louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06536569: Comparison of Efficacy Between ILM Forceps
Official title: A Comparison of the Efficacy of 25g Grieshaber Sharkskin ILM Forceps With Reflex Handle vs Standard 25g Grieshaber ILM Forceps for Internal Limiting Membrane Peeling
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Macular Holes
Epiretinal Membrane
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2024-08-05
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a Single center, prospective, observational, multi surgeon randomized controlled trial. Subjects will be assessed pre-operatively, operatively and at 1 month postoperatively. Clinical evaluations will include measurement of visual acuity and optical coherence tomography (OCT).


Eligibility criteria: Inclusion Criteria:

• 19y and older patients with symptomatic ERM (grade 2-3) or Macular hole (non flap-requiring) for elective ILM peeling surgery.

Exclusion Criteria:

* Co-morbid diabetic retinopathy of any grade.
* Neovascular AMD.
* Previous vitrectomy.
* Previous retinal detachment treated with scleral buckle or pneumatic retinopexy.
* Uncontrolled glaucoma or previous glaucoma surgery.
* Combined phacovitrectomy.
* Macula holes with severity requiring flap.

Primary outcomes:
measure: Number of attempts to initiate peeling
timeFrame: Surgery (Operative Visit)
Secondary outcomes:
measure: Number of handle-ReSite/widefield viewing system lens touches
timeFrame: Surgery (Operative Visit)
measure: Duration of Peel
timeFrame: Surgery (Operative Visit)
measure: Number of deep retinal grasps
timeFrame: Surgery (Operative Visit)
Other outcomes:
measure: Corrected Distance Visual Acuity
timeFrame: 1 Month Postoperatively
Locations:
city: Vancouver
country: Canada
facility: Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology
state: British Columbia
Study officials:
affiliation: UBC
name: Bryon McKay, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01564069: Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy
Official title: Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Chronic pain
Intrathecal pain management
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males or females greater than 18 years of age History of chronic pain greater than 6 months Patient in the BWH Pain Center for greater than 6 months

Brief summary: Our hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement treatment efficacy when compared to patients with chronic pain managed with oral or systemic opioid therapies. Our secondary hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement in treatment efficacy when compared to patients with chronic pain who are managed with non-opioid therapies.


Eligibility criteria: Inclusion Criteria:

* Males or females greater than 18 years of age with legal decision making ability.
* Subjects receiving care at the Brigham and Women's Hospital Pain Management Center.
* Subjects must have a history of chronic pain \> 6 months and must have been a patient in the BWH Pain Center \> 6 months.

Exclusion Criteria:

* Pain due to metastatic cancer or to cancer that is locally invasive
* Patients with a primary diagnosis of spasticity, receiving intrathecal baclofen
* Evidence of psychosis or hospitalization for psychiatric illness during study
* Pregnancy at any time during the study
* Altered mental status that would make subject unable to complete outcome questionnaires
* Significant chronic medical illness, such that requires frequent hospitalization or health care utilization (ie: renal failure requiring dialysis, heart failure or cardiac disease requiring surgery or intensive care admission, pulmonary disease requiring intubation or hospitalization, pancreatitis requiring hospitalization, vascular disease requiring surgery or hospitalization, etc.)

Primary outcomes:
measure: Treatment Efficacy of Intrathecal Infusions
timeFrame: March 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Srdjan S Nedeljkovic, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04351269: Retrospective Experience Of CIED Implantation
Official title: Retrospective Experience of CIED Implantation With Piedmont Athens Regional Electrophysiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Heart Failure
Coronary Artery Disease
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-17
Enrollment: 597
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients who underwent a CIED implantation utilizing a CanGaroo Envelope hydrated in saline, a CanGaroo Envelope hydrated in an antibiotic solution, a TYRX Envelope, or no envelope.

Brief summary: The objective of this study is to retrospectively gather information on patients who underwent a CIED procedure with either a CanGaroo Envelope, TYRX Envelope, or no envelope.

Detailed description: A single center will retrospectively review up to 700 subjects who underwent implantation of a CIED with a CanGaroo Envelope, TYRX Envelope, or no envelope. All sets of subjects enrolled will also be examined for any follow-up visits and/or adverse events that occurred up to 12 months post-surgery.

