louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00055315: Treatment for Borderline Personality Disorder
Official title: A Cognitive Group Treatment for Borderline Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-02-26
Enrollment: 383
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 will expose patients to either a Systems Training for Emotional Predictability and Problem Solving (STEPPS) or treatment as usual (TAU) to determine the more effective therapy for treating borderline personality disorder.

Detailed description: Participants are randomly assigned to receive either Systems Training for Emotional Predictability and Problem Solving (STEPPS) or treatment as usual (TAU) for 20 weeks. STEPPS is a new cognitive behavioral treatment which involves skills training for emotion management and lifestyle behaviors as well as education for the affected individual's family members, friends, and professional caregivers. Participants are assessed at baseline and Weeks 4, 8, 12, 16, and 20. Interviews of patient's health care providers and family members and self-rating scales are used to assess patients. Follow-up assessments are made 1, 3, 6, 9, and 12 months after study completion. Participants must live within a reasonable driving distance of Iowa City, IA.

Eligibility criteria: Inclusion Criteria:

* Borderline Personality Disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Roy J. and Lucille A. Carver College of Medicine, University of Iowa
state: Iowa
Study officials:
References:
citation: Blum N, Pfohl B, John DS, Monahan P, Black DW. STEPPS: a cognitive-behavioral systems-based group treatment for outpatients with borderline personality disorder--a preliminary report. Compr Psychiatry. 2002 Jul-Aug;43(4):301-10. doi: 10.1053/comp.2002.33497.
citation: Black, D.W., Blum, N., Pfohl, B., & St. John, D: The STEPPS Group Treatment Program for Outpatients with Borderline Personality Disorder. Journal of Contemporary Psychotherapy 34:193-210, 2004.
citation: Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Clinical trial NCT00403715: Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease
Official title: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-27
Enrollment: 500
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: The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with Placebo when applied topically in subjects with dry eye disease.


Eligibility criteria: Inclusion Criteria:

* best corrected visual acuity in both eyes of at least +0.7
* six-month documented history of dry eye disease
* at least mild severity in 2 of the 4 dry eye symptoms
* unanesthetized Schirmer score of less than or equal to 7mm
* corneal fluorescein staining of greater than or equal to 4 (out of 15)

Exclusion Criteria:

* nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm
* ongoing contact lens wear
* current topical ophthalmic medication use

Primary outcomes:
measure: change in dry eye testing measures and symptoms
Secondary outcomes:
measure: change in dry eye testing measures and symptoms
Other outcomes:
Locations:
Study officials:
name: Amy Schaberg, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT02235415: Observation of the Efficacy and Tolerance of Motens® (Lacidipine) in Patients With Essential Hypertension
Official title: Observation of the Efficacy and Tolerance of Motens® (Lacidipine) in Patients With Essential Hypertension, Under Normal Conditions Compared With an Open Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 24526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with essential Hypertension recruited by General practicioners, cardiologists and specialists in internal medicine in non-Hospital practice

Brief summary: Study of the efficacy and tolerance of Motens® (lacidipine) in patients with essential hypertension. To obtain information on the dosage used in practice and the tolerance at the start of treatment (12 weeks)


Eligibility criteria: Inclusion Criteria:

Non-hospitalised patients of both sexes aged 18 years or more with essential hypertension requiring treatment according to the recommendations of the German League for Hypertension

Exclusion Criteria:

Patients who had the contraindications listed in the product information (the case report file contained a copy of the product information)

Primary outcomes:
measure: Assessment of efficacy by the investigator on a 4-point verbal rating scale based on changes in blood pressure
timeFrame: Up to 12 weeks after start of drug administration
measure: Assessment of tolerability by investigator on a 4-point verbal rating scale
timeFrame: Up to 12 weeks after start of drug administration
measure: Number of patients with adverse events
timeFrame: Up to 12 weeks after start of drug administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01339585: The Effect of Timing of Transcranial Direct Current Stimulation (tDCS) for Enhancing Learning During Cognitive Training
Official title: The Effect of Timing of Transcranial Direct Current Stimulation (tDCS) for Enhancing Learning During Cognitive Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects on Learning
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This project will investigate a novel strategy for enhancing cognitive training (CT). Specifically, the investigators aim to combine a non-invasive form of brain stimulation (tDCS) with CT. This study will examine the optimal time interval - whether tDCS should be administered either before or during CT.


Eligibility criteria: Inclusion Criteria:

* Participants will be healthy right-handed subjects aged 18 to 40 years.

Exclusion Criteria:

* Concurrent medication likely to affect mental performance,
* Current history of drug or alcohol abuse or dependence,
* Any psychiatric or neurological disorder,
* Recent head injury, or history of seizure or stroke.

Primary outcomes:
measure: Change in performance across each condition.
timeFrame: Over 2 days, with each condition conducted 1 month apart.
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: School of Psychiatry
state: New South Wales
Study officials:
References:
Clinical trial NCT01294085: Case Series Study of Biliary Tract Cancer Patients in Japan
Official title: Retrospective Analysis of the Difference of Prognosis Between Unresectable and Recurrent Biliary Tract Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Tract Cancer
Lead sponsor: Kansai Hepatobiliary Oncology Group
Sponsor class: NETWORK
First posted: 2011-02-11
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300

Brief summary: To assess the difference of prognosis between unresectable and recurrent biliary tract cancer and evaluate prognostic factors.

Detailed description: Most patients of biliary tract cancer have advanced disease at diagnosis and often relapse despite surgery. Combination therapy of gemcitabine and cisplatin could be a standard therapy for this kind of cancer with the evidence of phase III study compared with gemcitabine alone. However the prognosis and the tolerability of chemotherapy in the patients with recurrent biliary tract cancer after radical resection might differ from those of unresectable biliary tract cancer, because the dose intensity of chemotherapy can be influenced by adjuvant chemotherapy and/or hepatic resection.

Eligibility criteria: Inclusion Criteria:

* Unresectable or recurrent biliary tract cancer

Exclusion Criteria:

* None

Primary outcomes:
measure: One year survival rate
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival time
timeFrame: 3 years
measure: Number of participants with adverse events
timeFrame: 3 years
measure: Progression free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
Study officials:
affiliation: Osaka Medical Center for Cancer and CVD
name: Tatsuya Ioka, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06213285: APPEND-CT Registry
Official title: Cardiac Computed Tomography Following Watchman FLX Left Atrial APPENDage Closure
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Stroke, Ischemic
Device Related Thrombosis
Atrial Fibrillation
Keywords: Left Atrial Appendage Occlusion
Cardiac Computed Tomography
Watchman FLX
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Boston Scientific Corporation
First posted: 2024-01-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Watchman FLX implanted patients with a minimum of one early follow-up cardiac CT.

Brief summary: The APPEND-CT registry is an investigator-driven multicenter retrospective observational database intended to compile cardiac CT follow-up data after Watchman FLX device implantation and function as a platform for answering clinical and research questions within LAAC follow-up. The derived studies should support therapeutic decision-making, improve risk-stratification in LAAC and help generate hypotheses for potential future clinical intervention trials.

Detailed description: An investigator-driven multicenter retrospective observational database enrolling patients from high-volume North American and European centers. The database will include Watchman FLX implanted patients with a minimum of one follow-up cardiac CT performed within 45-120 days post-procedure. Additional timepoints may be entered. Cardiac CT scans are to be uploaded and will be analyzed by the core-lab at Aarhus University Hospital.

Investigator-reported findings will be systematically reported to the database. This includes information on baseline characteristics, preprocedural planning, implantation details, discharge medication, follow-up imaging and clinical endpoints of interest.

As a minimum, investigator-reported endpoints will be collected from patient registries at one-year follow-up by site-investigators. Endpoints of interest include ischemic stroke, systemic embolism, major bleeding, mortality, device-related thrombosis, pericardial effusion, vascular complications, and device migration.

Eligibility criteria: Inclusion Criteria:

* Watchman FLX LAAO
* A minimum of one follow-up cardiac CT performed within 30-120 days post-procedure.
* A minimum of one year clinical follow-up data

Primary outcomes:
measure: Ischemic stroke
timeFrame: Minimum 12 months
Secondary outcomes:
measure: Device-related thrombosis
timeFrame: Minimum 12 months
measure: Major bleeding
timeFrame: Minimum 12 months
measure: All-cause and cardiovascular mortality
timeFrame: Minimum 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Anders Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00584285: Corneal Topographer Fluorescein Patterns
Official title: Objective and Subjective Correlation Between Clinical Fluorescein Patterns and Theoretical Patterns Using the Medmont Corneal Topographer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 yrs of age or older with diagnosis of keratoconus and contact lens wearer

Brief summary: The objective of this study is to determine if corneal topography can be used to predict the fluorescein pattern of keratoconus lenses on the eye. A corneal topography image will be taken and the computer selected lens will be placed on the eye. After placement of the lens color photographs will be taken of the eye's fluorescein pattern and compared to the computer predicted pattern.

Detailed description: Subject population: keratoconus patients who have not undergone corneal surgery 100 subjects who come to UIHC for their contact lens care. We will approach them at their visit. We will not call potential participants from a database.

If topography is impossible to capture. Concommitant Corneal Disease Minors will be excluded

Eligibility criteria: Inclusion Criteria:

18 yrs of age or older with diagnosis of keratoconus and contact lens wearer

Exclusion Criteria:

Noncommittant corneal disease or surgery Inability to capture topography measurement

Primary outcomes:
measure: Number of Participants With an Observable Difference Between Virtual Versus Actual Fluorescein Patterns
timeFrame: Baseline first visit
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics - Dept. of Ophthalmology
state: Iowa
Study officials:
affiliation: University of Iowa
name: Christine W. Sindt, OD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szczotka LB. Clinical evaluation of a topographically based contact lens fitting software. Optom Vis Sci. 1997 Jan;74(1):14-9. doi: 10.1097/00006324-199701000-00015.
citation: Jani BR, Szczotka LB. Efficiency and accuracy of two computerized topography software systems for fitting rigid gas permeable contact lenses. CLAO J. 2000 Apr;26(2):91-6.
citation: Rabinowitz YS, Garbus JJ, Garbus C, McDonnell PJ. Contact lens selection for keratoconus using a computer-assisted videophotokeratoscope. CLAO J. 1991 Apr;17(2):88-93.
citation: Szczotka LB. Corneal topography and contact lenses. Ophthalmol Clin North Am. 2003 Sep;16(3):433-53. doi: 10.1016/s0896-1549(03)00054-3.
citation: Bufidis T, Konstas AG, Mamtziou E. The role of computerized corneal topography in rigid gas permeable contact lens fitting. CLAO J. 1998 Oct;24(4):206-9.
Clinical trial NCT05158985: Comparative Study Between Different Duty Cycles of Ultrasound Diclofenac Phonophoresis
Official title: Comparative Study Between Different Duty Cycles of Ultrasound Diclofenac Phonophoresis in Management of Chronic Lateral Epicondylitis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Undefined
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lateral epicondylitis is a tendinopathy injury involving the extensor muscles of the forearm. These muscles originate on the lateral epicondylar region of the distal humerus. the insertion of the extensor carpi radialis brevis is involved in most cases. Transdermal administration of an anti-inflammatory drug to specific area is one of the methods that used to decrease inflammation and increase cell metabolism

Detailed description: Lateral epicondylitis is a soft-tissue lesion of the tendinous origin of the wrist extensor muscles at their origin on the lateral humeral epicondyle. The extensor carpi radialis brevis is the area of most pathologic changes. It begins as a microtear of the tendinous origin of the wrist extensor muscles and results in degeneration and reactive granulation tissue formation. Activities involving prolonged or repeated gripping, wrist extension, forearm supination, and pronation cause eventual failure of the affected portion of the tendon. The mechanical failure of the tendon results in an ensuring tendinitis and symptoms of lateral epicondylitis. It is aggravated with movements of the wrist, by palpation of the lateral side of elbow, or by contraction of extensor muscles of the wrist.

There are different treatment methods for lateral epicondylitis. Initially, lateral epicondylitis has been treated with ice, rest, counterforce tennis brace and/or non-steroidal anti-inflammatory drugs. But when the condition is not responding to initial treatment physical therapy is initiated

Eligibility criteria: Inclusion Criteria:

1. Both sexes will be involved
2. Duration of the disease is more than 12 weeks.
3. Patient's age ranges from 20 to 40 years

Exclusion Criteria:

1. Diabetic patients.
2. Hypertension patients.
3. Pregnant women
4. Cardiovascular patients
5. Patients with malunion fractures
6. Patients with cervical Radiclopathy
7. Patients with olecranon bursitis

Primary outcomes:
measure: Visual analogue scale for pain intensity measurement
timeFrame: 4 weeks
measure: Hand grip dynamometer for hand grip measurement
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Emad MOHAMED
Study officials:
References:
Clinical trial NCT00152685: High Dose Hyperoncotic Serum Albumin for the Treatment of the Acute Phase of Severe Head Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Severe Head Injury
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.


Eligibility criteria: Inclusion Criteria:

* severe head injury (GCS \< 9) Next of kin informed consent

Exclusion Criteria:

* Cranio cerebral wound Pregnancy Hypoxemia (PaO2/FiO2\< 300 mmHg) Blood loss \> 1/2 blood mass Renal or cardiac failure,uncontrolled hypertension Head injury dating from more than 24 hours at the time of inclusion

Primary outcomes:
measure: Reduction of the daily median value of intracranial pressure
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Surgical intensive care. CHU
state: Cedex 9
city: Le Kremlin Bicêtre
country: France
facility: Neurosurgical intensive care. CHU Le Kremlin Bicêtre
city: Nancy
country: France
facility: Neurosurgical intensive care. CHU de Nancy
Study officials:
affiliation: Universitary hospital of Angers
name: Ter Minassian Aram, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitary hospital of Nancy
name: Audibert Gérard, MD, PhD
role: STUDY_CHAIR
affiliation: Universitary hospital of Le Kremlin Bicêtre
name: Vigue Bernard, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05482685: The Health-Promoting Behavior and Related Factors Among Home Care Attendants
Official title: The Health-Promoting Behavior and Related Factors Among Home Care Attendants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Promotion
Keywords: home care attendant
health-promoting behavior
health literacy
self-perceived health
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: home care attendants

Brief summary: Background: With the trend of aging population and increasing demand for long-term care, Taiwan's long-term care 2.0 policy places special emphasis on home care services to achieve the goal of local aging. This study focused on the health-promoting behaviors home care attendants and applied Pender's health promotion model theory to investigate the impact of home care attendants' self-perceived health and health literacy on health-promoting behaviors.

Objective: To investigate the current status of home care attendants' health-promoting behaviors and the correlation between self-perceived health and health literacy.

Methodology: A structured questionnaire was used to collect data from 150 eligible home care attendants in the northern region using self-perceived health, health literacy, and health-promoting behaviors scales. Multiple regression analysis was used to analyze the correlation between the independent variables and the dependent variables.

Expected contribution: The results of this study will help to understand the current status of health-promoting behaviors of home care attendants and the correlation with their self-perceived health and health literacy. It will also help to understand whether home care attendants have sufficient health literacy to maintain or improve their health status, and to understand the areas in which home care attendants' health-promoting behaviors are still inadequate, so as to suggest effective methods or strategies to improve health-promoting behaviors in the future.


Eligibility criteria: Inclusion Criteria:

1. have license or have received training and a certificate of completion.
2. have been working in home care for at least three months
3. agree to participate in the study.

Exclusion Criteria:

1. under 20 years of age.
2. non-national.

Primary outcomes:
measure: Survey questionnaire
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ku Shan-Ting, bachelor
role: STUDY_CHAIR
References: