louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01821846: Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus
Official title: A 6-month, Multi-centre, Open Labelled, Non-randomized, Non-interventional, Safety Study of Liraglutide (Victoza®) in Subjects With Type 2 Diabetes Mellitus in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-04-01
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Victoza® will be prescribed and titrated by the physician.

Brief summary: This trial is conducted in Asia. The aim of this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Subjects with T2DM (Type 2 Diabetes Mellitus), including newly-diagnosed subjects, who require treatment with Victoza® according to the clinical judgment of their treating physician
* Subjects (and/or parents or the subject's legally acceptable representative) who are capable of giving study-specific signed informed consent before any collection of information

Exclusion Criteria:

* Subjects with a hypersensitivity to Victoza® or to any of the excipients
* Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods
* Subjects with personal or family history of medullary thyroid carcinoma (MTC)
* Subjects with multiple endocrine neoplasia syndrome type 2 (MEN2)

Primary outcomes:
measure: The incidence of SADRs (Serious Adverse Drug Reactions)
timeFrame: Up to 6 months
Secondary outcomes:
measure: HbA1c (Glycosylated haemoglobin) change
timeFrame: Month 0, month 6
measure: Percentage of subjects reaching the target of HbA1c below 7.0%
timeFrame: Month 6
measure: Change in body weight
timeFrame: Month 0, month 6
measure: Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Pyungchon-Dong 896, Dongan-Gu
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Ulsan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Ulsan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Wonju
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03072446: Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.
Official title: Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroid
Embolization
Symptoms
Keywords: Uterine Fibroid
Embolization
symptoms
Gel-Beads
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Vascular Solutions LLC
First posted: 2017-03-07
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this post-market study is to evaluate UFE agents for the treatment of symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic agents.

Detailed description: This single-center, prospective study will be conducted at one site in the United Kingdom. Up to 30 subjects will be enrolled and treated with Gel-Bead. Prospectively. Enrolled Gel-Bead subjects will be followed at 1-month and 3-months post-procedure.

Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton. This study evaluated 20 subjects in five different treatment groups for the treatment of symptomatic uterine fibroids. The five treatment groups include gelatin foam slurry, Embospheres, polyvinyl alcohol (PVA), Bead Block and Embozenes.

Eligibility criteria: Inclusion Criteria:

1. Female, age 18 years or older
2. Symptomatic uterine fibroid(s) requiring treatment per the investigators assessment
3. Negative serum pregnancy test at the Baseline visit and practicing effective contraception during the study
4. Willing to provide written informed consent prior to initiation of study procedures
5. Willing to comply with the specified study assessments and follow-up requirements

Exclusion Criteria:

1. Known hypersensitivity to porcine products or intravascular contrast material
2. Vascular anatomy or blood flow precluding correct catheter placement or embolic injection
3. Presence of collateral vessel pathways potentially endangering normal territories during embolization

Primary outcomes:
measure: Degree of Fibroid Tissue Infarction at 3 months
timeFrame: 3 months
measure: Characterization of adverse events over 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change in uterine and dominant fibroid volumes
timeFrame: 3 months
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton University Hospital NHS Trust
state: Hampshire
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Nigel Hacking
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00170846: ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients
Official title: Assessment of Everolimus in Addition to Calcineurin Inhibitors Reduction in Maintenance Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: Renal transplantation, everolimus, calcineurin inhibitors, GFR
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 394
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 study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the maintenance of renal transplant recipients with renal impairment by reducing the progression of chronic allograft nephropathy. The development of atherosclerosis in the native arteries of the patients will also be explored.


Eligibility criteria: Inclusion Criteria:

* Male or female patient at least 18 years of age.
* Patient who has undergone a primary or secondary renal transplant 12-96 months ago from a living related or unrelated donor or a cadaveric donor.
* Patient receiving cyclosporine microemulsion with a C2-h level ≥ 400 ng/mL or tacrolimus with a C0-h level ≥ 4 ng/mL with or without mycophenolic acid or azathioprine plus or minus steroids.
* The immunosuppressive regimen must remain unchanged within the last 3 months.
* Patient with renal impairment defined as GFR between 30 and 70 mL/min/1.73 m\^2 by Cockcroft-Gault formula.

Exclusion Criteria:

* Patient who is recipient of multiple organ transplants.
* Patient with protein/creatinine ratio ≥ 150 (mg/mmol).
* Patient with a treated acute rejection episode within the last 3 months.
* Patient with any past or present BK-polyomavirus nephropathy.
* Patient with de novo or recurrent glomerular nephritis.