Eligibility criteria: Inclusion Criteria:

* Any patient that had a CIED implanted with either a CanGaroo Envelope, a TYRX Envelope, or no envelope on or after March 27, 2017

Exclusion Criteria:

* Any patient that had a CIED implanted with any other type of envelope
* Any patient that had a CIED implanted prior to March 27, 2017

Primary outcomes:
measure: Number of Participants With Major Infection Post Procedure
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Number of Participants With Pocket Related Issues Prompting an Office Visit
timeFrame: 12 months post procedure
Other outcomes:
Locations:
city: Athens
country: United States
facility: Piedmont Athens Electrophysiology
state: Georgia
Study officials:
affiliation: Aziyo Biologicgs, Inc.
name: Jerome Riebman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02966769: N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation
Official title: Multicentric Retrospective Observation Study: Neoadjuvant Treatment and Surgery Versus Definitive Chemoradiation in the Non-Small Cell Lung Cancer (NSCLC) IIIA-N2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small-Cell Lung Carcinoma
Surgery
Stage IIIA-N2
Chemoradiation
Survival
Lead sponsor: Grupo de Investigación Clínica en Oncología Radioterapia
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 294
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stage IIIA-N2 NSCLC potentially resectable at diagnosis.

Brief summary: The objective of this multicenter retrospective study is to compare overall survival in patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus definitive chemoradiation.

Secondary objectives are to analyze disease-free survival, median survival, locoregional and distant relapses as well as mortality and toxicity related to treatment.

Detailed description: Based on data published by the Intergroup 0139 trial, induction therapy followed by surgery in patients with stage IIIA-N2 NSCLC can increase overall survival compared to exclusive radical chemoradiation treatment.

The major handicap of all studies addressing the role of surgery in IIIA-N2 NSCLC is the difficulty of recruiting patients. Therefore, multicenter studies are necessary to confirm the hypothesis generated by the INT 0139.

Eligibility criteria: Inclusion Criteria:

* Stage IIIA (N2) disease
* Potentially resectable disease
* Stage Lung Cancer with CT scan or PET-CT.
* N2 involvement: it is not necessary pathological proof.
* No progression after induction treatment.

Exclusion Criteria:

* T4 or N3 stage.
* Bulky disease or not resectable.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 5 years
measure: Patterns of Relapse
timeFrame: 5 years
measure: Mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Quiron Madrid
Study officials:
affiliation: Grupo de Investigación Clínica en Oncología Radioterapia
name: Felipe Couñago, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Grupo de Investigación Clínica en Oncología Radioterapia
name: Sara Montemuiño, MDPhd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00908869: Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b (" Metronomic Chemotherapy ") for Antiangiogenic and Antivascular Effect. Trial With Pharmacodynamic Study in Adult Advanced Neoplasm
Official title: Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b for Antiangiogenic/Antivascular Effect in Adult Advanced Neoplasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Neoplasm
Keywords: advanced neoplasm
adult advanced neoplasm
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2009-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose:

This phase I trial estimates the antiangiogenic and antivascular effect of 4 different levels of continuous low doses of the combination of Vinorelbine, Cyclophosphamide and Interferon alpha 2b (" metronomic chemotherapy ")in adult advanced neoplasm.

This study is non randomized, monocentric, and with a pharmacodynamic part.

Primary objective:

Estimation of the toxicity of the combination of continuous low doses of Vinorelbine, Cyclophosphamide and Interferon alpha 2b.

Secondary objectives:

Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography (DEC-MRI), biology and immunohistochemistry of the treatment.


Eligibility criteria: Inclusion Criteria:

* patients aged from 18 and older,
* with metastatic or advanced solid tumor who received all standard treatments,
* who ended their chemotherapy or radiotherapy treatment within 4 weeks (6 weeks for mitocyne)prior entry in the study.
* All patients are included after being given written informed consent.

Exclusion Criteria:

* patients with stable disease,
* history or presence of another cancer,
* contraindication to administer the treatment,
* contraindication to perform MRI,
* pregnancy or breast feeding.

Primary outcomes:
measure: Estimation of the toxicity of the combination of continuous low doses of Vinorelbine, Cyclophosphamide and Interferon alpha 2b.
timeFrame: 6 weeks
Secondary outcomes:
measure: Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography (DEC-MRI), biology and immunohistochemistry of the treatment.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Anthony GONCALVES, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03827369: The Blood Pressure Analysis on Critically Ill Patients
Official title: The Blood Pressure Analysis on Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Organ Failure
Intensive Care Unit Syndrome
Keywords: Blood pressure
Arterial pulse
Coefficient of variation of harmonic magnitude
Lead sponsor: Taoyuan General Hospital
Sponsor class: OTHER_GOV
First posted: 2019-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients without severe arrhythmia admitted to the ICU of Taoyuan General Hospital.

Brief summary: The study is to explore the relationship between coefficient of variation of harmonic magnitude (HCV) and different organ failures among those critically ill patients. In the future, we can act as a warning system on patients with multiple organ failures or terminal illness, also as an indicator of treatment effect.


Eligibility criteria: Inclusion Criteria:

* ICU patients in the 20-to-99 age range
* Subjects agree to sign the Informed Consent Form and are willing to cooperate with Arterial pulse measurement

Exclusion Criteria:

* Subject has severe arrhythmia

Primary outcomes:
measure: Coefficient of variation of harmonic magnitude
timeFrame: 15 min
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan General Hospital, Ministry of Health and Welfare
Study officials:
affiliation: Taoyuan General Hospital, Minstry of Healthy and Welfare
name: Tzu-Yi Chuang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00121069: Study of Escitalopram in the Treatment of Specific Phobia
Official title: Placebo-Controlled Pilot Study of Escitalopram in the Treatment of Specific Phobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Phobic Disorders
Keywords: specific phobia
anxiety
SSRI
clinical trial
escitalopram
Lead sponsor: Connor, Kathryn M., M.D.
Sponsor class: INDIV
Collaborators: name: Forest Laboratories
First posted: 2005-07-21
Enrollment: 12
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: This pilot study is designed to assess the efficacy of escitalopram in the treatment of specific phobia in adult outpatients.

Detailed description: This double-blind placebo-controlled pilot trial study is designed to assess the efficacy of 12 weeks of escitalopram vs. placebo in the treatment of specific phobia in adult outpatients. It is hypothesized that escitalopram is safe and effective in the treatment of specific phobia.

Eligibility criteria: Inclusion Criteria:

* Adults 18-65 years of age
* DSM-IV criteria for specific phobia according to the MINI
* For women of childbearing potential, a negative serum pregnancy test at screening
* Written informed consent

Exclusion Criteria:

* Any current primary DSM-IV diagnosis other than specific phobia
* History of DSM-IV substance abuse or dependence within the last months
* Lifetime history of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation, or other pervasive developmental disorder or cognitive disorder due to a general medical condition
* Suicide risk or serious suicide attempt within the last year
* Clinically significant laboratory or EKG abnormality or unstable medical condition
* For women of childbearing potential, unwillingness to use an acceptable form of contraception during the study
* Subjects needing concurrent use of psychotropic medications

Primary outcomes:
measure: Response based on a criterion of 50% or greater reduction in the Marks Main Phobia Questionnaire and Marks Fear Questionnaire from baseline
Secondary outcomes:
measure: Response based on CGI-I category
Other outcomes:
Locations:
city: Durham
country: United States
facility: Dept of Psychiatry and Behvaioral Science, Duke Unviersity Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Kathryn M. Connor, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01408069: Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia
Official title: Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Tensional-type Headache
Keywords: headache
migraine
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2011-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 evaluate the non-inferiority clinical efficacy of two different associations of drugs in the treatment of patients diagnosed with tensional-type headache in accordance with International Headache Society guidelines.

Detailed description: * Open-label, non-inferiority, prospective, parallel group, intent to treat trial.
* Experiment duration: 56 days.
* 04 visits (days -7, 0, 28 and 56).
* Efficacy will be evaluated for 10 episodes of tension-type headache.
* Adverse events evaluation.

Eligibility criteria: Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Tensional-type headache patients according to the International Headache Society criteria.
3. Corporal body indices \< 40.

Exclusion Criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy.
4. Use of immunosuppressive drugs.
5. Alterations of laboratory selective tests.
6. Drugs or alcohol abuse

Primary outcomes:
measure: Efficacy of treatment in relieve headache symptoms.
timeFrame: 1 hour
Secondary outcomes:
measure: Tolerability of study treatment
timeFrame: 56 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05049369: Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
Official title: Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Tonsillar Hypertrophy
Sleep Apnea Syndromes
Keywords: tonsillectomy
obstructive sleep apnea
tonsil surgery
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2021-09-20
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults

Detailed description: The investigators are studying long-term efficiency of tonsillectomy in adults with obstructive sleep apnea caused by tonsillar hypertrophy. These patients have undergone tonsillectomy in 2004-2018 and now 3-17 years later investigators will perform new polysomnographies and compare these results with preoperative values. Especially the reduction in apnea-hypopnea index (AHI) will be evaluated. The quality of life and possible symptoms will be measured with questionnaires.

Eligibility criteria: Inclusion Criteria:

* age at least 16 during tonsillectomy
* preoperative obstructive sleep apnea and AHI (apnea-hypopnea index) \> 14
* tonsillectomy has been done because of the symptoms caused by tonsillar hypertrophy (ICD-10 diagnostic codes G47.3, R06.5 or J35.1)
* in addition to tonsillectomy, patients may have undergone shortening of uvula and/or radio frequency ablation of soft palate

Exclusion Criteria:

* AHI \< 14
* in addition to tonsillectomy patient has undergone uvulectomy, uvulopalatoplasty, uvulopalatopharyngoplasty or mandibular advancement
* other, evaluated by investigator

Primary outcomes:
measure: Apnea-hypopnea index
timeFrame: 3-17 years
Secondary outcomes:
measure: Quality of life measured by Glasgow Benefit Inventory (GBI)
timeFrame: 3-17 years
measure: Quality of life measured by Epworth sleepiness scale (ESS)
timeFrame: 3-17 years
measure: Apnea-index (AI)
timeFrame: 3-17 years
measure: Snoring time
timeFrame: 3-17 years
measure: Oxygen Desaturation Index (ODI)
timeFrame: 3-17 years
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
state: Southwest Finland
Study officials:
affiliation: Department of Otorhinolaryngology, Turku University Hospital
name: Jaakko M Piitulainen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01517269: PETS-D (Parent Education Thru Simulation-Diabetes)
Official title: PETS-D (Parent Education Thru Simulation-Diabetes)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Keywords: Parent education
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hypothesis: Parents who receive Parent Education Thru Simulation-Diabetes (PETS-D) will have significantly higher diabetes knowledge (cognitive visual schemata), better technical and problem-solving competence and confidence, and lower fear and stress/anxiety levels; and provide better diabetes management at 14 weeks compared to those parents receiving standard diabetes education.


Eligibility criteria: Inclusion Criteria:

* parents 18 years and older who have a child newly diagnosed with type 1 diabetes mellitus (T1DM) from 5 years old to under 13 years of age

Exclusion Criteria:

* exclude children with developmental delays (such as Down Syndrome, Autism) or steroid induced diabetes (cancer treatment related or cystic fibrosis)
* exclude parents who require insulin treatment -or- those that have another child with TIDM

Primary outcomes:
measure: Change in baseline of Diabetes Knowledge
timeFrame: Baseline and 14 weeks
Secondary outcomes:
measure: Change in Baseline of Problem solving
timeFrame: Baseline and 14 weeks
measure: Change in Baseline of Diabetes management
timeFrame: Baseline and 14 weeks
measure: Change in Baseline of Diabetes self efficacy
timeFrame: Baseline and 14 weeks
measure: Change in Baseline of Fear of hypoglycemia
timeFrame: Baseline and 14 weeks
measure: Change in Baseline of Parent anxiety
timeFrame: Baseline and 14 weeks
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts, Worcester
state: Massachusetts
Study officials:
References:
citation: Sullivan-Bolyai S, Crawford S, Bova C, Lee M, Quintos JB, Johnson K, Cullen K, Hamm T, Bisordi J, Ramchandani N, Fletcher J, Quinn D, Jaffarian C, Lipman T, Melkus G. PETS-D: Impact on Diabetes Management Outcomes. Diabetes Educ. 2015 Oct;41(5):537-49. doi: 10.1177/0145721715598383. Epub 2015 Aug 5.