louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03496350: Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression
Official title: Culturally Adapted Transdiagnostic Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2018-04-12
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants get randomly assigned to either treatment or wait-list control.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of a culturally adapted internet-administrated cognitive behaviour therapy (ICBT) in Arabic for anxiety and depression

Detailed description: The study will compare the effect of the intervention against a wait-list control. The intervention tested is based on cognitive behavior therapy delivered over the internet via a secure treatment platform. Participants in the study are recruited from the general public via social media. The intervention is in Arabic.

Eligibility criteria: Inclusion Criteria:

* Be above 18 years of age
* Have symptoms of anxiety and/or depression
* Be able to read and write in Arabic
* Have access to computer or smartphone

Exclusion Criteria:

* Suicidal ideation
* Alcohol addiction
* Other major primary psychiatric disorder
* Ongoing psychological treatment
* Recent (during last 4 weeks) change in psychiatric medication

Primary outcomes:
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment
measure: Change in Generalised Anxiety Disorder-7-item scale, (GAD-7)
timeFrame: pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment
Secondary outcomes:
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: pre-treatment, week 8
measure: Insomnia Severity Index (ISI)
timeFrame: pre-treatment, week 8
measure: Impact of Events Scale - Revised (IES-R)
timeFrame: pre-treatment, week 8
measure: Perceived Stress Scale (PSS)
timeFrame: pre-treatment, week 8
measure: "Brunnsviken Brief Quality of Life Scale" (BBQ)
timeFrame: pre-treatment, week 8
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00060450: Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation
Official title: Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ischemia-Reperfusion Injury
Keywords: Ischemia-reperfusion lung injury
IRLI
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2003-05-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of inhaled nitric oxide on both short-term physiology as well as on the development of ischemia-reperfusion lung injury (IRLI) in the immediate post transplant period. The specific hypothesis is that inhaled NO post lung transplantation will improve gas exchange/hemodynamic and thus reduce the development of post transplant IRLI.

Detailed description: The objective is to determine the role of inhaled NO in the prevention/treatment of IRLI in lung transplant patients. The plan is to accomplish this objective in 2 phases:

Phase 1 - patients immediately post transplant will have a variety of physiologic measurements performed while breathing 0, 10, and 20 ppm inhaled NO. For the next 24 hours they will be kept on a mixture providing the best oxygen delivery and pulmonary artery pressure. Our specific aims in this phase are to characterize physiologic responses to inhaled NO and determine the incidence of IRLI in these patients over 24 hours.

Phase 2 - patients immediately post transplant will be randomized to either INO or placebo gas and followed for 24 hours. Our specific aim in this phase is to compare the rate of development of IRLI in the two groups.

Eligibility criteria: Inclusion criteria:

* Patients undergoing lung transplantation

Exclusion criteria:

* Participation in other experimental protocols

Primary outcomes:
measure: arterial and mixed venous blood gases
timeFrame: first 4 hours post transplant
measure: pulmonary vascular pressures
timeFrame: first 4 hours post transplant
Secondary outcomes:
measure: cardiac output
timeFrame: first 4 hours post transplant
measure: systemic hemodynamics
timeFrame: first 4 hours post transplant
measure: NO2 and NO concentrations
timeFrame: duration of treatment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Neil MacIntyre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04753450: Correlation of Muscle Ultrasound Measures (2D and 3D) With Biphotonic X-ray Absorptiometry in Oldest Old Patients.
Official title: Correlation of Muscle Ultrasound Measures (2D and 3D) With Biphotonic X-ray Absorptiometry in Oldest Old Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assessment, Self
Muscle Atrophy
Ultrasound Therapy; Complications
Aging
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 62
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older patients who agrees to participate to the study will undergo 3D ultrasound muscle mass measurement, 2D panoramic mode muscle mass measurement and biphotonic X-ray absorptiometry assessment, the same day. Correlation analysis will be done with the different measurement.

Brief summary: The sarcopenia diagnosis is based on the muscle mass and on impaired physical performance. The emerging field of ultrasound assessment of muscle mass in older patients is based on 2d parameters with prediction equations for muscle mass. For the moment, validation of prediction equations in older adults with varying function and health is lacking. The study aims to evaluate correlation of muscle mass between 3D muscle mass measurement and DXA, in order to dispense with the prediction equation.

Detailed description: Older patients who agree to participate to the study will undergo 3D ultrasound muscle mass measurement, 2D panoramic mode muscle mass measurement and biphotonic X-ray absorptiometry assessment. Correlation analysis will be done with the different measurement.

Eligibility criteria: Inclusion Criteria:

* Patients over 75 years old
* Osteoporosis diagnosis confirmed by Dual-energy X-ray Absorptiometry

Exclusion Criteria:

* Neurocognitive disorders preventing the expression of informed consent
* Patients who cannot undergo an examination in a static position
* Lack of a measurement site (muscle resection or amputation)
* Any state of dehydration or water inflation
* Patient with legal protection measure

Primary outcomes:
measure: 3D Correlation between muscle volume measured by 3D ultrasound and standard method : DXA results
timeFrame: 1 week
Secondary outcomes:
measure: 2D correlation between muscle volume measured by 2D ultrasound and standard method : DXA results
timeFrame: 1 week
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References:
Clinical trial NCT00484250: Study of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Lichen Planus
Keywords: Oral Lichen Planus
Metronidazole
Doxycycline
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-06-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oral lichen planus (OLP) is a chronic inflammatory disorder which causes local irritation,discomfort and subsequent poor dentition and discomfort in eating . Various treatments have been suggested for OLP but their results are unsatisfactory .Despite the fact that steroids have been the main therapeutic choice for many years,some researches have been done regarding the efficacy of other medication such as metronidazole and doxycycline.The purpose of this study is to determine whether metronidazole and doxycycline are effective in the treatment of oral lichen planus and to compare their efficacy with each other.


Eligibility criteria: Inclusion Criteria:

* a biopsy-proven untreated OLP of every type with no symptom.

Exclusion Criteria:

* pregnancy, presence of dysplasia in lesions,unilateral lesion suspected lichenoid reaction,history of drinking alcohol in at least 1 month prior to the study, smoking, systemic disease, use of systemic medications and hypersensitivity to the metronidazole and doxycycline.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University Of Medical Sciences(Dentistry School)
state: Khorasan
Study officials:
affiliation: Tehran University of Medical Sciences
name: Arash Mansourian, DDS,MS
role: STUDY_CHAIR
affiliation: Mashhad University of Medical Sciences
name: Majid Sanatkhani, DDS,MS
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Fatemeh Momen Heravi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00200850: Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy
Official title: Sublingual Immunotherapy in Dust Mite Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Breathing
Allergy
Mites, House Dust
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2005-09-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate sublingual immunotherapy (SLIT), a treatment involving antigens placement under the tongue to help asthma sufferers build a tolerance to the allergy-causing substances. Specifically, this study will determine the effectiveness of SLIT at two different dosing regimens for patients with intermittent mild asthma caused by dust mites.

Detailed description: Asthma is a serious lung condition that is the leading cause of long-term illness in children. Many common household substances can trigger or worsen an asthma attack. It is important for people to reduce household allergens and learn effective treatments for specific types of asthma. Inhaled short-acting beta agonist such as albuterol is the standard treatment for mild, intermittent asthma. However, recent studies have shown that adding allergen-specific immunotherapy to your current asthma therapy can help to control asthma symptoms. This study will determine the safety and effectiveness of SLIT in two different dosing regimens in treating patients with house dust mite-induced allergic rhinitis/mild intermittent asthma.

Participants will be randomly assigned to receive low dose SLIT, high dose SLIT, or placebo for at least 12 months. House dsut mite-induced allergy skin tests will be performed at study entry, at selected timepoints throughout the study, and at the end of the study. The tests will determine whether SLIT creates an immune tolerance state as well as whether SLIT acts via local or systemic immunological systems.

Eligibility criteria: Inclusion Criteria:

* House dust mite-induced allergic rhinitis/mild intermittent asthma

Exclusion Criteria:

* Use of previous allergy immunotherapy for house dust mite asthma
* Pregnancy or breastfeeding

Primary outcomes:
measure: Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment
timeFrame: baseline and after 12-18 months treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Medical School
name: Robert K. Bush, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bush RK, Swenson C, Fahlberg B, Evans MD, Esch R, Morris M, Busse WW. House dust mite sublingual immunotherapy: results of a US trial. J Allergy Clin Immunol. 2011 Apr;127(4):974-81.e1-7. doi: 10.1016/j.jaci.2010.11.045. Epub 2011 Feb 18.
Clinical trial NCT05760508: Novel Markers of Disease Progression in Interstitial Lung Disease
Official title: Novel Markers of Disease Progression in Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Disease
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with a diagnosis of ILD

Brief summary: Study design: A prospective cohort study with a longitudinal design, with several parameters measured serially at baseline and at pre-specified time points during three to five years of clinical observation.

Primary objective: To validate quantitative analysis of lung sounds as a marker of disease progression in a cohort of patients with Interstitial Lung Disease (ILD) via correlation with the extent of fibrosis on HRCT, measured both via visual scoring and quantitative CT assessment, and other validated parameters of disease progression such as FVC, tolerance to exercise and patient-related outcomes (symptoms and quality of life).

Secondary objectives: To determine the prognostic value of quantitative analysis of lung sounds and a series of novel putative biological markers, obtained from peripheral blood and bronchoalveolar lavage, toward poor outcomes (death, categorical decline of % predicted FVC \>10%, acute exacerbation or respiratory-related hospitalisations) as compared to more conventional clinical, physiology and radiologic measurements.


Eligibility criteria: Inclusion Criteria:

* diagnosis of ILD, made according to international guidelines where available
* age between 40 and 90 years

Exclusion Criteria:

* significant comorbidities or physical impairment that could affect participation

Primary outcomes:
measure: Disease progression
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Agostino Gemelli IRCCS
state: Roma
Study officials:
References:
Clinical trial NCT04756908: Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery
Official title: Evaluation of the Visual Performance and Safety of the Investigational Opira AIOL, A Commercial Multifocal IOL, and a Commercial Monofocal IOL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Lead sponsor: FSV6, Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical trial comparing an investigative accommodative IOL and two commercial IOLs in patients with cataracts undergoing primary cataract surgery.

Detailed description: This is a prospective, multicenter clinical study comparing the safety and performance of the Opira accommodative IOL, a commercial monofocal IOL, and a commercial multifocal IOL. Eligible patients with bilateral cataracts will undergo cataract surgery implanting one of three study lenses, and will be followed postoperatively for 24 months

Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 50-75 with bilateral cataracts, good potential vision, and clear intraocular media other than lens opacity

Exclusion Criteria:

* Comorbidities affecting visual acuity, IOP \> 22mmHg, congential cataract

Primary outcomes:
measure: Visual Acuity
timeFrame: 6 Months
measure: Adverse event rates
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: Clinica 2020
city: Tijuana
country: Mexico
facility: Codet Vision Institute
Study officials:
References:
Clinical trial NCT02459808: Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome
Official title: Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Guillain-Barre Syndrome
Constipation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Aarhus University Hospital, admitted with Guillain-Barré syndrome.

Brief summary: Constipation is a common condition among patients with Guillain-Barré Syndrome. It is believed, that the constipation is caused by autonomic neuropathy. However, the severity of the constipation, and its relation to autonomic function have not previously been studied.


Eligibility criteria: Inclusion Criteria:

* Guillain-Barré Syndrome
* Ability to swallow the capsules used to assess GITT
* Ability to give meaningful informed consent to participate in the study

Exclusion Criteria:

* Major abdominal disorders
* Severe acute comorbidity
* Known cancer
* Pregnancy
* Other known neurological disorder
* Use of laxatives one week before inclusion. (Patients will be excluded if medication with laxatives is started during the one week GITT measurement)

Primary outcomes:
measure: Gastrointestinal transit time (GITT) [in days]
timeFrame: The measurement takes one week to perform. The investigators aim to start the measurement within one week after diagnosis.
Secondary outcomes:
measure: Association between heart rate variability (HRV) and GITT
timeFrame: The first HRV measurement is performed within one week after diagnosis. The second is performed 7 days after the first.
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Henning Andersen, Professor, Dr. med. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00823108: Rapid Administration of Insulin in Sepsis
Official title: Rapid Administration of Insulin in Sepsis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Septic Shock
Keywords: GIK, septic shock, sepsis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2009-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a glucose-insulin-potassium (GIK) solution can be safely administered to patients with septic shock. GIK has been used in thousands of critically ill patients in research studies with very few safety concerns. However, there is a lack of data in regards to patients with septic shock. There are many reasons to believe that GIK would be beneficial in sepsis, including improving heart function and decreasing inflammation. This study will administer intravenous GIK for 12 hours continuously and monitor 10 subjects for 24 hours. A control arm will be used and 10 patients will receive the same monitoring but will not receive GIK.


Eligibility criteria: Inclusion Criteria:

1. Suspected or confirmed infection;
2. Any two of four criteria of systemic inflammatory response:

   * Temperature \> 100.4° or \< 96.8° F
   * Heart rate \> 90 beats/minute
   * Respiratory rate \> 20 breaths/min. or PaCO2 \< 32 mm Hg
   * WBC \>12,000 or \< 4000 cells/µL or \> 10% bands
3. Initiation of quantitative resuscitation protocol in the ED;
4. Requirement of high dose vasopressors (defined as a cumulative vasopressor index = 4) to treat shock

Exclusion Criteria:

1. Age \<18 years;
2. Pregnancy;
3. Any primary diagnosis other than sepsis;
4. Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable;
5. Known hyperkalemia (serum potassium \>5.5);
6. Dialysis-dependent renal failure;
7. Anticipated requirement for immediate surgery (within 24 hours);
8. Active participation in another interventional study;
9. Transferred from another hospital setting with sepsis therapy initiated;
10. Inability to obtain informed consent;
11. Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment;
12. Active malignancy currently under treatment (chemo- or radiation therapy);
13. Known systemic allergy to insulin;
14. History of periodic paralysis associated with carbohydrate loading;
15. Receiving continuous intravenous inotropic support (including dobutamine, milrinone, amrinone, and levosimendan).

Primary outcomes:
measure: Absolute safety endpoint (explicit definitions)
timeFrame: During infusion
measure: Change in SOFA score, microcirculatory flow
timeFrame: During infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center
name: Alan E Jones, MD
role: STUDY_DIRECTOR
References: