louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01041157: Botulinum Toxin Injection Efficiency
Official title: Effectiveness of Botulinum Toxin Injection After Exercising Splenius Capitis Muscle in Patients With Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Torticollis
Muscle Spasticity
Keywords: Torticollis
Botulinum Toxins
Lead sponsor: Jyväskylä Central Hospital
Sponsor class: OTHER
Collaborators: name: Eurostars
First posted: 2009-12-31
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the effect of the botulinum toxin injection into muscle tone, strength and mobility with and without muscle exercise effect.

Detailed description: The purpose is also to find out patients subjective symptoms between injections. Hypothesis: Efficiency of the botulinum toxin is more powerful with the muscle exercise before injection.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cervical dystonia
* Spasticity in splenius capitis muscle
* Regular treatment with botulinum toxin injection

Exclusion Criteria:

* Don't want to take part the Trial
* Very long distance from home to Jyväskylä Central Hospital

Primary outcomes:
measure: Muscle tone in splenius capitis muscle
timeFrame: five months
Secondary outcomes:
measure: Pain in the neck
timeFrame: five months
measure: Mobility in the neck
timeFrame: five months
measure: Neck muscle strength
timeFrame: five months
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Helth Care District
Study officials:
affiliation: Senior physician
name: Jari Ylinen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04726657: Comparison of Two Biphasic Insulin Regimens
Official title: Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes mellitus type 2
glycemic control
glycated albumin
continuous glucose monitoring
fructosamine
glycated hemoglobin
insulin
premixed human insulin
premixed insulin analog
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2021-01-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over
Primary purpose: TREATMENT

Brief summary: Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices

Detailed description: A cross-over study of 36 well controlled people with type 2 Diabetes Mellitus who underwent 7-day Continuous Glucose Monitoring with Premixed Human Insulin 30/70 and subsequently with Biphasic Aspart 30.

Eligibility criteria: Inclusion Criteria:

* regular attendees of Outpatient Clinic of the Diabetes Centre of the 1st Department of Internal Medicine of University Hospital in Thessaloniki Greece
* The patients were on Premixed Human Insulin 30/70 twice daily with or without metformin
* baseline HbA1c\<7%

Exclusion Criteria:

* the presence of type 1 Diabetes Mellitus
* stage 4 Chronic Kidney Disease
* use of antidiabetic medications other than insulin and metformin
* major cardiovascular event during the last six months
* acute illness and hospitalization during the last two weeks
* pregnancy
* absence of good metabolic control assessed with self-monitoring of blood glucose during the week before entering the study (\>20% of the measurements \<80mg/dl or \>130mg/dl)
* inability of the patients to understand the study procedures and sign the consent form

Primary outcomes:
measure: Change in average blood glucose
timeFrame: 7 days
measure: Glycated Albumin
timeFrame: 7 days
measure: Fructosamine
timeFrame: 7 days
Secondary outcomes:
measure: Daily Insulin requirements
timeFrame: 7 days
measure: nocturnal average blood glucose
timeFrame: 7 days
measure: Time in range
timeFrame: 7 days
measure: time above 180
timeFrame: 7 days
measure: time below 70
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: AHEPA Hospital Aristotle University Of Thessaloniki
name: Triantafyllos Didangelos, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04123457: Biorepository of Biomarkers for Optimization of Microvascular Treatment of Lymphedema
Official title: Biorepository for Discovery and Validation of Biomarkers for Optimization of Microvascular Treatment of Lymphedema
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lymphedema
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 100
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: Subjects with a diagnosis of Lymphedema.

Brief summary: Researchers are collecting information, saliva, blood and tissue from subjects with lymphedema to store for future research.


Eligibility criteria: Inclusion Criteria:

* Adult (18+ years of age)
* Ability to provide written consent
* Has been diagnosed with Lymphedema

Exclusion Criteria:

* Under the age of 18 years old
* Inability to provide written consent
* Previous lymphovenous bypass or lymph node transfer surgery
* Major changes occur to co-morbid conditions
* Proven ICG or iodine allergy

Primary outcomes:
measure: Biospecimen Acquisition
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Antonio Forte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02537457: Bioequivalence Study of Rivaroxaban
Official title: Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 15 mg and a Rivaroxaban Granule 15 mg in Japanese Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Embolism, Atrial Fibrillation and Venous Thrombosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-09-01
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of rivaroxaban 15 mg in healthy adult male subjects.


Eligibility criteria: Inclusion Criteria:

* Japanese healthy male subjects
* 20 to 40 years of age
* 17.6 to 26.4 kg / m² of body mass index (BMI)

Exclusion Criteria:

* Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction
* Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia)
* Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
* Subject with known sensitivity to common causes of bleeding (eg nasal)

Primary outcomes:
measure: Cmax (maximum observed drug concentration in measured matrix after single dose administration)
timeFrame: Multiple time point up to 3 day
measure: AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))
timeFrame: Multiple time point up to 3 day
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 30 day
Other outcomes:
Locations:
city: Kumamoto
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01995357: The Influence of Baseplate Adhesive on the Degree of Leakage
Official title: The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colostomy Stoma
Ileostomy Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent and signed letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy/colostomy for at least 3 months
4. Have a stoma with a diameter between 15 and 36 mm
5. Be able to handle the products themselves
6. Be able to use a custom cut product
7. Normally experience faeces under the base plate at least 3 times during 2 weeks
8. Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut
9. Be willing to test the test products without using paste and/or ring
10. Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
11. Be suitable for participation in the investigation
12. Be able to present a negative result of a pregnancy test - for women of childbearing age

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
3. Are pregnant or breastfeeding
4. Are participating in other interventional clinical investigations or have previously participated in this investigation
5. Use irrigation during the investigation (flush the intestines with water)
6. Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)
7. Have a loop stoma
8. Have known hypersensitivity towards any of the test products (including adhesive remover)

Primary outcomes:
measure: Degree of Leakage
timeFrame: 10 (- 2 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03193957: An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis
Official title: An Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.


Eligibility criteria: Inclusion Criteria:

* Subjects are male or female aged 18-55 years at the time of signing the informed consent form.

Exclusion Criteria:

* Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.

Primary outcomes:
measure: The change in Injection site pain score at immediately post injection (within 1 minute)
timeFrame: at Week 1 and Week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: AI Centrum Medyczne
Study officials:
References:
citation: Rho YH, Rychlewska-Hanczewska A, Sliwowska B, Kim TH. Usability of Prefilled Syringe and Autoinjector for SB4 (An Etanercept Biosimilar) in Patients with Rheumatoid Arthritis. Adv Ther. 2019 Sep;36(9):2287-2295. doi: 10.1007/s12325-019-01027-z. Epub 2019 Aug 1.
Clinical trial NCT05234957: Symmetric vs Asymmetric BLR Recession in Management of Basic IXT With Ocular Dominance
Official title: Symmetric Versus Asymmetric Bilateral Lateral Rectus Recession in Management of Basic Intermittent Exotropia With Ocular Dominance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Exotropia
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to investigate ocular motor and sensory outcomes of two different strategies of lateral rectus recession; symmetric and asymmetric, in management of basic type intermittent exotropia with ocular dominance.

Detailed description: Surgical management of basic -type intermittent exotropia with a dominant eye is controversial. Some surgeons do traditional symmetrical bilateral lateral rectus recession, while other perform unilateral recess-resect procedure in the non-dominant eye. The aim of this study is to investigate the effect of two different strategies of bilateral lateral rectus recession; symmetrical recession in which the amount of recession is equally divided between both eyes, and asymmetrical recession, in which the amount of recession is 2mm more in the non-dominant. Outcome measures include ocular deviation at distant and near fixation, sensory status and complications.

Eligibility criteria: Inclusion Criteria:

* Basic-type intermittent exotropia
* Simulated distant-type intermittent exotropia

Exclusion Criteria:

* Alternating basic-type intermittent exotropia (no ocular dominance)
* Distant-type intermittent exotropia
* Convergence-insufficiency type intermittent exotropia
* Constant exotropia
* Sensory exotropia
* Deep amblyopia
* Paralytic or restrictive exotropia
* Previous extraocular muscle surgery

Primary outcomes:
measure: Ocular Alignment at Distant Fixation
timeFrame: one year
measure: Ocular Alignment at Near Fixation
timeFrame: one year
Secondary outcomes:
measure: Sensory Status (Stereopsis)
timeFrame: one year
measure: Sensory Status (Fusion)
timeFrame: one year
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: Qalyubiyya
Study officials:
affiliation: Benha University
name: Mohamed Farid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05580757: Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
Official title: Role of Pharmacists in Suicide Prevention: Needs Assessment Among Pharmacists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacist-Patient Relations
Suicide
Suicide, Attempted
Suicidal Ideation
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dutch-speaking Belgian public pharmacists or pharmaceutical technical assistants (FTA)

Brief summary: This study aims to examine the opinions and needs of pharmacists and pharmaceutical technical assistants (FTA) concerning their role as gatekeepers in suicide prevention.

The primary objective is to map the experiences and needs of (public) pharmacists and FTA with regard to suicide prevention.

The secondary objective is to be able to develop more targeted tools, interventions or trainings based on the results of the needs assessment in order to facilitate the role of (public) pharmacists and FTA as gatekeepers in suicide prevention.


Eligibility criteria: Inclusion Criteria:

* Working as a (public) pharmacist or pharmaceutical technical assistant (FTA)
* 18 years or older
* Access to a computer, tablet or mobile phone with internet access
* Dutch-speaking

Exclusion Criteria:

* Hospital pharmacists or industrial pharmacists are not included in this study and thus constitute an exclusion criterion.

Primary outcomes:
measure: Needs
timeFrame: Baseline. Completing the questionnaire will take approximately 15-20 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Flemish Centre of Expertise in Suicide Prevention, Ghent University
Study officials:
affiliation: University Ghent
name: Gwendolyn Portzky, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06043557: Patient Satisfaction and Reflection on Drain Placement
Official title: Patient Satisfaction and Reflection on Drain Placement in Abdominoplasty and Panniculectomy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Abdominoplasty
Panniculectomy
Keywords: Abdominoplasty
plastic surgery
panniculectomy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 50
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 research study is to evaluate the ideal drain placement in patients undergoing abdominoplasty or panniculectomy. There are currently no patient reported outcome measurements on ideal drain placement and this study aims to collect objective and patient reported measures to standardize ideal drain placement.

In this study a medially and laterally placed drain will be compared to each other in each study participant. In this study subject will have two drains. One will be lateral and one medial. The drains will be secured and dressed in the same manner. At subjects planned post-operative visits, subjects will be asked to complete surveys to evaluate their experience with the drains. This study will not require additional clinic visits for study purposes.

Detailed description: The primary goal of this proposal is to assess patient perspectives and satisfaction with the location of their drains after abdominoplasty and/or panniculectomy. This will be conducted as a prospective observational trial, where patients with scheduled abdominoplasty and/or panniculectomy will be invited to participate. Patients will be randomized to either A) left side lateral and right side medial or B) right side lateral with left side medial. Randomization will occur before study initiation with group A or group B being assigned to a study enrollment number.

Eligibility criteria: Inclusion Criteria:

* age 18 or older
* patient of Department of Plastic and Reconstructive Surgery
* able to sign English language Consent form
* undergoing either abdominoplasty and/or panniculectomy.

Exclusion Criteria:

* Patients with unilateral drain placement, unable to sign English language consent form
* Patient under the age of 18.

Primary outcomes:
measure: Patient preference of surgical drain placement
timeFrame: 1 week post surgery
Secondary outcomes:
measure: Number of days until drain removed
timeFrame: day of surgery up to 10 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Adam Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03789357: Prevalence of Primary Aldosteronism in Patients With Stroke
Official title: Prevalence of Primary Aldosteronism in Patients With Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Aldosteronism
Stroke
Keywords: Hypertension
Arrhythmia
Adrenal vein sampling
Mineralocorticoid-receptor Antagonists
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective study to evaluate the prevalence of primary aldosteronism in patients with an acute stroke. 300 patients admitted with CVA/TIA will be enrolled into the study.

Brief summary: Strokes leads to significant morbidity and mortality, and hypertension is the most important risk factor for strokes. It is estimated that up to 10% of patients with hypertension have the underlying, treatable condition of primary aldosteronism. Hence, we hypothesize that the prevalence of primary aldosteronism is high in patients with strokes, a complication of long-standing hypertension.

Patients admitted with an acute stroke to the Acute Stroke Unit, Changi General Hospital, will be screened for Primary Aldosteronism three months post-stroke, and confirmatory tests will be done with saline-infusion test.


Eligibility criteria: Inclusion Criteria:

1. Age 21-80 years
2. Admitted with acute cerebrovascular accident (CVA) or transient ischemic attack (TIA) to the ASU, CGH
3. Patients with both ischemic and hemorrhagic strokes

Exclusion Criteria:

a. Pregnant patients

Primary outcomes:
measure: Percentage of patients with stroke with confirmed primary aldosteronism in patients admitted to the acute stroke unit for stroke
timeFrame: 6 months
Secondary outcomes:
measure: Accuracy of Screening test in early period post-stroke
timeFrame: 3 months
measure: Percentage of unilateral primary aldosteronism in patients admitted with acute stroke
timeFrame: 6 months
measure: Percentage of patients with positive screening test in patients admitted with acute stroke
timeFrame: 3 months
measure: Blood pressure change after treatment for primary aldosteronism
timeFrame: 12 months
measure: Cardiac Complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Troy Puar, MRCP UK
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen V, Tu TM, Mamauag MJB, Lai J, Saffari SE, Aw TC, Ong L, Foo RSY, Chai SC, Fones S, Zhang M, Puar TH. Primary Aldosteronism More Prevalent in Patients With Cardioembolic Stroke and Atrial Fibrillation. Front Endocrinol (Lausanne). 2022 Apr 19;13:869980. doi: 10.3389/fendo.2022.869980. eCollection 2022.