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Renal Function Assessed by Measured GFR (mGFR)
timeFrame: 24 months
Secondary outcomes:
measure: Number of Participants With Safety Parameters
timeFrame: 24 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT06140212: Exploring the Relationship Between ICOPE Framework and Frailty Among Community-dwelling Elderly Individuals
Official title: Exploring the Relationship Between the Integrated Care for Older People (ICOPE) Framework and Frailty Among Community-dwelling Elderly Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community-dwelling Elderly
Keywords: Frailty
ICOPE
Intrinsic capacity
Community-dwelling elderly
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 135
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Communities in Taipei city

Brief summary: This study aims to (1) compare the assessment outcome of the ICOPE-I and ICOPE-S, and (2) investigate the correlation between both versions of the ICOPE step 1 screening tools and frailty in Taiwan.

Detailed description: The prevalence of frailty among the elderly increases annually as the population ages. The World Health Organization (WHO) has introduced the Integrated Care for Older People (ICOPE) framework, which aims to support healthy aging by evaluating the intrinsic capacity (IC) of the elderly in six different areas. In Taiwan, two versions of the ICOPE step 1 screening tools are available: an interview-based version (ICOPE-I) and a self-administered version (ICOPE-S) based on the WHO's model. There are two main models for frailty status assessments: Dr. Fried's phenotype of frailty and Dr. Rockwood's accumulation of deficit models. A comparative study is necessary to assess the consistency of both versions of ICOPE in Taiwan and their associations with frailty.

Eligibility criteria: Inclusion Criteria:

* ≥ 65 years old
* Community-dwelling elderly
* Walking independently (with/without assistive devices)

Exclusion Criteria:

* Participants with a MoCA score \< 26
* Being unable to give informed consent (e.g., aphasia, deafness, and blindness)
* Being unable to finish all the physical and screening assessment assessments

Primary outcomes:
measure: Intrinsic capacity
timeFrame: The ICOPE screening tool assessment would take about 10 minutes
measure: Phenotype of frailty status
timeFrame: The phenotype of frailty status assessment would take about 10 minutes
measure: Accumulated frailty status
timeFrame: The accumulated frailty status assessment would take about 10 minutes
Secondary outcomes:
measure: Cognitive status
timeFrame: The cognitive status assessment would take about 10 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
state: Zhongzheng
Study officials:
affiliation: National Taiwan University
name: Li-Ying Wang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06629012: Autologous Nerve Graft Breast Reconstruction Neurotization
Official title: Breast Neurotization During Breast Reconstruction Enhances Quality of Life
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Reconstruction
Breast Cancer Patients
Nipple-sparing Mastectomy
Keywords: breast reconstruction
nipple-sparing mastectomy
breast neurotization
quality of life
autologous nerve graft
nipple sensation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 250
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing nipple-sparing mastectomy and immediate breast reconstruction

Brief summary: The goal of this observational study is to learn about the improvement of quality of life in accordance with breast neurotization in breast cancer patients. The patient-reported outcome was assessed by questionnaire.


Eligibility criteria: Inclusion Criteria:

* Patient who receive breast reconstruction
* Patient who is willing to fill in the questionnaire

Exclusion Criteria:

* Patient who receive breast reconstruction for the reason other than breast cancer

Primary outcomes:
measure: Pre-operative Quality of life
timeFrame: Before breast reconstructive surgery
measure: Post-operative-two-year Quality of life
timeFrame: Two-year after breast reconstructive surgery
measure: Post-operative-one-year Quality of life
timeFrame: One-year after breast reconstructive surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT01070212: Effects of Gum Chewing on Appetite and Digestion
Official title: Effects of Gum Chewing on Appetite and Digestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Null Hypothesis is That Food Rheology Will Have no Effect on These Indices
The Alternate Hypothesis is That Increased Mechanical Stimulation Will Result in Stronger Satiation/Satiety and Reduced Energy Intake
It is Hypothesized That the Effects of Mastication Will be Less Evident in Obese Compared to Lean Individuals
Keywords: human, chewing, appetite,
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: One obvious property difference between energy-yielding beverages and solid foods is the oral mechanical processing required to prepare the two food forms for swallowing. Considerable human data are consistent with a contribution of mechanical stimulation to appetite suppression. However, no study has isolated this property and assessed its influence on ingestive behavior in humans. This is the aim of the present study. The null hypothesis is that food rheology will have no effect on these indices. The alternate hypothesis is that increased mechanical stimulation will result in stronger satiation/satiety and reduced energy intake. Further, it is hypothesized that the effects of mastication will be less evident in obese compared to lean individuals.


Eligibility criteria: Inclusion Criteria:

* body mass index 18 -25 or 30-35 kg/ m2 good health not initiating or terminating the use of medications reported to affect appetite or body weight during the proposed study period stable activity level (no deviation \> 1X/wk @ 30 min/session) no eating disorder (score \<20 of the Eating Attitude Test (EAT-26) no allergies to test foods. not glucose intolerant or diabetic (based on fasting blood glucose between 70-99mg/dl (3.9-5.5mmol/l as recommended by the American Diabetes Association.) no history of GI pathology and self-reported consumer of breakfast and lunch.

Exclusion Criteria:

-

Primary outcomes:
measure: Effects of mastication on appetite.
timeFrame: 12 hours
Secondary outcomes:
measure: Endocrine response
timeFrame: 4 hours
measure: Blood chemistries
timeFrame: 4 Hours
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
Clinical trial NCT05317312: Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Response Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Post Operative Pain
Pain
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 111
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: MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery.


Eligibility criteria: Inclusion Criteria:

1. Males and females ≥18 years of age.
2. Requirement for dental surgery for extraction of ≥2 third molars, at least 1 of which involves partial or complete mandibular bony impaction.
3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours following the end of surgery in the eligibility assessment as well as in the baseline assessment immediately pre-dosing.
4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following the end of surgery.

Exclusion Criteria:

1. Previously dosed with MR-107A-02.
2. Subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).
3. Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis,or bleeding disorders that may affect coagulation.
4. Moderate or severe hypertension, prior stroke or transient ischemic attack.
5. Use of any investigational drug within 28 days, or 5 half-lives, prior to consent whichever is longer.
6. Use of medications with the potential to interact with MR-107A-02.
7. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator.

Primary outcomes:
measure: Overall Summed Pain Intensity Difference (SPID)
timeFrame: 24 hours after the first dose
Secondary outcomes:
measure: Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF)
timeFrame: 24 hours after first dose
measure: Time to Perceptible Pain Relief.
timeFrame: 24 hours after first dose
measure: Time to Meaningful Pain Relief
timeFrame: 24 hours after first dose
measure: Patient's Global Assessment of Pain Control
timeFrame: 24 hours
measure: Rescue Medication Use
timeFrame: 24 hours after first dose
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Research Facility 201
state: Utah
Study officials:
References:
Clinical trial NCT03420612: Factors Associated With Pain During Unsedated Colonoscopy
Official title: A Novel Intubation Discomfort Score Identifies Patients Feeling Painful During Unsedated Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Unsedated
Pain
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 607
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients of the training cohort were enrolled form Xijing Hospital of Digestive Diseases. The patients of the validation cohort were enrolled from the Shaanxi Second People's Hospital.

Brief summary: Colonoscopy is the gold standard in the diagnosis and treatment colorectal disease, but due to the uncomfortable or even painful procedure, a part of people unwilling to undergoing the examination and giving analgesic agents were recommended in several guidelines. However, use of analgesic agents have their own drawbacks, and nearly 70% patients felt no pain or only mild discomfort with the unsedated colonoscopy, routine administration of sedative or analgesic agents to all patients was considered as unnecessary. However, unsedated colonoscopy was thought to be an option for some but not for all, therefore a method to identify which patients at high risk for painful colonoscopy in preoperational stage is necessary.


Eligibility criteria: Inclusion Criteria:

* aged 18-80 years
* underwent unsedated colonoscopy

Exclusion Criteria:

* no bowel preparation or colon cleansing by enema only
* no need to reach cecum
* prior finding of severe colon stenosis or obstructing tumor
* history of colectomy
* unstable hemodynamics
* pregnant
* unable to give informed consent.

Primary outcomes:
measure: risk factor associated with painful colonoscopy rate
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
Study officials:
References:
Clinical trial NCT05604612: Assessment of the Effectiveness of Corticision Combined by Selfligating Bracket System on the Acceleration of Orthodontic Tooth Movement; A Prospective Clinical Study
Official title: Assessment of the Effectiveness of Corticision Combined by Selfligating Bracket System on the Acceleration of Orthodontic Tooth Movement; A Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the goal of this clinical trial is to assess the effectiveness of the corticision with self-ligating bracket system on the acceleration of orthodontic tooth movement.The main question it aims to answer is whether or not there would be an augmented effect by undergoing corticision with using self-ligating brackets regarding the acceleration of orthodontic tooth movement.


Eligibility criteria: Inclusion Criteria:

* Class I orthodontic patients with mild to moderate crowding of upper anterior segment (2-4 mm) All permanent teeth are erupted (3rd molar not included). Good oral and general health No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement No previous orthodontic treatment.

Exclusion Criteria:

* Orthodontic cases with severe crowding of upper anterior segment that require extraction treatment approach. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment. Patients with untreated decay or endodontic lesion.

Primary outcomes:
measure: Little's Irregularity Index
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: