louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01763489: ASSIST Tool and Surgical Randomized Controlled Trial Applicability
Official title: Impact of a Graphical Tool on the Reader's Interpretation of Surgical RCT Applicability In the Field of Digestive Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Digestive Cancer
Keywords: randomized controlled trial
applicability
ASSIST tool
surgery
digestive cancer
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: The ASSIST tool is a graphical tool to represent and evaluate the applicability of a surgery trial to improve the translation of research to practice.

Objective: To evaluate the impact of the ASSIST tool on the interpretation of the applicability of randomized controlled trials (RCTs) in the field of digestive cancer surgery.

Design: This study is a randomized controlled trial with two parallel arms. Participants: Surgeons who contribute to the assessment of manuscripts as experts (peer-reviewer) for international scientific journals of surgery (Annals of Surgery, Archives of Surgery, Gastrointestinal Surgery World Journal of International Journal of Surgical Oncology).

Intervention: Surgeons will be randomized into 2 groups. A group that will evaluate a case vignette (synopsis) of a randomized trial in surgery, and the other group that will evaluate the same case vignette with the representation of the external validity of the trial with ASSIST tool.

Outcome measures: Participants will indicate on a numeric scale range from 1 to 10 if they feel able to judge the applicability of the trial for 1) patients, 2) centers, 3) surgeons and 4) intervention.

Sample Size: 28 case vignettes with randomized trials and their ASSIST tool have been developed and evaluated. The inclusion of 130 participants (65 per arm) is required.

Detailed description: The study will be conducted in 2 steps:

In a first step, investigators will develop cases vignettes of published RCTs evaluating surgical interventions in the field of digestive cancer with its representations of external validity according to ASSIST.

In a second step, investigators will invite a panel of peer reviewers to appraise the external validity (applicability) of selected RCTs without and with the graphical tool (ASSIST), on a security web site.

Eligibility criteria: Inclusion Criteria:

* surgeons
* who contribute to the assessment of manuscripts as experts (peer-reviewer) for international scientific journals of surgery (Annals of Surgery, Archives of Surgery, Gastrointestinal Surgery World Journal of International Journal of Surgical Oncology)

Exclusion Criteria:

* No one

Primary outcomes:
measure: feeling able to judge the applicability of the trial
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Boutron Isabelle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00597389: Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims
Official title: The Efficacy of Early Propranolol Administration at Preventing/Reducing PTSD Symptoms in Child Trauma Victims: Pilot.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorders
Keywords: posttraumatic stress disorder
propranolol
inderol
child
trauma
Posttraumatic stress disorders (PTSD)
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: Akron Children's Hospital
name: Ohio Board of Regents
First posted: 2008-01-18
Enrollment: 29
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Twenty-nine pediatric injury patients (ages 10-18) at risk for PTSD were randomly assigned to receive either propranolol or placebo in a double-blind placebo controlled design. Medication was initiated within 12 hours of hospital admission. At 6-weeks, child PTSD symptoms and heart rate (HR) during trauma recall were assessed. We hypothesized that participants who received propranolol would report fewer PTSD symptoms and have lower heart rates than those who received placebo.


Eligibility criteria: Inclusion Criteria:

* Participants consisted of 15 male and 14 female accidental injury patients aged 10-18 recruited from the emergency department of Akron Children's Hospital. - Eligibility criteria included a Glasgow Coma Scale (GCS) score of 14 or greater (to permit informed consent) and an "at-risk" child score on the STEPP (Winston, Kassam-Adams, Garcia-Espana, Ittenbach, \& Cnaan, 2003), a screen for risk of PTSD.

Exclusion Criteria:

* Medication-specific exclusion criteria included hypersensitivity to beta-blockers
* Bradycardia
* Cardiogenic or hypovolemic shock
* Diabetes
* Preexisting heart condition; OR
* Treatment for asthma within the year prior to study entry (per Lacy, Armstrong, Goldman, \& Lance, 2002).
* Children were also excluded if they received epinephrine during emergency care or if they sustained any injuries precluding initiation of the propranolol regimen within 12 hours post-trauma.

Primary outcomes:
measure: PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)
timeFrame: 6-week follow-up
Secondary outcomes:
measure: cardiovascular reactivity during trauma description
timeFrame: at 6-week follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Kent State University
name: Douglas L Delahanty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: The efficacy of early propranolol administration at preventing/reducing PTSD symptoms in child trauma victims: Pilot. Nugent, Nicole Renee; Dissertation Abstracts International: Section B: The Sciences and Engineering, Vol 68(4-B), 2007. pp. 2665.
Clinical trial NCT01144689: Mindfulness Training for Smoking Cessation
Official title: Assessing Mindfulness Training as a Mechanistic Probe for Stress-Induced Brain Activation and Relapse Prevention for Tobacco Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Tobacco Smoking
Nicotine Dependence
Smoking Cessation
Keywords: mindfulness
smoking
stress
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects of mindfulness training (MT) compared to standard Smoking Cessation Therapy (SCT) on smoking cessation and stress provocation in individuals trying to quit smoking.


Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18 and 60
2. Smoking 10 or more cigarettes per day
3. Fewer than 3 months of smoking abstinence in the past year
4. Motivated to stop smoking

Exclusion Criteria:

1. Current use of psychoactive medications that have not been at a stable dose for the past six months, are used as mood stabilizers, or are used as smoking cessation treatments. Individuals who are on psychoactive medications that are stable, not mood stabilizers, and not used for smoking cessations are excluded from fMRI sessions but not smoking cessation treatment.
2. Use of another investigational drug within 30 days
3. Any serious or unstable disease within 6 months
4. Meets criteria for substance dependence within the past year
5. Left handed (will be excluded from fMRI only)

Primary outcomes:
measure: Between group differences in continuous abstinence
timeFrame: during treatment and 6, 12 and 18 weeks after treatment initiation
Secondary outcomes:
measure: Between group differences in perceived stress
timeFrame: 6, 12 and 18 weeks after treatment initiation
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
References:
citation: Brewer JA, Mallik S, Babuscio TA, Nich C, Johnson HE, Deleone CM, Minnix-Cotton CA, Byrne SA, Kober H, Weinstein AJ, Carroll KM, Rounsaville BJ. Mindfulness training for smoking cessation: results from a randomized controlled trial. Drug Alcohol Depend. 2011 Dec 1;119(1-2):72-80. doi: 10.1016/j.drugalcdep.2011.05.027. Epub 2011 Jul 1.
citation: Elwafi HM, Witkiewitz K, Mallik S, Thornhill TA 4th, Brewer JA. Mindfulness training for smoking cessation: moderation of the relationship between craving and cigarette use. Drug Alcohol Depend. 2013 Jun 1;130(1-3):222-9. doi: 10.1016/j.drugalcdep.2012.11.015. Epub 2012 Dec 21.
citation: Kober H, Brewer JA, Height KL, Sinha R. Neural stress reactivity relates to smoking outcomes and differentiates between mindfulness and cognitive-behavioral treatments. Neuroimage. 2017 May 1;151:4-13. doi: 10.1016/j.neuroimage.2016.09.042. Epub 2016 Sep 28.
Clinical trial NCT00518089: A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Conjunctivitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 859
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with bacterial conjunctivitis

Exclusion Criteria:

* Signs and/or symptoms of conjunctivitis for more than 96 hours
* Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis
* Clinical diagnosis of chlamydia in either eye

Primary outcomes:
measure: Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6
timeFrame: 6 Days
Secondary outcomes:
measure: Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
timeFrame: Day 6
measure: Percentage of Patients With Microbiological Cure Up to Day 6
timeFrame: 6 Days
measure: Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6
timeFrame: 6 Days
measure: Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6
timeFrame: 6 Days
Other outcomes:
Locations:
city: Downey
country: United States
state: California
city: Rajajinagar
country: India
state: Bangalore
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Heller W, Cruz M, Bhagat YR, De Leon JM, Felix C, Villanueva L, Hollander DA, Jensen H. Gatifloxacin 0.5% administered twice daily for the treatment of acute bacterial conjunctivitis in patients one year of age or older. J Ocul Pharmacol Ther. 2014 Dec;30(10):815-22. doi: 10.1089/jop.2014.0040.
Clinical trial NCT00199589: Treatment of Spastic Equinovarus Foot After Stroke
Official title: Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Equinovarus
Keywords: Spastic equinovarus
Botox
Ankle foot orthosis
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2005-09-20
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox).

Detailed description: This prospective, multicentric open trial evaluates the efficacy of a combined treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox) into the tibialis anterior and/or posterior and/or the long toe flexor, and/or medial and lateral gastrocnemius, and/or soleus muscles \[300 BTA U per injection (Botox - Allergan), diluted with saline to a concentration of 5U/0,1 mL, with electromyography guided injection\]. The patients are followed for one year after treatment.

Eligibility criteria: Inclusion Criteria:

* Stroke patient with equinovarus foot due to severe lower limb extensor spasticity with impaired foot contact during walking
* Ability to walk for at least 10 meters with or without aid
* Stroke interval \< 12 months
* Age \> 18 years old
* Weight \> 30 kg and \< 100 kg
* Written informed consent

Exclusion Criteria:

* Stroke interval \> 12 months
* Age \< 18 years old
* Pregnancy
* Neuromuscular disease
* Previous treatment with BTA
* Fixed contractures impairing mobility
* Mini-Mental Status Examination \< 25
* Aminosides treatment.

Primary outcomes:
measure: Plantar contact during walking
Secondary outcomes:
measure: Gait velocity
measure: Barthel index
measure: MIF
measure: Autosatisfaction by EVA
measure: Asworth scale
measure: Ankle range of motion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Département de Médecine Physique et de Réadaptation
city: Limoges
country: France
facility: Département de Médecine Physique et de Réadaptation, CHU Limoges
Study officials:
affiliation: University Hospital, Limoges
name: Jean-Yves Salle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04802889: Microarchitecture of Vitreoretinal Contact
Official title: Microarchitecture of Vitreoretinal Contact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitreoretinal Detachment
Vitreo-Retinal Adhesion
Keywords: internal limiting membrane
human vitreous
vitreomacular adhesion
vitreoretinal contact
vitreoretinal interface
hyalocytes
collagen
Lead sponsor: The S.N. Fyodorov Eye Microsurgery State Institution
Sponsor class: OTHER_GOV
First posted: 2021-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Investigation of the vitreoretinal contact microarchitecture in the macular and paramacular zones of the human retina.

Detailed description: Purpose: to study the features of the macular ILM, to study the features of the preretinal structures of the vitreous body of the Central retinal region, morphofunctional features of preretinal hyalocytes, and the mechanism of vitreoretinal adhesion.

Study Protocol: examination of donor human eyes obtained from an eye Bank after sampling material for corneal transplantation.

Research method: scanning electron microscopy (SEM) of the central retina (macular and paramacular zone): ILM, preretinal vitreous.

Scientific hypothesis: vitreoretinal adhesion is provided not by laminin and fibronectin, but by the interweaving of vitreous collagen fibers between the epiretinal vitreous (more firmly fixed to the retinal surface) and the cortical vitreous.

Expected results: determination of ILM thickness in the macular zone, microanatomy of preretinal vitreous strutcures, and possible mechanism of vitreoretinal adhesion, establishing the possibility of intravital synthesis of collagen fibers synthesis in the adult vitreous.

Eligibility criteria: Inclusion Criteria:

* eyes from donors without concomitant multiple organ pathology and ophthalmic pathology

Exclusion Criteria:

* eye injury, age over 45 years, concomitant multiple organ pathology, previous eye diseases

Primary outcomes:
measure: the ILM thickness in the macular zone (foveola)
timeFrame: within 3 days after receiving the cadaver eyes
measure: superficial microstructure of ILM
timeFrame: within 3 days after receiving the cadaver eyes
measure: features of the structural microarchitecture of the preretinal vitreous in the macular zone
timeFrame: within 3 days after receiving the cadaver eyes
measure: morphofunctional features of preretinal hyalocytes.
timeFrame: within 3 days after receiving the cadaver eyes
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"
Study officials:
affiliation: The S.N. Fyodorov Eye Microsurgery State Institution
name: Pavel V Lyskin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05572489: Cervicogenic Headache, Cognitive Dysfunction
Official title: Frequency of Cognitive Dysfunction in Individuals With Cervicogenic Headache
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervicogenic Headache
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 30 patients with cervicogenic headache and 30 healthy volunteers

Brief summary: The goal of this study was to determine the frequency of cognitive dysfunction in patients with cervicogenic headache.

participants will be asked questions to determine their cognitive status at once.

Detailed description: A set of survey-type questions will be asked to the participants. Pain and fatigue levels of the patients were measured by visual pain scale (VAS), mood states by Beck depression scale (BDI) and Pain catastrophizing scale (Pain catastrophizing scale), quality of life by Short Form-36 (SF-36), and cognitive status by Standard Mini. mental test (SMMT) and Montreal cognitive assessment scale (MOCA).

Eligibility criteria: Inclusion Criteria:

Clinical Diagnosis of cervicogenic headache be over 18

Exclusion Criteria:

those under the age of 18 Those with neurological deficits Those with rheumatic diseases such as fibromyalgia, polymyalgia rheumatica, ankylosing spondylitis, rheumatoid arthritis Surgery in the cervical region in the past 6 months Those with widespread pain, significant pain in another anatomical location (eg, gonarthrosis) Those who use drugs or substances (alcohol, drugs, etc.) that may cause cognitive impairment Those with known neurological diseases such as cerebrovascular disease, MS, Parkinson's, dementia Those with major psychiatric illness Those with communication problems Those who have started psychiatric medical treatment in the last three months Those with significant hearing or vision problems Those with a history of uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological, endocrine..)

Primary outcomes:
measure: cognitive status
timeFrame: 01.12.2022
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Beyhekim Research and Training Hospital
state: Selçuklu
Study officials:
References:
citation: Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.
citation: Sjaastad O. Cervicogenic headache: comparison with migraine without aura; Vaga study. Cephalalgia. 2008 Jul;28 Suppl 1:18-20. doi: 10.1111/j.1468-2982.2008.01610.x.
Clinical trial NCT03320889: Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2
Official title: Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Educational Intervention includes Pamphlets plus Review with Expert Educator Group 2: Educational Intervention includes Pamphlets only
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to assess patients' attitudes and knowledge of Hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.

Detailed description: The study will compare the effectiveness of providing HCV education by providing a pamphlet and expert education compared to providing a pamphlet only. The information gained in completing this study will help the medical community improve patient education on the disease and specifically understand how the medical community can best serve pregnant patients with opiate dependence burdened by Hepatitis C.

Eligibility criteria: Inclusion Criteria:

* Study population includes Faculty Medical Center obstetrics and postpartum patients enrolled in the HOPE program who are 18 years old or older.
* The study will include patients with and without a Hepatitis C diagnosis.
* Patients will be recruited at their routine office visits and/or during any admissions to the hospital.

Exclusion Criteria:

* Patients who do not speak and understand English.

Primary outcomes:
measure: Number of Questions Scored Correct on the Hepatitis C Knowledge Survey
timeFrame: 2-8 weeks after study intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Michael Marcotte, MD
role: PRINCIPAL_INVESTIGATOR
References: