louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03021265: To Evaluate Real-world Safety, Effectiveness and Appropriate Use of Micatrio® Combination Tablets Treatment in Patients With Hypertension
Official title: The Special Drug Use-results Survey on Long-term Use of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed Dose Combination Tablets in Patients With Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 676
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500

Brief summary: Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension

Detailed description: Non-interventional study based on newly collected data. The study will consist of a baseline visit and follow-up visits at Week 4, 8, 12, 24, 36 and 52 for patients who have newly initiated Micatrio® Combination Tablets. The patients will be followed up until discontinuation of Micatrio® Combination Tablets treatment or the end of study.

All patients administrated Micatrio® Combination Tablets after the launch at the sites contracted with the sponsor will be registered.

Eligibility criteria: Inclusion criteria:

* Patients who are prescribed with Micatrio® Combination Tablets by the discretion of investigators based on the Japanese package insert
* Patients who have never been treated with Micatrio® Combination Tablets before enrolment

Exclusion criteria:

Patients who are participating/planned to participate in a clinical trial

Primary outcomes:
measure: Frequency of Patients With Any Suspected Adverse Drug Reactions
timeFrame: from first intake of Micatrio combination tablet until last intake +1 day (week 52)
Secondary outcomes:
measure: Change From Baseline in Clinic Diastolic Blood Pressure at Week 52
timeFrame: At baseline and week 52
measure: Change From Baseline in Clinic Systolic Blood Pressure at Week 52
timeFrame: At baseline and week 52
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
affiliation: zzCDMJP_PV_PMS@boehringer-ingelheim.com
name: Rie Ikeda, +81364172200
role: STUDY_CHAIR
References:
Clinical trial NCT01480765: Preventing Pain After Heart Surgery
Official title: Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Hyperalgesia
Chronic Illness
Neuropathic Pain
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery


Eligibility criteria: Inclusion Criteria:

* Informed Consent
* First time sternotomy for all cardiac surgery
* Patient aged 18 - 80 years

Exclusion Criteria:

* Emergency surgery (decision to operate taken on the day of surgery)
* Previous sternotomy
* Preoperative renal failure (eGFR \<60 ml/min)
* History of chronic non-anginal pain
* Chronic pain medication other than paracetamol and non-steroidal anti-inflammatory drugs
* Concurrent use of oxycodone, lorazepam, or ethanol.
* Concurrent use of any drugs for neuropathic pain e.g. antiepileptics, antidepressants
* Allergy to pregabalin, gabapentin or ketamine
* Pregnancy
* Limited understanding of numerical scoring scales
* Previous participation in other trials investigating analgesic agents or any IMP in previous three months

Primary outcomes:
measure: Numerical Rating Scale (NRS) pain score (around sternotomy incision site) post surgery, at rest and following 3 maximal coughs.
timeFrame: 3 and 6 months post sternotomy
Secondary outcomes:
measure: Total morphine consumption at 24 hours post surgery
timeFrame: 24 hours post surgery
measure: Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs
timeFrame: 24 hours post surgery
measure: Sedation (including pCO2) and nausea scores at 24 hours post surgery
timeFrame: 24 hours post surgery
measure: Side effect episodes (dizziness, confusion, blurred vision)
timeFrame: First 48 hours
measure: Time to extubation
timeFrame: Post op recovery period
measure: Length of stay in intensive care and hospital
timeFrame: Post operative - acute
measure: 28 day mortality
timeFrame: 28 days post surgery
measure: Neuropathic pain score
timeFrame: 3 and 6 months post surgery
measure: Quality of Life
timeFrame: 3 and 6 months
measure: Survival
timeFrame: 3 and 6 months
measure: QST measurements
timeFrame: Pre op and post op at 72hrs and 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Pain and Ananesthesia Research Centre, Barts and The London NHS Trust
Study officials:
affiliation: Barts and The London NHS Trust
name: Sibtain Anwar, MA MB FRCA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03677765: Comparisons of Complications Related to Two Approaches of Ultrasonography-guided Subclavian Venous Catheterization
Official title: A Prospective Non-inferiority Trial on Complications Related to Ultrasonography-guided Subclavian Venous Catheterization: Supraclavicular Versus Infraclavicular Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication of Treatment
Catheterization
Keywords: subclavian venous catheterization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 416
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For performing subclavian venous catheterization, two approaches (supraclavicular and infraclavicular) have been used successfully in various clinical practice. However, there remains controversy concerning which approach is safer and causes less complications during ultrasonography-guided subclavian venous catheterization. In this context, the investigators sought to compare supraclavicular approach with infraclavicular approach in terms of post-procedural complications during ultrasonography-guided subclavian venous catheterization.


Eligibility criteria: Inclusion Criteria:

* patients who require subclavian venous catheterization
* adult patients aged 20-79

Exclusion Criteria:

* patient's refusal
* patients with contraindication of subclavian venous catheterization (skin infection at puncture site, tumor or thrombus in the course of subclavian vein, vegetation at tricuspid valve, patients on anticoagulation)
* patients with chemoport or pacemaker in subclavian vein
* patients with right-sided breast cancer operation or with right-sided pneumonectomy

Primary outcomes:
measure: the overall incidence of complications
timeFrame: intraoperatively to 1 hour after the admission of ICU
Secondary outcomes:
measure: the first-pass success rate
timeFrame: intraoperatively
measure: the number of needling for venipuncture
timeFrame: intraoperatively
measure: Total time for venipuncture
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee-pyoung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YJ, Ma S, Yoon HK, Lee HC, Park HP, Oh H. Supraclavicular versus infraclavicular approach for ultrasound-guided right subclavian venous catheterisation: a randomised controlled non-inferiority trial. Anaesthesia. 2022 Jan;77(1):59-65. doi: 10.1111/anae.15525. Epub 2021 Jul 6.
Clinical trial NCT02667665: Verification Study and Reactivity Study for the Validity of QuQu Scale
Official title: Verification Study and Reactivity Study for the Validity of a Novel Dementia Rating Scale "QUick QUestion Scale" for Alzheimer's Disease Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease Dementia
Cognitive Concern Without Dementia
Keywords: Alzheimer's Disease Dementia
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo Co., Ltd.
First posted: 2016-01-29
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment

Brief summary: Examine the construct validity, the test-retest reliability, the concurrent validity with the standard dementia rating scales and the reactivity of a novel dementia rating scale "QuQu scale: QUick QUestion scale" final for the evaluation of patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment.


Eligibility criteria: Inclusion Criteria:

1. Alzheimer's Disease Dementia and patients with cognitive concern without Dementia
2. Written Informed consent by each subject and/or a legal representative, and study informant. If the doctor decides that the patient has no trouble in understanding this study, the written informed consent of a legal representative may be exempted. If not, this study needs a written informed consent by a legal representative and the patient except the case where the consent is hardly obtained due to the progression of the disease.

Exclusion Criteria:

1. patients with other types of dementia (e.g. vascular dementia, Levy body dementia, frontotemporal dementia)
2. patients with other diseases which cause secondary dementia prior to Alzheimer's Disease Dementia
3. patients with other severe neurological disease or psychiatric disorder without Alzheimer's Disease Dementia
4. patients with other medical conditions where the investigators determine that it is inappropriate for the subject of this study (e.g. inappropriate for the evaluation of dementia rating scale)

Primary outcomes:
measure: QuQu scale candidate
timeFrame: 12 weeks
measure: Mini-Mental State Examination (MMSE)
timeFrame: 12 weeks
measure: NPI-Caregiver Distress. Scale(NPI-D)
timeFrame: 12 weeks
measure: Disability Assessment for Dementia (DAD)
timeFrame: 12 weeks
measure: Clinical Dementia Rating
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kitagun
country: Japan
facility: Kagawa University School of Medicine
state: Kagawa Prefecture
Study officials:
affiliation: Kagawa University School of Medicine
name: Yu Nakamura, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06048965: Asia Pacific Menopause Federation Menopause Consensus
Official title: An Expert Panel Consensus Statement on the Management of Menopause in the Asia-Pacific Using Modified Delphi Methodology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Menopause
Menopause Related Conditions
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians with experience in treating menopause

Brief summary: The aim of this study is to achieve expert consensus on the management of menopause in the Asia-Pacific

Detailed description: The aim of this study is to achieve expert consensus on the management of menopause in the Asia-Pacific. The experience of the menopause is deeply rooted in sociocultural perceptions unique to each population. Thus, the management of menopausal symptoms and other conditions related to the menopause also vary from region to region.

The investigators will use a modified Delphi method involving the participation of experts from various countries in the Asia-Pacific. The objective of this study is to achieve consensus on various aspects of the management of the menopause in the Asia-Pacific.

This study will involve several rounds of Delphi surveys, administered via Google Forms, Microsoft Word or PDF. Each survey questionnaire contains

1. Questions on basic demographic information
2. Statements on areas of concern in the management of the menopause; each participants vote on to what extent they agree or disagree with the statement on a Likert scale.
3. Questions on the participants' usual clinical practice in treating menopause Multiple survey rounds will be held until agreement on the statements and stability is achieved.

Eligibility criteria: Inclusion Criteria:

Experience in treating menopause

Primary outcomes:
measure: Percentage of participants who vote for the same option on a series of survey questions
timeFrame: 2023-2024
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
Clinical trial NCT01235065: GlideScope Versus Direct Laryngoscope for Emergency Intubation
Official title: GlideScope vs. Direct Laryngoscope for Emergency Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Intubation
Keywords: airway management
trauma
intubation
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 623
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 study is to assess if the GlideScope video laryngoscope is superior to the Macintosh direct laryngoscope for definitive airway management in acutely-injured patients.

Detailed description: On admission to the emergency department following traumatic injury, many patients require placement of an artificial airway to support their breathing, provide oxygen and protect their airway. This procedure is accomplished through a number of different techniques and few studies have compared these techniques in order to establish the best method. We will compare an older technique using a metal handle and blade that allows for direct visualization of the vocal cords (direct laryngoscopy) to a newer technique that employs a fiberoptic bundle imbedded in a handle that allows indirect visualization of the vocal cords during placement of the artificial airway. The newer technique has the theoretical advantage of being more useful in patients with abnormal airways which are frequently encountered in trauma patients. Since both techniques are currently employed routinely in our institution, we will randomize all trauma admission to have an initial attempt with one of the two techniques in order to perform a randomized, unblinded trial.

Eligibility criteria: Inclusion Criteria:

* require emergency intubation

Exclusion Criteria:

* age \< 18
* require surgical airway on initial assessment
* have known or strongly suspected spinal cord injury

Primary outcomes:
measure: Number of Participants Who Survived to Hospital Discharge
timeFrame: 2 weeks, on average
Secondary outcomes:
measure: Length of Time to Perform the Intubation Procedure
timeFrame: Up to 100 seconds
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: R Adams Cowley Shock Trauma Center
state: Maryland
Study officials:
affiliation: University of Maryland
name: Dale Yeatts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02137057: The Effect of Spinal Anesthesia on Heart Rate Variability in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rate Variability
Diabetes
Spinal Anesthesia
Keywords: Heart Rate Variability
spinal anesthesia
DM
cardiac autonomic dysfunction
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing lower limb surgery with spinal anesthesia

Brief summary: Cardiac autonomic neuropathy is a common complication of diabetes and is associated with resting tachycardia. Regional anesthesia could interrupt normal autonomic activity by central sympathetic blockade. The investigators evaluate the relation of severity of diabetes and heart rate variability, also the impact of spinal anesthesia on the change of heart rate variability.


Eligibility criteria: Inclusion Criteria:

* patients undergoing lower limb surgery with spinal anesthesia (ASA class 1,2,3)

Exclusion Criteria:

* severe coagulopathy, short height, arrhythmia patients, patients taken medication which could affect autonomic nervus system (bata- blocker or alpha-blocker)

Primary outcomes:
measure: Change of Heart rate variability during spinal anesthesia : total power, power of LF and HF, and LF/HF ratio
timeFrame: 10 min before spinal anesthesia (T0: Baseline ) 10 min (T1), 20 min (T2) and 30 min (T3) after spinal injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
citation: Lee SH, Lee DH, Ha DH, Oh YJ. Dynamics of heart rate variability in patients with type 2 diabetes mellitus during spinal anaesthesia: prospective observational study. BMC Anesthesiol. 2015 Oct 8;15:141. doi: 10.1186/s12871-015-0125-6.
Clinical trial NCT02995057: Safety Demonstration of Microneedle Insertion
Official title: Safety Demonstration of Microneedle Insertion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Reaction to Nickel
Keywords: Microneedles
Biocompatibility
Allergy
Metal
Nickel
Contact dermatitis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2016-12-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 15 subjects will be enrolled in the trial. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be eligible to enroll in the trial.

Brief summary: Hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of humans and animals. Side effects of these needle injections are pain, bleeding, and anxiety in patients. An alternative drug and vaccine delivery method is the use of hollow microneedles, which are sub-millimeter needle-like structures. Microneedles are pain- and bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. As a result, they are better received by patients and do not induce needle anxiety. As the investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel, the purpose of this study is to observe their biocompatibility and inertness.


Eligibility criteria: Inclusion Criteria:

* Proven nickel allergy

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Skin reaction as measured by a contact dermatitis classification system
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: Professor
name: Urs Hafeli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05130957: The Effect of Clove Oil on Labor Pain
Official title: The Effect of Massage Applied With Clove Oil on Perceived Labor Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: labor pain
midwifery
pregnant women
massage
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups as experimental and control.
Primary purpose: TREATMENT

Brief summary: The study has two groups. one of them is experimental group that is given massage with clove oil. The other one is control group that is given standard midwifery care. Each group consists of 30 women. We will evaluate their labor pain scores by using Visual Analogue Scale before and after massage application.

Detailed description: Labor is a painful process. That's why there are lots of nonpharmacological methods to reduce labor pain. Especially most clinical guide suggests giving massage to pregnant who has labor pain. In the literature, there are a lot of study examining effectiveness of massage techniques. However there is no study about massage application with clove oil on labor pain. The investigators would like to give a massage with clove oil to pregnants to reduce their labor pain. Hereby the investigators will evaluate effectiveness of clove oil.

Eligibility criteria: Inclusion Criteria:

* All of volunteer and pregnant women is 18-35 years old.

Exclusion Criteria:

* The pregnant women has any obstetrical complications.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: during labor process, until the labor process is done.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital- Maternity Hospital
state: Çankaya
Study officials:
affiliation: Ankara City Hospital- Maternity Hospital
name: Nükhet Kaçar, MSc.
role: PRINCIPAL_INVESTIGATOR
References: