louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02494349: The PK Study of the JLP-1207 and Solifenacin/Tamsulosin in Healthy Male Volunteers.
Official title: Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: LUTS(Lower Urinary Tract Symptoms)
Benign Prostatic Hyperplasia
Overactive Bladder
Keywords: α1-blockers
antimuscarinic agent
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-10
Enrollment: 54
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy male volunteers.

Detailed description: A randomized, open-label, single dose, two-way crossover study.

Eligibility criteria: Inclusion Criteria:

* 19\~45 years healthy male
* Body weight is over 55kg, BMI measurement 18.0kg/m\^2\~ 27.0kg/m\^2
* Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
* Researchers determined suitable volunteers through physical examination, laboratory tests

Exclusion Criteria:

* History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
* Sitting SBP\>150mmHg or \<100mmHg, sitting DBP\>100mmHg or \<60mmHg, after 3 minutes break
* An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
* Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)
* History of drug abuse
* Positive urine drug screening
* Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study.
* Donated blood within 60 days prior to the first administration day in this study.

Primary outcomes:
measure: AUClast, Cmax
timeFrame: 192 hours
Secondary outcomes:
measure: AUCinf
timeFrame: 192 hours
measure: Tmax
timeFrame: 192 hours
measure: t1/2
timeFrame: 192 hours
measure: CL/F
timeFrame: 192 hours
measure: Vd/f
timeFrame: 192 hours
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital(SNUH)
name: Kyung-sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01687049: Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Official title: A Prospective Study of Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: nonmetastatic
localized
prostate
active surveillance
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 60
Sex: MALE
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing statins which are known to inhibit cholesterol synthesis. Laboratory studies have also shown that RYR has direct effects on androgen dependent and androgen independent prostate cancer cells, inhibiting their growth. It is thought that RYR may have clinical benefit in those subjects with localized prostate cancer who have chosen to be managed by active surveillance.

Detailed description: Red yeast rice has been promoted as a safe and effective alternative to statin therapy in the treatment of hypercholesterolemia. Red yeast rice has the potential to slow prostate cancer growth by inhibiting cholesterol and androgen biosynthesis. There is a strong rationale for the use of RYR in patients being managed with active surveillance for localized, low risk, prostate cancer. To date, no human studies utilizing RYR in this setting have been reported.

Eligibility criteria: Inclusion Criteria:

* histologically diagnosis of prostate adenocarcinoma
* being monitored by active surveillance for favourable risk prostate cancer
* tumour material from most recent prostate biopsy available with sample
* scheduled to have an active surveillance mandated transrectal ultrasound (TRUS) guided biopsy within 6 - 12 months of Day 1 of the study

Exclusion Criteria:

* previous malignancy in the past 5 years
* no previous or concurrent treatment for prostate cancer
* inability to undergo TRUS biopsy
* ECOG \> 2
* known or previous history of liver disease

Primary outcomes:
measure: Expression of Ki-67 and p27 biomarkers
timeFrame: 6 months
Secondary outcomes:
measure: PSA kinetics
timeFrame: 6 months
measure: Presence of prostatic interepithelial neoplasia
timeFrame: 6 months
measure: Expression of hs-CRP and cardiac CRP
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Laurence Klotz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04004949: the Effect of Scapular Dyskinesia on the Scapular Balance Angle & Upper Extremity Sensorimotor Function in Spastic Stroke Patient. The Patients Were Diagnosed With the Lateral Scapular Slide Test, Fugl-Meyer Upper Extremity (FMUE) Scale Scores & Scapular Balance Angle Test (SBA).
Official title: The Effect of Scapular Dyskinesia on the Scapular Balance Angle & Upper Extremity Sensorimotor Function in Stroke Patients With Spasticity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Stroke Scapular Dyskinesia
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Sixty stroke patients were randomly selected from Kasr El-Aini Neurological Department, outpatient clinic of Faculty of Physical Therapy, Cairo University, October 6 university hospital.

Brief summary: to investigate the effect of Scapular dyskinesia on the scapular balance angle \& upper extremity Sensorimotor Function in spastic stroke patient.

Detailed description: Background: Post stroke Scapular dyskinesia leads to scapulohumeral pain \& dysfunction were associated with decreased motor function, somatosensory function, limited range of motion, and spasticity.

Objective: to investigate the effect of Scapular dyskinesia on the scapular balance angle \& upper extremity Sensorimotor Function in spastic stroke patient.

Methods: sixty patients from both sexes were participated in this study. All the patients were diagnosed as spastic stroke patients. The patients were divided into two equal groups; group A (30 patients): with high scapular dyskinesia scores, group B (30 patients): with low or no scapular dyskinesia scores. The patients were diagnosed with the Lateral scapular slide test using Palpation meter (PALM) device, Fugl-Meyer upper extremity (FMUE) Scale scores \& scapular balance angle test (SBA).

Eligibility criteria: Inclusion Criteria:

* patient diagnosed as stroke patient
* stroke onset at least 5 months prior to study enrollment and
* decreased sensorimotor function in the affected arm, but ability to use the arm to some extent in daily activities with functional to subfunctional manual muscle test
* age ranged from 35:50
* both sexes

Exclusion Criteria:

* difficulty to communicate or to understand test instructions
* other conditions that caused pain (for example fibromyalgia and arthritis)
* severe depression or other psychiatric symptoms
* patient with other upper limb musculoskeletal problems

Primary outcomes:
measure: the Lateral scapular slide test
timeFrame: 1 day
measure: Fugl-Meyer Assessment (FMA) scale
timeFrame: 1 day
measure: scapular balance angle (SBA):
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University
state: El-Sheikh Zayed City Giza 1133 Egypt
Study officials:
References:
Clinical trial NCT06432049: Endocrown Restoring First Permanent Molar in Children
Official title: Clinical and Radiographic Outcome of Endocrown Restoring First Permanent Molar in Children: Clinical Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comparing Different Types of Restorations for Restoring Endodontically Treated Permanent First Molar in Children
Keywords: Endocrown
CAD-CAM
Children
Ceramic
Molars
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Clinical and radiographic evaluation of endodontically treated first permanent molars in thirty children restored with three different restorations over 12 months

Detailed description: This study comprised 30 children, with age range of (10-13) years old, with endodontically treated first permanent molars. Participants were classified into three groups according to type and material of the final restoration. All selected children were assigned to either PMC group (n=10) restored with performed metal crowns (Stainless-steel Molar Crowns) , EMX group (n=10) endocrown fabricated from CAD-CAM lithium disilicate glass ceramic , COP group (n=10) endocrown fabricated from CAD-CAM reinforced composite. After cementation, all children were evaluated over one year; at one week post-operative, 6 and 12 months for the following criteria: radiographic findings, plaque index, periodontal index, parent satisfaction.

Eligibility criteria: Inclusion Criteria:

* Patient age ranging from 10-13 years old with closed apex.
* Normal occlusion without any para-functional habits.
* Decayed lower first molar.
* Supra-gingival margin was required after preparation.
* Absence of root fractures or cracks.

Exclusion Criteria:

* Difficulty to apply rubber dam for proper endocrown bonding.
* Lack of patient cooperation for post-operative recall and follow up.
* Bad oral hygiene

Primary outcomes:
measure: number of participants with pathological changes in radiographs
timeFrame: 6 months
measure: degree of parent satisfaction with different restorations
timeFrame: 6 month
measure: rate of plaque accumulation on different type of restorations
timeFrame: 6 months
measure: effect of different restoration on surrounding gingiva
timeFrame: 6 months
Secondary outcomes:
measure: number of participants with pathological changes in radiographs
timeFrame: 1 year
measure: degree of parent satisfaction with different restorations
timeFrame: 1 year
measure: rate of plaque accumulation on different type of restorations
timeFrame: 1 year
measure: effect of different restoration on surrounding gingiva
timeFrame: 1 year
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafr El Shaikh University
Study officials:
References:
Clinical trial NCT00379249: Rosuvastatin ORBITAL Germany
Official title: Effects of a Twelve Months ROSUVASTATIN Treatment Plus Additional Care (Drug Intake Adherence and Lifestyle Enhancing Initiatives ) Compared to ROSUVASTATIN Treatment Alone on Long-Term Disease-Related Costs in Patients With an Indication for Statin Treatment According to the Joint European Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: hypercholesterolemia
statin
compliance
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-09-21
Enrollment: 8000
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 primary objective of the study is to compare the effect of rosuvastatin therapy plus compliance initiatives and rosuvastatin therapy alone for 12 months (52 weeks) on long-term cumulative direct and indirect disease-related costs during the 36 month.


Eligibility criteria: Inclusion Criteria:

* high cholesterol with an indication for cholesterol-lowering medication (statins)

Exclusion Criteria:

* contra-indications for statin therapy

Primary outcomes:
measure: Cumulative direct/indirect disease-related costs were compared applying a societal perspective
measure: Costs include resource utilization for ambulatory, hospital, rehabilitative and nursing care, medication, physiotherapy, transportation, and productivity loss)
Secondary outcomes:
measure: Achievement of the 1998 European LDL-C goal of <115 mg/dL (3.0 mmol/L)
measure: Changes in the lipid profile and compliance with therapy.
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca Germany
name: Wolfgang Meyer - Sabellek, MD
role: STUDY_DIRECTOR
affiliation: Charité Berlin, Germany
name: Stefan Stefan Willich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muckelbauer R, Englert H, Rieckmann N, Chen CM, Wegscheider K, Voller H, Katus HA, Willich SN, Muller-Nordhorn J. Long-term effect of a low-intensity smoking intervention embedded in an adherence program for patients with hypercholesterolemia: Randomized controlled trial. Prev Med. 2015 Aug;77:155-61. doi: 10.1016/j.ypmed.2015.05.026. Epub 2015 Jun 4.
citation: Muller-Nordhorn J, Muckelbauer R, Englert H, Grittner U, Berger H, Sonntag F, Voller H, Prugger C, Wegscheider K, Katus HA, Willich SN. Longitudinal association between body mass index and health-related quality of life. PLoS One. 2014 Mar 26;9(3):e93071. doi: 10.1371/journal.pone.0093071. eCollection 2014.
Clinical trial NCT03638349: Actions & Insights Evaluating a Novel Diabetes Management Solution
Official title: Actions & Insights Evaluating a Novel Diabetes Management Solution.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus ( Type 1 and Type 2)
Lead sponsor: LifeScan Scotland Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-20
Enrollment: 163
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 150 male or female subjects with Type 1 or Type 2 Diabetes Mellitus.

Brief summary: Single visit outcome study to obtain qualitative and quantitative data for a new BGMS.

Detailed description: During ASCEND, patients will complete a single visit clinical study divided into two distinct parts. Part 1 involves each subject completing a number of simple quantitative exercises to gauge their level of comprehension of diabetes related information. Subjects will then continue during the same visit to complete part 2 which involves gathering qualitative feedback from each subject on the new Blood glucose monitoring system.

Eligibility criteria: Summary off:

Inclusion Criteria:

* Diagnosed with T1DM or T2DM
* Performs SMBG
* Male or female, at least 16 years old.
* Able to communicate (speak, read and write) in English
* Willing to sign an informed consent.

Exclusion Criteria:

* Unlikely to be compliant with the study in the opinion of study staff.
* Conflict of Interest - Prospective Participants are currently working for, previously worked for, or have an immediate family member currently working for a company that manufactures or markets the products tested under this procedure

Primary outcomes:
measure: Scaled preference questionnaires on new blood glucose monitoring digital tool.
timeFrame: 1 hour
Secondary outcomes:
measure: Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 1 subjects.
timeFrame: 1 hour
measure: Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 2 subjects.
timeFrame: 1 hour
measure: Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject A1c.
timeFrame: 1 hour
measure: Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject subject numeracy.
timeFrame: 1 hour
measure: Preference questionnaires on new blood glucose monitoring digital tool based on insulin or non-insulin using subjects
timeFrame: 1 hour
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Inverness
country: United Kingdom
facility: Highland Clinical Research Facility
Study officials:
affiliation: LifeScan Scotland Ltd
name: Mike Grady
role: STUDY_DIRECTOR
References:
Clinical trial NCT03890549: Validation of Downloadable Mobile Snore Applications by Polysomnography (PSG)
Official title: Validation of Downloadable Mobile Snore Applications by Polysomnography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Apnea, Obstructive
Snoring
Keywords: obstructive sleep apnea
polysomnography
smart phone application
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed as obstructive sleep apnea no matter disease severity.

Brief summary: The aim of this study is to validate the downloadable mobile snore applications by polysomnography.

Detailed description: Obstructive sleep apnea(OSA) is characterized by multiple episodes of upper airway collapse during sleep and considered as a major health issue worldwide due to comorbidity with obesity, hypertension, diabetes and more advanced cardiovascular diseases. The noisy sounds of snoring caused by OSA bother bed partner sleepless and lead to long-term health problems. Mobile snore applications are convenient and accessible for patients to monitor the progress of OSA by themselves, but there are no reliable PSG-validated applications.

Eligibility criteria: Inclusion Criteria:

* Willing to sign inform consent with aged more than 20 years old
* Mild to moderate OSA, AHI (apnea-hypopnea index) \< 30

Exclusion Criteria:

* Significant lung disease
* Skeletal facial framework problems
* Central apnea
* Receiving acupuncture in recent 2 weeks
* Taking hypnotic drugs

Primary outcomes:
measure: snore time
timeFrame: through study completion during sleep, each sleep cycle about 6-8 hours
measure: snore counts
timeFrame: through study completion during sleep, each sleep cycle about 6-8 hours
measure: snore sound
timeFrame: through study completion during sleep, each sleep cycle about 6-8 hours
measure: sleep time
timeFrame: through study completion during sleep, each sleep cycle about 6-8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT01549249: Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
Official title: Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Keywords: cone outer segment tips line
inner segment/outer segment junction line
optical coherence tomography
epiretinal membrane
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 333
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The recovery of the cone outer segment tips (COST) line after epiretinal membrane (ERM) surgery using spectral-domain optical coherence tomography (SD-OCT) was assessed.

Detailed description: Epiretinal membrane (ERM) may cause decreased central vision or metamorphopsia. Pars plana vitrectomy with membrane peeling has become the standard treatment for epiretinal membrane. However, visual recovery or symptomatic relief is not always satisfactory in all eyes despite successful membrane removal. Spectral domain optical coherence tomography (SD-OCT) is a non-invasive imaging device for various vitreoretinal diseases. Cone outer segment tips (COST) line is a line observed between IS/OS line and RPE in SD-OCT. The investigators examined the correlation of visual acuity and the recovery of photoreceptor layer after ERM surgery, taking COST line into account as a new parameter

Eligibility criteria: Inclusion Criteria:

* Patients who received epiretinal membrane surgery between June, 2008, and November, 2010, at Kyorin Eye Center.
* Only eyes with postoperative follow-up period more than 6 months were included.

Exclusion Criteria:

* Eyes with secondary epiretinal membrane (previous history of uveitis, intraocular surgery, pre-operatively noted retinal breaks, etc.) were excluded.

Primary outcomes:
measure: best-corrected visual acuity
timeFrame: one year
Secondary outcomes:
measure: Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography
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:
citation: Itoh Y, Inoue M, Rii T, Hirota K, Hirakata A. Correlation between foveal cone outer segment tips line and visual recovery after epiretinal membrane surgery. Invest Ophthalmol Vis Sci. 2013 Nov 5;54(12):7302-8. doi: 10.1167/iovs.13-12702.