louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02748876: Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
Official title: A Randomised Cross-over Pilot Study of the Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2016-04-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cardiac resynchronisation therapy (CRT) is a specialised type of pacemaker used in patients with severe heart failure to improve symptoms and survival. Approximately one third of patients treated with CRT do not notice significant improvement in their symptoms and this may be due to inadequate co-ordination between the upper and lower chambers of the heart (atrioventricular dyssynchrony).

The investigators propose a new method to achieve atrioventricular synchrony in CRT based on measurements of electrical conduction from within the heart. Patients referred for CRT implantation at Castle Hill Hospital are eligible to participate. During CRT implantation, additional measurements, will be recorded from within the heart. After implantation, device settings will be adjusted to either standard or electrophysiologically-optimised settings with cross-over at 4 months.

The investigators hypothesis is that patients with optimised settings will derive additional benefit compared to patients with standard pacemaker-determined settings.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of heart failure
* Referred for cardiac resynchronisation therapy (CRT) with or without defibrillator
* In sinus rhythm
* Patients must have a telephone
* Ability to give informed consent
* Ability to complete the study

Exclusion Criteria:

* Severe valve disease or previous valve replacement
* Previous atrial flutter ablation
* Chronic kidney disease Stage 3 or above
* Recent myocardial infarction
* Ongoing cardiac ischaemia
* Infiltrative cardiomyopathy
* Wolff-Parkinson White syndrome
* Presence of second or third degree heart block
* \<90% biventricular pacing at 3 months
* Hypertrophic cardiomyopathy
* Pregnancy or breastfeeding
* On treatment for hypothyroidism or hyperthyroidism

Primary outcomes:
measure: Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)
timeFrame: 7 months and 11 months
Secondary outcomes:
measure: Increase in 6-min walk test distance by ≥25 m
timeFrame: 7 months and 11 months
measure: ≥5points improvement in the short Kansas City Cardiomyopathy Questionnaire score
timeFrame: 7 months and 11 months
measure: Reduction of left ventricular end-diastolic volume.
timeFrame: 7 months and 11 months
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
Study officials:
References:
Clinical trial NCT04848376: Post-Market Clinical Follow-up Study of A-SPINE's Products
Official title: Post-Market Clinical Follow-up Study of A-SPINE's Products
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Disc Disease
Kyphosis
Scoliosis
Trauma
Tumor
Stenosis
Pseudoarthrosis of Spine
Deformity
Lead sponsor: A-Spine Asia Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 200
Sex: ALL
Minimum age (years): 20
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: The patients have implanted an A-SPINE device to stabilize the spine and/or restore the height of disc.

Brief summary: This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before and after surgery.

Detailed description: The purpose of study is to confirm the safety and and performance of the A-SPINE's products for using 2 years. This post-market clinical follow-up study use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to evaluate the clinical improvement effects. Subjects will be evaluated at pre-operation, 6 months, 12 months, and 2 years post treatment. Finally, analyze the clinical outcome, fusion rate, and adverse events.

Eligibility criteria: Inclusion Criteria:

* Subject is above 20 years of age;
* Subject is indicated for A-SPINE Spinal Fixation System;
* Subject is willing and able to provide informed consent to participate in the study;
* Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits.

Exclusion Criteria:

* Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion Criteria.

Primary outcomes:
measure: Visual Analogue Scale- Change from baseline at 2 year
timeFrame: Change from baseline at 2 year
Secondary outcomes:
measure: Neck Disability Index
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Oswestry Disability Index
timeFrame: Baseline, 6 months,12 months, 24 months
measure: Number of Device-related Adverse Events
timeFrame: Baseline, 6 months,12 months, 24 months
measure: Fusion Rate
timeFrame: Baseline, 6 months,12 months, 24 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Tzu Chi Hospital
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Bryan Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00896376: Trastuzumab in Treating Women With Metastatic Breast Cancer
Official title: Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: stage IV breast cancer
HER2-positive breast cancer
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2009-05-11
Enrollment: 49
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: RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer.

Detailed description: OBJECTIVES:

Primary

* To evaluate the predictive value of genetic factors on the toxicity and efficacy of a trastuzumab-based therapy in women with metastatic breast cancer.

Secondary

* To analyze tumor factors potentially related to the efficacy of trastuzumab (i.e., expression of proteins involved in cell proliferation and survival).

OUTLINE: This is a multicenter study.

Patients receive standard treatment with trastuzumab. Blood is collected periodically for pharmacogenetic analysis.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer

  * Metastatic disease, defined by the existence of a secondary tumor localization radiologically (i.e., by radiography, CT scan, MRI scan, or ultrasound) or scintigraphically confrimed
* Evaluable disease
* Beginning first-line metastatic treatment with trastuzumab (Herceptin®) with or without chemotherapy
* Primary tumor must overexpress HER2 (IHC 3+ OR IHC 2+ and FISH+ OR FISH+)
* Hormone receptor status not specified
* No brain metastasis

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Life expectancy \> 3 months
* Able to undergo cardiotoxicity evaluation every 4 months by measuring LVEF via an isotopic method or ultrasound with systematic registration
* No chronic uncontrolled disease
* No heart failure
* No respiratory failure or hypoxemia
* No history of another primary cancer except for basal cell carcinoma of the skin
* No severe uncontrolled infection
* No psychological incapacity

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Toxicity, including cardiotoxicity and immuno-allergic reactions
timeFrame: 1 year
measure: Clinical response as assessed by RECIST criteria
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
affiliation: Centre Antoine Lacassagne
name: Jean Marc Ferrero, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04018976: AVACEN Treatment Method and Postprandial Blood Glucose
Official title: AVACEN Treatment Method and Postprandial Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN device on postprandial blood glucose. The AVACEN device creates negative pressure around the hand while heating the palm. Two sham devices, one providing heat but no vacuum and one providing neither heat nor vacuum were also used. Each subject will use each of these three devices during the first hour of a 2-hour oral glucose tolerance test on separate visits. Subjects arrived in the morning following an overnight fast. Fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal ratings were measured before and throughout the 2-hour oral glucose tolerance test.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Diagnosis of diabetes, diabetes medication, hypertension medication

Primary outcomes:
measure: Postprandial Blood Glucose
timeFrame: 30 minutes
Secondary outcomes:
measure: Blood Pressure
timeFrame: 30 minutes
measure: Tympanic Temperature
timeFrame: 30 minutes
measure: ASHRAE 7 point thermal sensation scale
timeFrame: 30 minutes
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Jeff Moore
state: California
Study officials:
affiliation: San Diego State University
name: Jeff M Moore, B.S./B.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05517876: A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C
Official title: A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Vascular Surgery
Peripheral Vascular Surgery
Vascular Prothesis
Aneurysm Abdominal
Aneurysm; Peripheral
Obliterative Arterail Disease
Lead sponsor: Perouse Medical
Sponsor class: INDUSTRY
Collaborators: name: Eclevar Medtech
First posted: 2022-08-26
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All potential subjects and will select those who are appropriate for study inclusion, i.e. subjects implanted with POLYMAILLE® C for at least one year, or with complete data to death. As the study explores real world data, there is no exclusion criteria for subjects and all subjects with POLYMAILLE® C implanted for at least one year and up to 5 years will be included in the study.

All data will be retrieved from medical charts for each patient from time of surgery (considered as index date) until a maximum of 5 years after surgery.

A minimum of 100 subjects will be evaluated for each main location of surgery (peripheral and abdominal).

Brief summary: Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and peripheral).

Follow-up At least 1 year follow-up after surgery until a maximum of 5 years. POLYMAILLE®C vascular prostheses are indicated for replacement or bypass of arteries presenting aneurysm or obliterative arterial disease. Their indication is restricted to abdominal and peripheral surgery not crossing the knee flexion crease.


Eligibility criteria: Inclusion Criteria:

* Patients must meet all the following inclusion criteria in order to be eligible for inclusion in the study: Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death

Exclusion Criteria:

* Patients who have objected to the collect of their data.

Primary outcomes:
measure: Primary performance endpoint
timeFrame: 1 year
measure: Primary safety endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Procedural success rate
timeFrame: 5 years
measure: Primary patency rate
timeFrame: 5 years
measure: Primary assisted patency rate
timeFrame: 5 years
measure: Secondary patency rate
timeFrame: 5 years
measure: Device Failure
timeFrame: 5 years
measure: Mortality rate
timeFrame: 5 years
measure: Limb salvage rate
timeFrame: 5 years
measure: Adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes'
Study officials:
References:
Clinical trial NCT01565876: Auxiliary Device to Alleviate Soldiers' Backload
Official title: Auxiliary Device to Alleviate Soldiers' Backload
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physiological Strain of Weight Bearing.
Keywords: weight bearing
physiological load
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 12
Sex: MALE
Minimum age (years): 21
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Combat soldiers are required to perform under strenuous physical conditions; hence, their physical fitness is a crucial factor in their survivability.

The Auxiliary Device- "Minkal", is suggested (by its manufactures) to be able to reduce the soldiers' physiological strain by lowering the absolute load being carried by the soldier. As a result, it may improve the soldier's physiological abilities and performance through enduring missions with heavy loads, and may lead to better protection on the soldier from overuse injuries.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects without any of the following: chronic background diseases, cardiovascular, lung or respiratory, heat stroke history, headaches,psychiatric background, musculoskeletal problems, and without drugs use.
* Lack of any acute disease during 2 weeks prior the study.
* Subjects will give their written consent for participating the study after being informed by the study's physician about the study's aims, importance and the possible risks.

Exclusion Criteria:

* Rectal temperature above 39 Celsius degrees.
* HR above maximal HR ( calculated as 220-age)
* The subject's will to stop the test.
* The researcher's/doctor's judgment.

Primary outcomes:
measure: Physiological Load with and without the auxiliary device
timeFrame: 6 days for each patient.
Secondary outcomes:
measure: Rectal temperature
timeFrame: 6 days
measure: Skin temperature
timeFrame: 6 days
measure: Heart Rate
timeFrame: 6 days
measure: Sweat Rate
timeFrame: 6 days
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Institute of military physiology
Study officials:
affiliation: Institute physician
name: Chen Makernatz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of the military physiology institute, IDF medical corps
name: Yuval Heled, PhD
role: STUDY_DIRECTOR
affiliation: The director's deputy of the military physiology institute, IDF medical corps
name: Ran Yanovich, MA
role: STUDY_DIRECTOR
References:
Clinical trial NCT06284876: Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Official title: A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Peptic Ulcer
Lead sponsor: Il-Yang Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 416
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24

Detailed description: Not provided

Eligibility criteria: Inclusion Criteria:

1. Adult males and females aged 19 years or older on the day of informed consent
2. Subjects requiring continuous treatment or receiving treatment with NSAIDs
3. Subjects with at least one of following peptic ulcer risk factors at the time of Screening
4. Subjects who have provided voluntary informed consent for the study participation after the study is explained

Exclusion Criteria:

1. Subjects with Gastroesophageal varices, Esophageal stricture or ulcerous stenosis, Gastrointestinal bleeding or perforation, Esophageal dysplasia and else based on the screening EGD results.
2. Subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder
3. Subjects with confirmed history of malignancy within 5 years prior to Screening
4. Positive human immunodeficiency virus (HIV) antigen/antibody at Screening

Primary outcomes:
measure: Ilaprazole, Lansoprazole peptic ulcer
timeFrame: at 24 weeks
Secondary outcomes:
measure: Ilaprazole, Lansoprazole peptic ulcer
timeFrame: at 12 weeks
measure: Ilaprazole, Lansoprazole GI bleeding
timeFrame: at 12, 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Chung-Ang University Hospital Center
name: JungSoo Song, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04828876: The Effect of Yoga on Sleep and Quality of Life in Epilepsy Patients
Official title: The Effect of Yoga on Sleep and Quality of Life in Epilepsy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: yoga
Sleep
Quality life
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental study with pre-test and post-test control groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determining the sleep quality and quality of life of epilepsy patients and offering solutions can be effective in their success both in their professional and social lives.

Therefore, in this study, it was aimed to evaluate the effectiveness of yoga therapy on sleep quality and quality of life in epilepsy patients.

Detailed description: Yoga is an ancient Hindu practice with documented therapeutic effect in western countries and means perfect control of the body, emotions and mind. It consists of breathing exercises, asanas (posture), relaxation and meditation exercises. Through breathing exercises, various postures, and meditation in yoga, the connection between mind and body is established and a balanced health is assisted.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with epilepsy for at least six months,
* Does not have any disease that causes insomnia and does not use sleeping pills
* Have not participated in a similar regular exercise program in the last 6 months,
* Seizures are under control,
* Do not have a physical illness or cognitive deficiency and a psychiatric disease that prevents understanding of the education given

Exclusion Criteria:

* Epilepsy patients who do not agree to participate in the study

Primary outcomes:
measure: Quality of Life Scale in Epilepsy
timeFrame: 1. week
measure: Quality of Life Scale in Epilepsy
timeFrame: 6. week
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 1. week
measure: Pittsburgh Sleep Quality Index
timeFrame: 6. week
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Sabahattin Zaim University
name: Zülfünaz ÖZER, PhD
role: STUDY_CHAIR
References:
citation: Ozer Z, Bahcecioglu Turan G, Aksoy M. The effects of yoga on dyspnea, sleep and fatigue in chronic respiratory diseases. Complement Ther Clin Pract. 2021 May;43:101306. doi: 10.1016/j.ctcp.2021.101306. Epub 2021 Jan 19.
citation: Amaravathi E, Ramarao NH, Raghuram N, Pradhan B. Yoga-Based Postoperative Cardiac Rehabilitation Program for Improving Quality of Life and Stress Levels: Fifth-Year Follow-up through a Randomized Controlled Trial. Int J Yoga. 2018 Jan-Apr;11(1):44-52. doi: 10.4103/ijoy.IJOY_57_16.
Clinical trial NCT04159376: Assessment of the Accuracy of PET/MR in Detection and Monitoring Response of Bone Metastases
Official title: Assessment of the Accuracy of PET/MR in Detection and Monitoring Response of Bone Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Metastases
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-11-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The great promise of PET/MR for assessment of skeletal metastatic involvement is derived from the extensive experience with stand- alone MR, but initial data on the use of PET/MR for assessment of bone pathology indicate that PET/MR introduces unique issues that should be addressed when determining its role in this clinical scenario.

In this study cohort includes 150 patients 18 years or older, having metastatic skeletal involvement on baseline PET/CT prior to treatment. Baseline studies and follow up studies of the patients referred post treatment, will be reviewed.

The main goal of the study is to asses the accuracy of PET/MR in detection and monitoring response of bone metastases.


Eligibility criteria: Inclusion Criteria:

150 patients having metastatic skeletal involvement on baseline PET/CT prior to treatment

Exclusion Criteria:

1. Age \<18.
2. Pregnant or breast feeding patients.

Primary outcomes:
measure: The investigators will report about the number of patients who preformed PET/MR for assessment of skeletal involvement as well as activity after treatment,
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: