louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02949193: Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes
Official title: A Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 222
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 is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Detailed description: 1. Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks.
2. Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.

Eligibility criteria: Inclusion Criteria:

* Subjects with 6.5%≤HbA1c≤11.0% at screening
* Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening
* Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion Criteria:

* Subjects with fasting plasma glucose≥270mg/dL at screening
* Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
* Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening
* Subjects with ALT and AST 2.5 times or higher than upper normal range

Primary outcomes:
measure: HbA1c
timeFrame: Change from baseline at 24 week
Secondary outcomes:
measure: fasting plasma glucose
timeFrame: Change from baseline at 24 week
measure: HOMA-beta
timeFrame: Change from baseline at 24 week
measure: HbA1c response rate
timeFrame: Change from baseline at 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Sung Woo Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03294993: Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture
Official title: Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Blood Flow Indexes
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture
Primary purpose: SCREENING

Brief summary: The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography

Detailed description: The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography.The indexes include Arterial Diameter,Peak Systolic Velocity,End Diastolic Velocity,Resistive Index,Pulsatility Index,Systolic/End Diastolic Ratio,Time AverageMean Velocity and Blood Flow.

Eligibility criteria: Inclusion Criteria:

* Patients were included in the study if they were ethnic Chinese, between 18 and 65 years old, American Society of Anesthesiologists (ASA) physical status I or II,candidates for general anesthesia undergoing thoracic surgery

Exclusion Criteria:

* Patients were excluded if they do not want to cooperate with the test, had a history of upper extremity arteriosclerosis obliterans or thromboangitis obliterans,had a history of radial artery puncture or coronary artery bypass grafting,had acute vessel trauma,or had been diagnosed with Raynaud' disease,had suffered from mental or neurological disorders

Primary outcomes:
measure: The Change of Peak Systolic Velocity
timeFrame: baseline and 30 minutes after surgery
Secondary outcomes:
measure: the change of modified Allen test
timeFrame: baseline and 30 minutes after surgery
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Department of Anesthesiology
name: Hong Ma, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05943093: H19 in Acute Lymphoblastic Leukemia.
Official title: Expression of Long Non-Coding RNA H19 in Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Lymphoid Leukemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 96
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newly diagnosed ALL patients

Brief summary: * Study the expression level of H19 gene in the samples from ALL patients by real-time PCR.
* Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients.

Detailed description: Acute lymphoblastic leukemia (ALL) is the most common cancer affecting children and adolescents (Zeng XL et al, 2023). ALL is a haematological malignancy characterized by the malignant clonal expansion of lymphoid hematopoietic precursors (Hong Z et al, 2021). It arises from B- or T-lineage lymphoid progenitors: B-cell-precursor ALL (B-ALL) and T-cell ALL (T-ALL) (Brady SW et al., 2022). Rrelapse in ALL is the fundamental cause of treatment failure in 15-20% of patients (Hulleman E et al, 2009). Therefore, the exploration of novel functional molecules that play a role in ALL pathogenesis could be effective therapeutic targets for this disease (Asadi M et al, 2023).

Long non-coding RNAs (lncRNAs) are non-protein coding transcripts longer than 200 nucleotides (Kopp F et al, 2018). H19 was the first lncRNA to be discovered and submitted for genomic imprinting (Yoshimura H et al, 2018). It has a role in embryogenesis and tumorigenesis (Yoshimura H et al, 2014). It also has an indispensable role in enhancing cell proliferation, differentiation, migration, invasion, and chemo resistance (Li Y et al, 2020). Recent evidence has shown that H19 is an oncogene and is overexpressed in breast, liver, endometrial, lung, cervical, and esophageal cancers (Asadi M et al, 2023). A similar pattern of H19 expression was observed in various types of leukemias, including chronic myeloid leukemia (CML) (Morlando M et al, 2015) and acute myeloid leukemia (AML) (Zhang Tj et al, 2018).

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed ALL patients.

Exclusion Criteria:

- 1-Presence of other haematological disorders, history of other malignancies or relapsed ALL.

2-Patients under chemotherapy or radiotherapy.

Primary outcomes:
measure: - Study the expression level of H19 gene in the samples from ALL patients by real-time PCR.
timeFrame: baseline
Secondary outcomes:
measure: Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients.
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00432393: Effect of Levodopa-Carbidopa on Visual Function in Patients With Recent-Onset Nonarteritic Anterior Ischemic Optic Neuropathy
Official title: Effect of Levodopa-Carbidopa on Visual Function in Patients With Recent-Onset Nonarteritic Anterior Ischemic Optic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nonarteritic Anterior Ischemic Optic Neuropathy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-02-07
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: There are some controversies about the effect of Levodopa-Carbidopa on treatment of non-arteritic anterior ischemic optic neuropathy (NAION). This study was performed to evaluate the effect of Levodopa-Carbidopa on visual acuity, color vision, and visual field in patients with recent onset NAION (less than 6 weeks duration).

Patients and Methods: In this double-blind randomized clinical trial, 13 patients were treated with levodopa-carbidopa and 12 patients took placebo for 3 weeks. Visual acuity, color vision, and visual field were tested before and at 4th, 12th, 16th, and 24th weeks after enrollment, and evaluated.


Eligibility criteria: Inclusion Criteria:

* age greater than 50 years old
* first ophthalmic examination within 6 weeks after onset of disease
* presence of optic disc swelling followed by optic atrophy within 6 weeks
* altitudinal, central or generalized visual field defect
* normal ESR

Exclusion Criteria:

* confirmed giant cell arteritis
* history of any ocular surgeries
* optic neuropathy due to acute bleeding
* advanced diabetic retinopathy
* uncontrolled glaucoma
* any ocular disorders that cause visual acuity reduction rather than NAION

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic research center
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Mohammad Pakravan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03643393: Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure
Official title: Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Prolapse
Lead sponsor: Viet Duc University Hospital
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 2
Sex: MALE
Minimum age (years): 52
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Incarceration and necrosis of rectal prolapse is rare and often requires urgent management. Perineal rectosigmoidectomy (Altemeir procedure) is a reasonable technique for this condition. The need for a diverting stoma depends on the patient's condition and the experience and judgement of the surgeon. A literature review was performed to determine optimal management of incarcerated and necrotic rectal prolapse, and to determine the indication for fecal diversion.


Eligibility criteria: Inclusion Criteria:

* 2 cases incarceration rectalprolapse

Exclusion Criteria:

* N/A

Primary outcomes:
measure: recurrent rectal prolapse
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: center of colorectal surgery - viet duc university hospital
name: xuan hung nguyen, DR
role: STUDY_CHAIR
References:
Clinical trial NCT03257293: A Trial of a Modified Cystoscopy Method to Reduce Pain Perception
Official title: A Randomized Control Trial of a Modified Cystoscopy Method to Reduce Pain Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematuria
Bladder Cancer
Bladder Disease
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this project is to improve patient experience of cystoscopy using a non-pharmacologic modification of procedure. Cystoscopy is a common outpatient procedure for urology patients and is usually performed without sedation. However, there is limited research into reduction of patient discomfort throughout this procedure. The proposed modification technique was selected based on a well-documented psychological phenomenon in which only particular moments over the course of an aversive event determine the resultant perception of the experience. It is hypothesized that implementation of the technique will decrease the recalled pain intensity of the cystoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 undergoing cystoscopy for the first time for diagnostic investigation will be approached to participate in this study.

Exclusion Criteria:

* Cystoscopies involving other interventions concurrently (e.g. biopsy, urethral dilation, removal of ureteral stent, etc.) will be excluded.
* Patients currently taking medication for chronic pain (e.g. opioids, Tricyclic antidepressants (TCAs)) will be excluded from the study.
* Patients less than 18 years of age will be excluded.
* Patients who have received a cystoscopy previously will be excluded.

Primary outcomes:
measure: Pain Experience rated on the visual analogue scale
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Nicholas Power, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04568993: The TriggerHappy Trial
Official title: Patient-reported Outcome After Corticoid Injection for Triggerfinger- a Randomized Controlled Study Between Two Injection Procedures and Between Corticoid Injection and Percutaneous Release
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Trigger Finger
Trigger Thumb
Minimally Invasive Surgery
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized multicenterstudy focusing on PROMs after primary corticoid injection for triggerfinger with a comparison of two different injection techniques.

Detailed description: This study aims to compare two different methods of corticosteroid injections in patients with triggerfinger, and to study the effects of these injections by day-to-day self-assessment by the included study persons for four weeks. The patient assess: 1. Pain 2. Motion and 3. Triggering by VAS scale every day for four weeks.

Eligibility criteria: Inclusion Criteria:•

1. Triggering of one or more fingers and/or impaired active finger motion and/or pain during active finger motion
2. Localized tenderness volar to the MCP joint of the affected finger
3. The patient seeks treatment

Exclusion Criteria:

1. Previous treatment for triggerfinger in the finger to be treated
2. Impaired function of finger due to previous trauma/infection or other condition
3. Suspicion of other cause than triggeriinger/tendovaginitis
4. Patient not able to follow instructions

Primary outcomes:
measure: Pain after injection
timeFrame: Four weeks
measure: Impairment of finger motion
timeFrame: Four weeks
measure: Triggering
timeFrame: Four weeks
Secondary outcomes:
measure: Quick-DASH
timeFrame: Four weeks
Other outcomes:
Locations:
city: Alingsås
country: Sweden
facility: Alingsås Lasarett/ District Hospital
Study officials:
References:
Clinical trial NCT05979493: QL Block in Laparoscopic Myomectomy
Official title: Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Postoperative Pain
Fibroid Uterus
Keywords: QL Block
Myomectomy
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to significantly reduce postoperative pain levels in patients undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is becoming a standard of anesthesia and surgical care. Since participants will be undergoing a myomectomy procedure, the investigators believe that participants may qualify to participate in this study. The investigators will be comparing patients who receive the QL block (in addition to standard anesthesia and postoperative pain care) with patients who do not receive the QL block (in addition to standard care). The participants will be randomly assigned to one of the two groups and may or may not actually receive the block.


Eligibility criteria: Inclusion Criteria:

* Presence of uterine fibroids requiring surgical excision with preservation of the uterus
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Provision of signed and dated informed consent form

Exclusion Criteria:

* Pre-existing diagnoses of anxiety or depression
* Pre-existing coagulopathies
* Pre-existing neuropathic or chronic pelvic pain
* Chronic opioid use
* Illiteracy due to inability to read and understand plain questionnaire
* Non-English speaking
* BMI \>38

Primary outcomes:
measure: Time in minutes from first analgesic request as measured by medical chart review
timeFrame: Up to 24 hours
measure: Total number of doses of rescue analgesics given as measured by medical chart review
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Pain as measured by visual analog scale (VAS)
timeFrame: Up to 48 hours after discharge from hospital.
measure: Patient satisfaction with perioperative pain management measured on a scale of 1-10
timeFrame: Up to 48 hours after discharge from hospital.
Other outcomes:
measure: Pain as measured by Richmond Agitation Sedation Scale (RASS)
timeFrame: Up to 24 hours
Locations:
city: Beachwood
country: United States
facility: University Hospitals Ahuja Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals
name: Joseph Findley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00121693: The Use of Music Therapy in the Prevention of Falls
Official title: Posturographic Changes Associated With Music Therapy and Fall Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Accidental Falls
Healthy
Keywords: Fall prevention
posturography
music therapy
Lead sponsor: Carrick Institute for Graduate Studies
Sponsor class: OTHER
First posted: 2005-07-21
Enrollment: 266
Sex: ALL
Minimum age (years): 17
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether listening to music will demonstrate changes in human postural stability and whether those changes might be useful in fall prevention strategies.

Detailed description: Falls are a serious health issue and are the greatest cause of death in the elderly. The use of music therapy in fall prevention has not been reported in the literature. This investigation will provide experimental support to the assumption that music therapy may prevent falls and that certain music can affect increases in postural stability using randomly selected subjects, validated posturography and a full experimental design.

Computer dynamic posturography (CDP) tests will provide stability scores in volunteer subjects who have had no previous history of falls or vertigo. Subjects will be randomized into several different music listening groups and one control group. Examiners will be blinded as to the music listened to and the outcome measurements. Subjects will be blinded as to their posturographic measurements. The music listening groups will be given a daily specific music listening task. CDP tests will be obtained 10 minutes, 1 week and 1 month after subject's treatment. Music selection will include Mozart, Nolwenn Leroy and others suggested to change human stability.

Eligibility criteria: Inclusion Criteria:

* No history of previous fall(s) or dizziness

Exclusion Criteria:

* History of previous fall(s) or dizziness

Primary outcomes:
measure: Pretest and posttest scores will be collected for ten treatment conditions at three post-treatment times (10 minutes, 1 week, and 1 month)
timeFrame: Immediate pre and post balance testing
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Canaveral
country: United States
facility: Carrick Institute for Graduate Studies
state: Florida
Study officials:
affiliation: Carrick Institute for Graduate Studies
name: Frederick R Carrick, PhD, FACCN
role: STUDY_DIRECTOR
affiliation: Carrick Institute for Graduate Studies
name: Elena Ogerro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carrick Institute for Graduate Studies
name: Guido Pagnacco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrick FR, Oggero E, Pagnacco G. Posturographic changes associated with music listening. J Altern Complement Med. 2007 Jun;13(5):519-26. doi: 10.1089/acm.2007.7020.