louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01959802: Foveal Cone Outer Segment Tips Line Defect in Macular Pseudohole
Official title: Correlation Between Foveal Cone Outer Segment Tips Line Defect and Visual Acuity After Surgery for Macular Pseudohole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Psudohole
Keywords: Macular pseudohole
Cone outer segment tips line
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 22
Sex: ALL
Minimum age (years): 10
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after surgery for macular pseudohole


Eligibility criteria: Inclusion Criteria:

* The patienst with macular pseudo hole

Exclusion Criteria:

* The patients with follow-up less than 6 months

Primary outcomes:
measure: Optical coherence tomography
timeFrame: one year
Secondary outcomes:
measure: Visual acuity
timeFrame: one year
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin Eye Center
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Makoto Inoue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00217802: The Effect of Self-regulatory Education on Women With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The project evaluates an innovative educational intervention using telephone counseling based on self-regulation theory designed to address a problem heretofore overlooked in asthma self-management education: the unique needs of adult female patients.

Detailed description: BACKGROUND:

More than half of the adults with asthma in the US are female. Prevalence of asthma in women appears to be increasing, and morbidity and mortality rates for this group are significantly higher than rates for men. Recent studies point to unique features in women's management of asthma potentially attributable to gender. These include, for example, factors associated with hormonal cycles, (e.g. menses, pregnancy, menopause) and social roles (e.g. household tasks exposing one to environmental triggers, caregiving to children and relatives interfering with asthma management etc.) To date, no rigorously evaluated intervention expressly designed for women with asthma has been reported in the literature.

DESIGN NARRATIVE:

This study is to assess the effectiveness of a gender-specific telephone counseling, self-regulation intervention for women with asthma. To test our hypothesis we employed a randomized controlled design utilizing an intervention group and a control group. The primary outcomes are gender-related asthma management problems, health care utilization, days having symptoms, self-regulation level, management skill, and quality of life. We measure at three time points: baseline before randomization; follow-up I, one year subsequent to randomization; and follow-up II, one year subsequent to follow-up.

Eligibility criteria: The study participants are a noninstitutionalized ambulatory sample of women who are willing to participate in the project and meet the following criteria:

1. 18 years of age or older,
2. a diagnosis of asthma,
3. presence of active symptoms,
4. enrolled as a patient in one of the University of Michigan Medical Center asthma-related clinics,
5. listed as having received face-to-face instructions by clinic personnel on peak flow monitoring and proper use of medicine and delivery devices, and
6. not pregnant.

Women who are found to have extenuating circumstances that would prevent them from fully benefiting from the program (e.g., mental illness or terminal illness) are excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Noreen Clark
References:
Clinical trial NCT01070602: The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraoperative Floppy Iris Syndrome
Keywords: IFIS
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-02-18
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intraoperative Floppy Iris Syndrome (IFIS) may occur during cataract surgeries in patients treated with alpha 1 blockers. IFIS related to alpha 1 blocker Tamsulosin (used for prostate hypertrophy) was reported in 50-90% of patients. IFIS during surgery make the surgery more difficult and raise complication rate.

Using anterior corneal incisions was reported briefly in literature as a prophylactic means but was not studied prospectively. we believe (according to our clinical experience) that these anterior incisions do help to reduce the incidence and severity of IFIS signs and complications rate during surgeries.


Eligibility criteria: Inclusion Criteria:

1. cataract candidates treated (in the present or in the past) with tamsulosin
2. aged 55 or more
3. candidates for topical anesthesia
4. no allergy to anticholinergic or adrenergic drugs
5. able to understand and sign an informed consent

Exclusion Criteria:

1. history of uveitis
2. iris neovascularization
3. s/p iris surgery
4. traumatic/uveitis induced cataract
5. dialysis / abscence of zonules

Primary outcomes:
measure: the number of IFIS cases observed during operation.
timeFrame: during the operations
Secondary outcomes:
measure: assessing the clinical grade of observed IFIS cases
timeFrame: during the operations
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT02716402: Cyanotic Heart Disease and Thrombosis
Official title: Cyanotic Congenital Heart Disease: Prevalence of Pulmonary and Cerebral Thrombi-embolic Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombosis
Keywords: Cyanotic congenital heart disease
pulmonary thrombosis
cerebral thrombosis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to examine previously examined patients with cyanotic congenital heart disease to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago.

Detailed description: Patients with cyanotic congenital heart disease have reduced oxygen content in their blood due to abnormal connection between the heart's right and left sides. The reduced oxygenation of the blood affects several organs of the body and a common complications to the disease is blood clots. Despite the patients are young and do not have typical risk factors, previous studies have shown, that they have a very high prevalence of thrombosis in the lungs and brain.

The reason for the increased prevalence of blood clots is not known. A previous study investigated the prevalence of blood clots systematically in patients with cyanotic congenital heart disease and found that approximately 30-40% of the patients had had a clot in the lung or brain. Thus, the study could not predict, when the patient had had a thrombotic event, and most of the patients did not previously had imaging performed. Therefore the aim of this study is to re-examine previously examined cyanotic patients regardless of previous medical history, to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago.

Eligibility criteria: Inclusion Criteria:

* Patients with cyanotic congenital heart disease who have previously participated in the study 'cyanotic congenital heart disease: Hemostatic abnormalities and clinical manifestations' (H-KF-2006-4068).
* Clinically stable

Exclusion Criteria:

* Patients who are not guardians for themselves (not adult).
* Age \<18 years.

Primary outcomes:
measure: Pulmonary and cerebral thrombosis
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: The total numbers of white matter hyper intensity lessons (WMHL)
timeFrame: Through study completion, an average of 1 year
measure: The size of the white matter hyper intensity lessons (WMHL)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Annette S Jensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00804102: Transcorneal Electrical Stimulation Therapy for Retinal Disease
Official title: Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-blind Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Macula Off
Primary Open Angle Glaucoma
Hereditary Macular Degeneration
Treated Retina Detachment
Retinal Artery Occlusion
Retinal Vein Occlusion
Non-Arthritic-Anterior-Ischemic Optic-Neuropathy
Hereditary Autosomal Dominant Optic Atrophy
Dry Age Related Macular Degeneration
Ischemic Macula Edema
Keywords: Retinitis pigmentosa
Macula off
Primary open angle Glaucoma
Hereditary Macular Degeneration
Treated Retina detachment
Retinal Artery Occlusion
Retinal Vein Occlusion,
Non-Arthritic-Anterior-Ischemic Optic-Neuropathy
Hereditary autosomal dominant Optic atrophy
dry Age-related Macular Degeneration
Ischemic Macula edema
Lead sponsor: Okuvision GmbH
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons.


Eligibility criteria: Inclusion Criteria:

* Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema

Exclusion Criteria:

* Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration
* Age above 99 years

Primary outcomes:
measure: enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University-Eye-Hospital, Centre for Ophthalmology, D-72076 Tübingen, Germany
name: Florian Gekeler, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schatz A, Rock T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun 23;52(7):4485-96. doi: 10.1167/iovs.10-6932.
citation: Naycheva L, Schatz A, Rock T, Willmann G, Messias A, Bartz-Schmidt KU, Zrenner E, Gekeler F. Phosphene thresholds elicited by transcorneal electrical stimulation in healthy subjects and patients with retinal diseases. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7440-8. doi: 10.1167/iovs.12-9612.
Clinical trial NCT01855802: Greek Physicians Perceptions Regarding Generics Prescribing in Glaucoma
Official title: Greek Physicians Perceptions Regarding Generics Prescribing in Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Greece
Ophthalmology
Glaucoma
Generics
Perception
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Greek Medical Council Members

Brief summary: This attempts to investigate the perceptions of Greek Ophthalmologists regarding generics prescription in glaucoma by means of a structured questionnaire.

Detailed description: The following dimensions will be recorded

1. Overall physician's empathy regarding generics in glaucoma
2. Physician's prescribing habits regarding generics in glaucoma
3. Physician's perceptions regarding generics cost-effectiveness in glaucoma
4. Physician's perceptions regarding adequacy of Greek regulatory authorities (generic market in glaucoma)
5. Physician's perceptions regarding adequacy of European regulatory authorities (generic market in glaucoma)

Eligibility criteria: Inclusion Criteria:

Licensed Registration to Greek Ophthalmology Council

Exclusion Criteria:

-

Primary outcomes:
measure: Generic Perception
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Democritus University of Thrace, Medical School
name: Georgios Labiris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labiris G, Fanariotis M, Kastanioti C, Alexias G, Protopapas A, Karampitsakos T, Niakas D. Greek Physicians' Perceptions on Generic Drugs in the Era of Austerity. Scientifica (Cairo). 2015;2015:251792. doi: 10.1155/2015/251792. Epub 2015 Sep 17.
Clinical trial NCT01601002: LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression
Official title: Does LEPR Polymorphism Predict Variability in Weight Gain Induced by Mirtazapine in the Treatment of Late Life Depression?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Mirtazapine
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Patients with an episode of depression in late life prescribed mirtazapine recruited from a clinical sample will be monitored for weight and receive a blood test during their usual course of treatment to determine polymorphisms in a specific gene (LEPR) thought to affect weight gain.


Eligibility criteria: Inclusion Criteria:

* patients older than 50 years
* meeting criteria for a diagnosis of major depressive disorder (DSM IV code 296.2x or 296.3x) as confirmed by a score \> 20 on the HAM-D 24 items scale and a structured clinical interview using the SCID by a consultant psychiatrist

Exclusion Criteria:

* Treatment resistant depression (as defined by failure to respond to ≥2 adequate antidepressant trials)
* Major depressive disorder with psychosis (296.x4)
* Those with depression who fulfill the chronic specifier (MDE for \>2 years)
* Significant Axis II pathology
* Previous trial with mirtazapine
* Concurrent antipsychotic usage
* Comorbid dementia (as confirmed by MMSE \< 24)
* Substance misuse including drug and/or alcohol dependence/abuse in the past 3 months
* Bipolar disorder
* Schizophrenia
* Obsessive compulsive disorder
* Post traumatic stress disorder
* Eating disorder
* Head injury
* Recent stroke (\< 3 months)
* Recent MI (\< 3 months)
* Currently actively participating in structured/formal psychotherapy
* Being non ambulatory
* Those actively suicidal
* Those incapable of informed consent

Primary outcomes:
measure: increase in weight as measured in the clinic
timeFrame: Weeks 1,2,4,8 and 12 weeks
Secondary outcomes:
measure: Proportion of population achieving clinical response as measured by rate of fall in HAM-D 24 item scores
timeFrame: Start to end of study (12 weeks)
measure: Proportion of patients achieving remission at end of study on HAM-D 24 (<11)
timeFrame: Start to end of study (12 weeks)
measure: Frequency of adverse events
timeFrame: Start to end of study (12 weeks)
measure: Percentage adhering to medication
timeFrame: Start to end of study (12 weeks)
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Akshya Vasudev, MBBS, MD, MRCPsych
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01238302: Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears
Official title: Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * The purpose of this study is to compare the clinical and anatomical outcomes of rotator cuff repair with Platelet-Rich Plasma(PRP) and conventional rotator cuff repair in treatment of large to massive rotator cuff tears.
* PRP application to arthroscopic rotator cuff repair would accelerate recovery after arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall satisfaction, and enhance structural integrity of repaired tendon.


Eligibility criteria: Inclusion Criteria:

large to massive rotator cuff tear as a determined by clinical examination and MR prior to surgery.

Exclusion Criteria:

* previous history of shoulder surgery
* acute trauma
* chronic dislocation
* pyogenic infection
* rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
* showed abnormal serological test results
* thrombocytopenia (platelets less than 15000 per microliter)
* had been received anti-platelet medication
* psychiatric problems that precludes informed consent or inability to read or write
* other serious problems that preclude participation of the study

Primary outcomes:
measure: structural integrity of repaired rotator cuff tendon
timeFrame: postoperative 9months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Study officials:
affiliation: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
name: Chris Hyunchul Jo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06118502: A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse
Official title: A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cigarette Smoking
Smoking Behaviors
Treatment
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-11-07
Enrollment: 544
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: An Adaptive, Multi-Randomization Design
Primary purpose: TREATMENT

Brief summary: This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each.

All visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.

Detailed description: Treatment seeking smokers across both Alabama and South Carolina (N=544) will be recruited and consented through established online methods and randomized to receive a 4-week course of either varenicline or combination NRT (patch + lozenge), counterbalanced. Using a concrete and measurable indicator of early treatment success (3 days non-smoking), smokers demonstrating early success at 4 week follow-up will continue with another four weeks of same medication, either varenicline or combination NRT. Those who do not demonstrate early success will be randomized to a subsequent 4-week course of either a) continuation of same medication, or b) switch to the other FDA approved option, either varenicline or combination NRT. The same process will repeat at Week 8, wherein treatment responders will continue with their ongoing medication and non-responders will be randomized to a final 4-week course of either a) continuation of same medication or b) switch to an e-cigarette. End of treatment outcomes will be assessed at Week 12 at which time no more product will be offered. Final follow-up at Week 24 will ascertain all primary (cessation) and secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Smokers who want to quit

Exclusion Criteria:

* Non-smokers

Primary outcomes:
measure: Non-responders after initial course of FDA-approved medication
timeFrame: 8 weeks
Secondary outcomes:
measure: Dependence and duration of longest quit attempt
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: