louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00520832: A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys
Official title: A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Insomnia
Keywords: Primary Insomnia
Microcurrent Therapy
Sleep Surveys
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2007-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Participants identified as having primary insomnia will be randomly assigned to groups receiving microcurrent stimulation or sham in a double-blind randomized controlled trial. The microcurrent device used is FDA approved for the treatment of insomnia.

The hypothesis is that the experimental group will have significantly improved scores on three sleep surveys after treatment while the sham group will not.


Eligibility criteria: Inclusion Criteria:

* Student, Faculty or Staff
* Age 18 - 40
* Symptoms of primary insomnia

Exclusion Criteria:

* No implanted electric devices
* No local infection, injury or malignancy
* No history of seizure or other neurological disorders
* No current use of prescription or other substances that could effect sleep quality or quantity
* Pregnancy

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
measure: Epworth Sleepiness Scale
measure: Insomnia Severity Index
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
affiliation: Logan College of Chiropractic
name: Rodger Tepe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03545932: Self-perception of Health Status and Physical Condition of Elderly People Practitioners of Hydrogymnastics
Official title: Self-perception of Health Status and Physical Condition of Elderly People Practitioners of Hydrogymnastics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Keywords: Hydrogymnastics
Physical Condition
Physical Activity and Health
Gerontomotricity
Lead sponsor: Instituto Politécnico de Castelo Branco
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 83
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The researcher interest in self-perception of health status and physical condition of the elderly is determinant in an increasingly aging society and where one should seek to improve their quality of life.

Detailed description: Introduction: The researcher interest in self-perception of health status and physical condition of the elderly is determinant in an increasingly aging society and where one should seek to improve their quality of life.

Objective: To study the self-perception of health status and the impact of a physical activity program oriented during 4 months in an elderly population practitioners of hydrogymnastics.

Methods: As instruments were used the questionnaire mos short health survey - 36 items version 2 (SF-36), and the battery of Functional Tests Fitness Test. The questionnaires were filled by the elderly with the presence of the investigator and the physical fitness was evaluated following the protocol of proof. The sample was constituted of 83 elderly individuals over 55 years of age. In statistical terms we used a percentage analysis in the questionnaire and in the evaluation of the physical condition after application of the Kolmogorov-Smirnov test, we used the non-parametric test for two paired variables Wilcoxon.

Eligibility criteria: Inclusion Criteria:

* hydrogymnastics practitioners
* participants over 55 years of age

Exclusion Criteria:

-

Primary outcomes:
measure: Self-perception of health status
timeFrame: 1 month
Secondary outcomes:
measure: Muscle strength - Legs
timeFrame: 1 month
measure: Muscle strength - Arms
timeFrame: 1 month
measure: Flexibility - Legs
timeFrame: 1 month
measure: Flexibility - Arms
timeFrame: 1 month
measure: Dynamic balance
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04307732: Impact of Preoperative Nutritional Status on the Postoperative Mortality and Morbidity in Patients Undergoing Valvular Heart Surgery
Official title: Impact of Preoperative Nutritional Status on the Postoperative Mortality and Morbidity in Patients Undergoing Valvular Heart Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Undergoing Valvular Heart Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Terticary care hospital

Brief summary: The investigators investigated the clinical impacts of preoperative nutritional status on mortality in patients undergoing valvular heart surgery. Preoperative nutritional status was evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score. The primary outcome was the association between preoperative nutritional status evaluated by PNI, GNRI, and CONUT score and postoperative mortality. The predictive discrimination ability for mortality between PNI, GNRI, and CONUT were compared. Risk factors for mortality were identified.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent valvular heart surgery from January 2013 to February 2018

Exclusion Criteria:

* Patients younger than 18 years
* Patients undergoing combined congenital heart surgery
* Patients undergoing transcatheter valve replacement

Primary outcomes:
measure: postoperative mortality according to peroperative nutritional status
timeFrame: 1 year after surgery
measure: postoperative mortality according to peroperative nutritional status
timeFrame: 2 year after surgery
Secondary outcomes:
measure: predictive discrimination ability for mortality between PNI, GNRI, and CONUT
timeFrame: 1 year after surgery
measure: predictive discrimination ability for mortality between PNI, GNRI, and CONUT
timeFrame: 2 year after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Cho JS, Shim JK, Kim KS, Lee S, Kwak YL. Impact of preoperative nutritional scores on 1-year postoperative mortality in patients undergoing valvular heart surgery. J Thorac Cardiovasc Surg. 2022 Oct;164(4):1140-1149.e3. doi: 10.1016/j.jtcvs.2020.12.099. Epub 2021 Jan 5.
Clinical trial NCT02646332: Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy
Official title: Comparing the Efficacy and Impact on Gastrointestinal Microbiota of Reverse Hybrid Therapy and Concomitant Therapy in Helicobacter Pylori Eradication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Eradication rate
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 248
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.

Detailed description: A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.

Eligibility criteria: Inclusion Criteria:

* Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

* previous H pylori-eradication therapy
* ingestion of antibiotics or bismuth within the prior 4 weeks
* patients with allergic history to the medications used
* patients with previous gastric surgery
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
* pregnant women

Primary outcomes:
measure: Number of Participants in Which H. Pylori Was Eradicated
timeFrame: sixth week after the end of anti- H. pylori therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Ping-I Hsu, Bachelor
role: STUDY_CHAIR
References:
Clinical trial NCT06330532: Impact of Preoperative Frailty and Cognitive Impairment on Postoperative Outcomes in Elderly Cardiac Surgery Patients
Official title: Impact of Preoperative Frailty and Cognitive Impairment on Postoperative Outcomes in Elderly Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 447
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age 65 and older undergoing heart and aortic surgery

Brief summary: This is a retrospective study of patients aged 65 years and older who underwent cardiac and aortic surgery between March 5, 2021 and October 12, 2022 in the operating room of Severance Cardiovascular Hospital to determine the impact of physical frailty as well as nutritional status, emotional dysregulation, and cognitive dysfunction on postoperative outcomes. Physical frailty will be determined by the Clinical Frailty Scale, handgrip strength, and nutritional status, cognitive dysfunction will be determined by the K-MMSE and K-MoCA administered at the preoperative interview, and emotional dysregulation will be determined using the SGDS-K. These were measured during the pre-anesthesia evaluation and only results from patients who agreed to be tested will be used. Nutritional status will be analyzed based on blood test values measured within one month of surgery.


Eligibility criteria: Inclusion Criteria:

* 65-year-old patients undergoing surgery for heart and aortic disease, who completed physical (Clinical Frailty scale, Handgrip strength), cognitive(K-MoCA, K-MMSE), and emotional (SGDS-K) functioning tests at the preoperative interview

Exclusion Criteria:

* Failed to complete two or more of assessments shown above

Primary outcomes:
measure: postoperative all cause mortality
timeFrame: within 1 year
measure: major composite morbidity
timeFrame: within 30days after surgery for major composite morbidity
Secondary outcomes:
measure: the number of days not in hospital
timeFrame: 90 days
measure: The number of participants who die
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health system, Severance Hospital
Study officials:
References:
Clinical trial NCT00448032: Study Evaluating Multiple Oral Doses of PPM-204 in Healthy Japanese Male Subjects
Official title: A Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Ppm-204 Administered Orally to Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-15
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A study evaluating the safety and pharmacokinetics of multiple oral doses of an investigational oral diabetic agent when given to healthy Japanese male volunteers.


Eligibility criteria: Inclusion Criteria:

* Men, aged 20 to 45 years, inclusive
* Body mass index in the range of 17.6 to 26.4 kg/m2
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)

Exclusion Criteria:

* History of cardiac, thyroid, muscle, and kidney abnormalities
* History of NSAID induced bronchospasm or asthma
* History of any clinically important allergies

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: Pharmacokinetics/Pharmacodynamics
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02919332: Delayed 18F-FDG PET/CT in Improving Visualization of Brain Tumors in Patients With Glioblastoma
Official title: Improved Visualization of Glioblastoma Using Delayed 18F-FDG PET/CT.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Glioblastoma
Glioma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years of age who have been diagnosed with a brain tumor and are undergoing a PET/CT scan..

Brief summary: This clinical trial studies how well delayed fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) works in improving visualization of brain tumors in patients with glioblastoma. Radiotracers such as 18F-FDG are highly taken up by tumors in the brain and are visualized using PET/CT. Increasing the interval of time between 18F-FDG administration and PET/CT scan may improve the visualization of brain tumors in patients with glioblastoma.

Detailed description: PRIMARY OBJECTIVES:

I. To improve the visualization/delineation of glioblastoma lesions using delayed 18F-FDG PET/CT imaging.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV). Patients then undergo a standard of care PET/CT scan at 60 minutes and a second PET/CT scan at 240 minutes after injection.

Note:

Standard Uptake Value (SUV) is defined for state-of-the art PET/CT scanners as Standardized uptake values = count activity per ml within region of interest (MBq/ml)/\[injected dose (MBq)/body weight (kgx1000)\]

Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven high grade glioma scheduled for 18F-FDG PET/CT

Exclusion Criteria:

* Severe psychiatric illness
* Inability to give written consent
* Breast feeding/pregnancy

Primary outcomes:
measure: Tumor-to-background ratio on delayed scans (240 min after injection)
timeFrame: Baseline up to 240 minutes after injection
measure: Tumor-to-background ratio on standard scans (60 min after injection)
timeFrame: Baseline up to 60 minutes after injection
Secondary outcomes:
measure: Standard uptake value comparison
timeFrame: 240 minutes post injection
measure: Standard uptake value comparison
timeFrame: 60 minutes post injection
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Johannes Czernin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06169332: Multidetector CT Left Appendage Atrial Thrombosis Exclusion in Patients With Atrial Fibrillation
Official title: Multidetector CT Left Appendage Atrial Thrombosis Exclusion in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in whom there is a doubt of thrombosis in the early arterial phase.

Brief summary: The aim of the LATE (multidetector CT Lefi Appendage atrial Thrombosis Exclusion in patients with atrial fibrillation) study is to evaluate the diagnostic accuracy of cardiac Computed Tomography (TC) with 64 detectors and double acquisition phase in candidate patients ablation of atrial fibrillation (AF) with the Navx (or Carto) technique, using trans-esophageal ultrasound (TEE) as the standard reference.

This study is based on the use of an experimental protocol in cardiac TC which involves, in addition to the acquisition of an early arterial phase (standard protocol routinely performed in all patients), the execution of a possible late phase at a very low dose of radiation (experimental protocol) aimed at increasing the accuracy of the method in the diagnosis in patients with AF. The LATE study aims to demonstrate the high diagnostic accuracy of dual acquisition phase cardiac TC in the diagnosis of intraauricular thrombosis by comparing it with reference standard; in light of this result, cardiac TC could constitute a single non-invasive diagnostic tool in the future for the global evaluation of both atrial anatomy and endoawicular thrombosis with a clear improvement in patient management both in clinical and economic terms.


Eligibility criteria: Inclusion Criteria:

* patients candidates for cardiac TC and transesophageal ultrasound examination for the evaluation of cardiac anatomy and for the exclusion of intra-auricular thrombosis.

Exclusion Criteria:

* \< 18 years patients

Primary outcomes:
measure: Cardiac computed tomography for the staging of patients with intraauricular thrombosis.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06413732: The Effect of Dual Task Training in Patients With Stroke
Official title: The Effect of Dual Task Training on Gait, Balance, and Quality of Life in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effect of dual-task training on gait, balance, and quality of life in individuals with stroke. The study included 30 individuals aged 30-80 years with stroke. All participants were assessed using the 10-meter walk test (10MWT), 10MWT under dual-task interaction (DTI), timed up and go (TUG), 30-Second Chair-Stand Test (30s-CST), Berg Balance Scale (BBS), Short Form 36 (SF-36). Participants were randomized into two groups. Both groups received conventional physiotherapy for approximately 1 hour, five days a week. Group I also received dual-task training.


Eligibility criteria: Inclusion Criteria:

* Having a score of 24 or above on the Mini-Mental State Test,
* Being able to walk at least 10 meters without using a walking aid
* Having a total score of 5 on the motor and cognitive sections of the Functional Independence Scale.

Exclusion Criteria:

* Neurological and orthopedic problems that could affect motor performance and balance
* Communication problems
* Patients who had received Botulinum Toxin injection treatment in the last six months

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Six weeks
measure: Timed Up and Go Test
timeFrame: Six weeks
measure: 10-meter walk test
timeFrame: Six weeks
measure: 30-Second Chair-Stand Test
timeFrame: Six weeks
measure: Short Form 36
timeFrame: Six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karabuk
country: Turkey
facility: Tarik Ozmen
Study officials:
References:
Clinical trial NCT00917332: Effects of Relaxation and Guided Imagery Training on Pain at Childbirth
Official title: Effects of Relaxation and Guided Imagery Training on Rate and Time of Receiving Regional Anesthesia (Epidural), and on the Experience of Childbirth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain at Childbirth
Keywords: pain
childbirth
relaxation
guided imagery
VAS
epidural
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether relaxation and guided imagery techniques are effective in reducing childbirth pain.


Eligibility criteria: Inclusion Criteria:

* women who carry their first child
* women that carry only one embryo
* women who speaks hebrew

Exclusion Criteria:

* women who experienced complications in pregnancy.
* women who planning on having an elective Caesarean section.
* women who suffer from background systematic condition (such as high-BP, diabetes).
* women who have psychiatric background.
* women who take chronic medication that might effect childbirth, woman or baby's health.

Primary outcomes:
measure: rating of pain experienced during childbirth on pain VAS
timeFrame: one time - during hospitalization after childbirth
Secondary outcomes:
measure: rate and the starting time of receiving regional anesthesia (epidural)
timeFrame: at childbirth
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Ein-Kerem Haspitol
Study officials:
affiliation: hadassah ein-kerem - obstetrics and gynecology
name: david mankuta, MD
role: PRINCIPAL_INVESTIGATOR
References: