louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01978678: Does Asthma Phenotype Have Impact on Disease Control
Official title: Does Asthma Phenotype Have Impact on Disease Control - Can Detection of Inflammation and Hyper Responsiveness Ensure Stable Disease Faster
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly referred asthma patients

Brief summary: The application of biomarkers that are more closely associated with eosinophillic airway inflammation, such as measurements of FeNO level, cell count in induced sputum or bronchial reactivity could improve asthma control by better directing treatment. A systematic review and meta-analysis is to be conducted to assess the efficacy of tailoring asthma intervention on clinical symptoms compared with exhaled nitric oxide or induced sputum count.

Detailed description: AHR used as outcome

Eligibility criteria: Inclusion Criteria:

* positiv mannitol
* asthma diagnose

Exclusion Criteria:

* other lung disease

Primary outcomes:
measure: Control of asthma based on an algorithm
timeFrame: 2 years
Secondary outcomes:
measure: The use of NO and sputum cell count as a marker in asthma management
timeFrame: 2 years
Other outcomes:
measure: the use of ACQ and miniAQLQ
timeFrame: 2 years
Locations:
city: Copenhagen
country: Denmark
facility: Department of Respiratory Medicine, L, Bispebjerg Hospital,
state: NV
city: Copenhagen
country: Denmark
facility: Respiratory research unit, Bispebjerg University Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Vibeke Backer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01148407: Platelet Modulation: A Study of Angiogenic and Coagulation Proteins in Patients With Cancer
Official title: Platelet Modulation in the Control of Angiogenesis: A Study of Angiogenic and Coagulation Proteins in Patients With Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: breast cancer
platelets
metastatic cancer
malignancy
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a malignancy diagnosis.

Brief summary: Blood samples on persons with cancer will be sampled for angiogenic, metastatic and coagulation proteins.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of malignancy

Exclusion Criteria:

* Patients taking aspirin, NSAIDs, warfarin or platelet inhibitor therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont/Fletcher Allen Health Care
state: Vermont
Study officials:
affiliation: University of Vermont
name: Chris E Holmes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03318107: Ultrasound and Photoacoustic Imaging for Cervical Cancer
Official title: Pilot Study of Ultrasound and Photoacoustic Imaging for Assessing Treatment Response of Cervical Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Cancer
Cancer of the Cervix
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 2
Sex: FEMALE
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 investigators have developed co-registered transvaginal photoacoustic and ultrasound (US) imaging techniques that allow them to visualize ovarian tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development or residual tumors after systemic treatment that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes using a non-invasive imaging modality will greatly enhance the care for patients. The investigators plan to explore these techniques in monitoring cervical cancer treatment response and conduct pilot feasibility studies.


Eligibility criteria: * Diagnosis of cervical cancer of any stage that will be treated with radiation therapy and concurrent chemotherapy.
* At least 18 years of age.
* Not pregnant and/or breastfeeding.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Primary outcomes:
measure: Number of participants who complete the imaging protocol
timeFrame: Approximately 18 weeks
Secondary outcomes:
measure: Reduction rate of tumor angiogenesis
timeFrame: 3 months after completion of standard of care treatment (approximately 18 weeks)
measure: Charge pattern of blood oxygen saturation
timeFrame: 3 months after completion of standard of care treatment (approximately 18 weeks)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Perry W Grigsby, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03584607: Insulin- and Glucose Metabolism in Pulmonary Arterial Hypertension
Official title: Insulin- and Glucose Metabolism in Pulmonary Arterial Hypertension - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls, or patients with idiopathic or hereditary pulmonary hypertension

Brief summary: Insulin resistance is a key mechanism in metabolic disorders, which has also been implicated in the development of pulmonary hypertension. In this pilot study, the investigators´ goal is to directly determine insulin sensitivity in idiopathic pulmonary arterial hypertension patients and to compare the results with data from healthy controls.


Eligibility criteria: Inclusion Criteria:

* signed informed consent form
* patients with idiopathic or hereditary pulmonary hypertension / healthy controls

Exclusion Criteria:

* premenopausal women
* other relevant lung disease
* relevant left heart disease
* untreated systemic hypertension
* Diabetes mellitus
* pulmonary hypertension other than idiopathic or hereditary form

Primary outcomes:
measure: Insulin resistance
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz, Division of Pulmonology
state: Steiermark
Study officials:
affiliation: Medical University of Graz
name: Bence M. Nagy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagy BM, Kovacs G, Tornyos A, Svehlikova E, Foris V, Nagaraj C, Kwapiszewska G, Pieber TR, Olschewski A, Olschewski H. No indication of insulin resistance in idiopathic pulmonary arterial hypertension with preserved physical activity. Eur Respir J. 2020 Jun 11;55(6):1901228. doi: 10.1183/13993003.01228-2019. Print 2020 Jun. No abstract available.
Clinical trial NCT03704207: Utility of PCD Diagnostics to Improve Clinical Care
Official title: Utility of PCD Diagnostics to Improve Clinical Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Ciliary Dyskinesia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing.

Detailed description: This study is a prospective data collection of individuals referred to the investigators clinical center for considerations of PCD. Participants sign informed consent to have clinical information entered into a secure electronic database. As part of this study, participants may have nasal nitric oxide (nNO) testing performed. nNO testing is a research procedure, but it is a test with growing utility for making a diagnosis of PCD when performed in the right clinical setting.

Eligibility criteria: Inclusion Criteria:

* Referred to center for PCD diagnosis considerations
* Ability to perform study procedures
* Age greater than 2 years of age

Exclusion Criteria:

* Age less than 2 years of age Inability to perform informed consent

Primary outcomes:
measure: frequency of nNO tests performed
timeFrame: 3 years
measure: Frequency of genetic tests performed
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Children's hospital
state: Tennessee
Study officials:
References:
Clinical trial NCT06915207: Adult Depression and Integrative Medical Care
Official title: Integrative Medical Care For Adult Depression: A One Year Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: adults
Depression
Integrative medical care
quasi-experimental design
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal over 1 year
Primary purpose: TREATMENT

Brief summary: The goal of this quasi-experimental study is to learn if integrative medical care works to treat depression in adults and compare it to usual medical care. The main question it aims to answer is to find out whether integrative medical care is equal or better to usual medical care in treating depressed adults over one year.

Participants attended five data collection visits which occurred at baseline, 3, 6, 9 and 12 months. At each visit, they completed questionnaires and had a small blood sample drawn. They were also asked to keep a diary of their symptoms and what they did between visits. They brought a calendar summary with a saliva sample at visits 2 to 5.


Eligibility criteria: Inclusion Criteria:

* experiencing depressive symptoms as defined by a Centre for Epidemiologic Studies-Depression (CES-D) scale score of 16 or higher as categorized by Lewinsohn et al.
* willing to commit to five study visits over one year.

Exclusion Criteria:

* substance abuse
* pregnancy
* non-depression neurological problems.

Primary outcomes:
measure: Change in depression
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Anne Leis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saskatchewan
name: Shirley Maltman, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01308307: Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?
Official title: Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amblyopia
Keywords: Non-cycloplegic photorefraction
cycloplegic refraction,
Amblyopia
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-03-04
Enrollment: 185
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Purpose: : This study was performed to compare the accuracy of non-cycloplegic photorefraction with cycloplegic refraction in detection of refractive amblyopia risk factors and determine some corresponding beneficial cut points.

Method: In this diagnostic accuracy study, right eyes of 185 children (1 to 14 years) underwent first non-cycloplegic photorefraction (with PlusOptix SO4 photoscreener) and then cycloplegic refraction from October 2009 to August 2010. Based on the cycloplegic refraction results, hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines. The difference in detection of refractive amblyopia risk factors between the two methods was the main outcome measure.


Eligibility criteria: Inclusion Criteria:

* \> 1 year old /with consent

Exclusion Criteria:

* mental retardation
* impaired fixation
* strabismus
* ptosis and any other organic ophthalmic disorder interfering with refraction

Primary outcomes:
measure: refraction
timeFrame: 10 months
Secondary outcomes:
measure: hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines.
timeFrame: 10 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinejad medical center
Study officials:
References:
Clinical trial NCT00182507: Olanzapine in the Treatment of Hair Pulling (Trichotillomania)
Official title: A 12-Week, Double-Blind Trial of Olanzapine and Placebo in the Treatment of Trichotillomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trichotillomania
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2005-09-16
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trichotillomania (TTM) or hair-pulling has been considered as part of the obsessive compulsive disorder (OCD) spectrum, although treatment with OCD medications has largely been unsuccessful. Tics/Tourrettes' Syndrome (TS) is a disorder, which appears to be related to TTM, but is treated with a different class of medications than used in OCD, namely antipsychotics such as olanzapine. This is a study of the safety and efficacy of olanzapine in the treatment of hair pulling.


Eligibility criteria: Inclusion Criteria:

* primary DSM-IV trichotillomania; CGI-Severity ≥ 4

Exclusion Criteria:

* Any other Axis I primary diagnosis; CGI-S \< 4; current comorbid: OCD, MDD, alcohol or substance abuse; lifetime hx of: schizophrenia, bipolar affective disorder or dementia; current pregnancy/lactation; current suicidality or homicidality; major medical problems or clinically unstable medical disease; hx of: seizures, stroke or head trauma; prior use of neuroleptics

Primary outcomes:
measure: Clinical Global Impression (CGI)-Improvement Scale ≤ 2
Secondary outcomes:
measure: CGI-Severity Scale, Mean change from baseline in: Yale-Brown Obsessive Compulsive Scale for TTM, the Massachusetts General Hospital Hair Pulling Scale
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, McMaster University Medical Centre
state: Ontario
Study officials:
affiliation: Hamilton Health Science, McMaster Univeristy Medical Centre
name: Michael A Van Ameringen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.
citation: Van Ameringen M, Mancini C, Patterson B, Bennett M, Oakman J. A randomized, double-blind, placebo-controlled trial of olanzapine in the treatment of trichotillomania. J Clin Psychiatry. 2010 Oct;71(10):1336-43. doi: 10.4088/JCP.09m05114gre. Epub 2010 Apr 20.
Clinical trial NCT00100607: Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
Official title: Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: osteoporosis/osteopenia, BMD, postmenopausal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-01-04
Enrollment: 676
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with osteoporosis.


Eligibility criteria: Inclusion Criteria:

* BMD T Score between -2 to -3.5
* 50-75 years old

Exclusion Criteria:

* Urolithiasis
* Bisphosphonates

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Lumbar spine BMD and total hip BMD after 1 year treatment
measure: Safety and tolerability of one year treatment with different doses
Secondary outcomes:
measure: Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body
measure: Effect of the different doses on markers for bone formation and bone resorption
measure: Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment
measure: Histological information on bone biopsy after 12 months of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04739007: Pulmonary Physiologic Assessment of Patients on Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)
Official title: Pulmonary Physiologic Assessment of Patients on Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiac Arrest
Pulmonary Injury
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients without underlying pulmonary disease on VA ECMO post-cardiac arrest

Brief summary: There is limited data on the respiratory system mechanics and ideal mode of ventilation for patients on veno-arterial extra-corporeal membrane oxygenation (VA ECMO) post cardiac arrest. In this observational study, the investigators will review and/or obtain laboratory, hemodynamic, respiratory system mechanical, and clinical data from patients on VA ECMO. The specific aims of this study are as follows:

Aim 1: To characterize the lung ventilation strategy employed in patients on VA ECMO and its success.

Aim 2: To characterize respiratory system mechanics while on ECMO using esophageal manometry and Electrical Impedance Tomography (EIT).

Aim 3: To characterize right heart function and pulmonary vascular hemodynamics on the employed ventilation strategy.

The overarching hypothesis is that fine-tuned individualized ventilation might be superior to an algorithm that does not account for cardiac and pulmonary functions. Therefore, the aims of this study are to identify areas in which the ventilation strategy may theoretically be suboptimal, which will guide future interventional studies investigating alternatives methods of ventilation which may reduce time on the ventilator after cardiac arrest, time in the intensive care unit, and need for veno-venous ECMO.


Eligibility criteria: Inclusion Criteria:

* On VA ECMO after cardiac arrest
* Between 18 and 85 years of age
* Has an orogastric or nasogastric tube with esophageal balloon capabilities in place

Exclusion Criteria:

* Known pre-existing significant pulmonary pathology
* Pacemaker or implanted cardiac defibrillator

Primary outcomes:
measure: Percent of total distribution of ventilation by region, on given ventilator settings
timeFrame: Within 24-48 hours of ECMO cannulation
Secondary outcomes:
measure: Time on VA-ECMO
timeFrame: 14 days, 90 days
measure: Need to transition to VV-ECMO
timeFrame: 14 days, 90 days
measure: Time on mechanical ventilation
timeFrame: 14 days, 90 days
measure: Time in ICU
timeFrame: 14 days, 90 days
measure: 90-day mortality
timeFrame: 90 days
measure: Incidence of ventilator-associated pneumonia
timeFrame: 14 days, 90 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT02729688: Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer
Official title: Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency
Keywords: Venous insufficiency
Compression
Bandaging
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective of this study are to compare the interface pressure by applying ordinary elastic bandage (OEB) and CPG-EB. In addition, investigators compared the percentage of patients who could apply the optimal pressure with OEB and CPG-EB.

Detailed description: For treatment of venous ulcer, it was shown that compression bandaging of 35-45 mmHg sub-bandage pressure at the ankle was shown in several studies to be safe and effective.The efficacy of compression bandage considerably depends on the applied pressure and it is therefore largely dependent on the individual applying bandages. The lower pressure leads to treatment failure while the higher pressure leads to skin complication.

The use of objective devices to proof that the bandage is sufficiently applied is not available for every patients. To help the patients to apply the bandage with optimal pressure, investigators developed the customized pressure guide elastic bandage (CPG-EB) by using sub-bandage pressure guidance.

Objective of this study are to compare the interface pressure by applying ordinary elastic bandage (OEB) and CPG-EB. In addition,investigators compared the percentage of inexperienced staffs who could apply the optimal pressure with OEB and CPG-EB.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic venous insufficiency CEAP (clinical, etiologic, anatomic, and pathophysiologic) C4,C5 and C6

Exclusion Criteria:

* Patients who can not perform bandaging by themselves

Primary outcomes:
measure: Sub-bandage pressure
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Vascular Surgery, Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Nuttawut Sermsathanasawadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sermsathanasawadi N, Tarapongpun T, Pianchareonsin R, Puangpunngam N, Wongwanit C, Chinsakchai K, Mutirangura P, Ruangsetakit C. Customizing elastic pressure bandages for reuse to a predetermined, sub-bandage pressure: A randomized controlled trial. Phlebology. 2018 Oct;33(9):627-635. doi: 10.1177/0268355517746434. Epub 2017 Dec 25.