and is a safe and well-tolerated approach that poses a non-significant risk to participants. tDCS provides low intensity neural stimulation which has been shown to facilitate motor learning in other domains of stroke rehabilitation such as arm motor learning but the potential to enhance speech motor learning has not been explored. This will be examined with a series of single-case experimental designs.


Eligibility criteria: Inclusion Criteria:

* Right-handed
* Monolingual (English)
* Single left-hemisphere CVA
* A minimum of six months post-stroke
* Clinical diagnosis of apraxia of speech
* Normal speech perception
* Passing score on the hearing screening.

Exclusion Criteria:

* Diagnosis of laryngeal voice disorder
* Dysarthria
* History of speech impairment prior to CVA
* Presence of potential tDCS risk factors: damaged skin at site of stimulation;
* Presence of electrically or magnetically activated implant (including pacemaker);
* metal in any part of their body;
* history of medication-resistant epilepsy in the family;
* past history of seizures or unexplained spells of loss of consciousness.

Primary outcomes:
measure: Change in accuracy in recordings from tasks from baseline to post treatment
timeFrame: Baseline, 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Adam Buchwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01786902: Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
Official title: Open, Multi-Center, Controlled, Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-3002(Recombinant Humn Growth Hormone)Treatment in Children With Idiopathic Short Stature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Short Stature
Keywords: growth hormone
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* Chronological Age ≥ 4
* Bone Age \<11 (for girls) and \<13 (for boys)
* Height \<3rd percentile for age
* normal thyroid function

Exclusion Criteria:

* endocrine and/or metabolic disorders
* growth failure caused by other disorders
* previous use of drugs that could interfere with Growth Hormone treatment

Primary outcomes:
measure: Annualized Height Velocity(cm/Year) After 26 Weeks
timeFrame: 26 weeks
Secondary outcomes:
measure: Changes in Height Standard Deviation Score After 26 Weeks
timeFrame: 26 weeks
Other outcomes:
measure: Changes in Anti-growth Hormone Antibody
timeFrame: baseline and 26 weeks
Locations:
Study officials:
affiliation: Asan Medical Center
name: Hanwook Yoo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital
name: Byungkyu Suh, MD
role: STUDY_DIRECTOR
affiliation: Kyungpook National University Hospital
name: Cheolwoo Ko, MD
role: STUDY_DIRECTOR
affiliation: Korea University Anam Hospitial
name: Keehyoung Lee, MD
role: STUDY_DIRECTOR
affiliation: Samsung Medical Center
name: Dongkyu Jin, MD
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Choongho Shin, MD
role: STUDY_DIRECTOR
affiliation: Aju University Hospital
name: Jinsoon Hwang, MD
role: STUDY_DIRECTOR
affiliation: Severance Children's Hospital Yonsei University
name: Hoseong Kim, MD
role: STUDY_DIRECTOR
affiliation: Pusan University Hospital
name: Wooyoung Jeong, MD
role: STUDY_DIRECTOR
affiliation: Chonnam National University Hospital
name: Chanjong Kim, MD
role: STUDY_DIRECTOR
affiliation: Chungbuk National University Hospital
name: Heonsuk Han, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02842502: Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Case of Chronic Leg Ulcers
Official title: Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Patients Carriers of Leg Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leg Ulcer
Keywords: Skin Substitutes
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product) production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7) with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary biopsies are planned to be done in order to be transferred to laboratory. Then, the possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use for skin substitute production in clinical condition is evaluated (primary outcome).


Eligibility criteria: Inclusion Criteria:

* Patient with chronic leg ulcers evolving for more than 6 months
* Patient to receive skin pellet transplant
* Chronic wound area between 10 and 30 cm²

Exclusion Criteria:

* Patient without health insurance,
* Pregnant womens,
* Smoking patient,
* Chronic wound area \>30 cm²

Primary outcomes:
measure: Number of skin substitute reconstructed with cells isolated from patient biopsies
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU de Besançon
Study officials:
affiliation: University Hospital of Besançon
name: Philippe Humbert, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: