louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04949724: Turkish Health Enhancement Lifestyle Profile-Screener Questionnaire
Official title: Psychometric Properties of The Turkish Health Enhancement Lifestyle Profile-Screener Questionnaire (T-Help-Screener)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly Population
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: elderly people

Brief summary: The aim of this study was to evaluate the validity, reliability, and cultural adaptation of the Turkish version of the Health Enhancement Lifestyle Profile Screener (T-HELP-Screener).

Detailed description: Internal consistency of the T-HELP-Screener was measured using Kuder-Richardson. Test-retest reliability was performed with 66 of the 150 participants using intraclass correlation coefficient (ICC). Construct validity of the T-HELP-Screener was analyzed with the Healthy Lifestyle Behavior Scale-II (HLBS-II).

Eligibility criteria: Inclusion Criteria:

age over 65 years, no communication problems, and a Mini-Mental State Examination score of 24 or above

Exclusion Criteria:

communication problem

Primary outcomes:
measure: Healthy Lifestyle Behavior Scale-II
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Özgü İnal
state: Merkez
Study officials:
References:
Clinical trial NCT01907724: Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)
Official title: A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C, Chronic
Keywords: Chronic hepatitis C
Hepatitis C virus
HCV
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2013-07-25
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug
* Male participants agree not to donate sperm from Day -1 through 90 days after the last dose of study drug

Exclusion Criteria:

* Is pregnant or breastfeeding
* Has another clinically significant medical conditions or laboratory abnormality(s)

Primary outcomes:
measure: Observed maximum plasma drug concentration (Cmax)
timeFrame: Up to 14 days
measure: Time to maximum concentration (Tmax)
timeFrame: Up to 14 days
measure: Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t)
timeFrame: Up to 14 days
measure: Predose trough concentration (Ctrough)
timeFrame: Up to 14 days
measure: Apparent terminal elimination rate constant
timeFrame: Up to 14 days
measure: Observed terminal half-life (T1/2)
timeFrame: Up to 14 days
Secondary outcomes:
measure: Percentage of participants experiencing serious adverse events (SAEs)
timeFrame: Up to 28 days
measure: Percentage of participants experiencing adverse events (AEs)
timeFrame: Up to 28 days
measure: Percentage of participants with Grade 1-4 laboratory abnormalities
timeFrame: Up to 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04670224: Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery
Official title: Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Quadratus Lumborum Block
Abdominoplasty
Analgesia
Locoregional Anesthesia
Keywords: Quadratus lumborum block
Abdominoplasty
Analgesia
Locoregional Anesthesia
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 286
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: Abdominoplasty is a common surgical procedure in plastic surgery which causes postoperative pain and may delay patients' recovery. Surgery is potentially associated with a number of postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or digestive ... Although they do not inevitably lead to a life-threatening prognosis, in many cases these complications delay post-operative recovery. Defined in the 1990s by Professor Henry Kehlet's Danish team, rapid rehabilitation after planned surgery is an approach to overall patient care that aims to rapidly restore previous physical and mental capacities and thus significantly reduce mortality and morbidity. Pain management is at the heart of this program and local anesthesia techniques are at the heart of early rehabilitation programs.

Described for just over a decade, Quadratus Lumborum Block (QLB) have shown their effectiveness for analgesia in abdominal, or orthopedic, or obstetrical surgery. Considering the anatomical territory concerned, this locoregional anesthesia technique seems to be very interesting in abdominoplasty to allow early rehabilitation of the patient.


Eligibility criteria: Inclusion Criteria:

* Adult patients admitted for programmed dermo-lipectomy surgery with or without associated liposuction.

Exclusion Criteria:

* Pregnant woman
* Patient under 18 years of age
* Subject under guardianship or curators
* Patient allergic to local anesthetics
* Infection at the puncture sites
* Patient on morphine analgesic over the long term
* Patient on antidepressants for neuropathic pain.

Primary outcomes:
measure: Variation from baseline of morphine consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Variation from baseline of morphine consumption
timeFrame: 1 hour after surgery
measure: Variation from baseline of morphine consumption
timeFrame: 2 hours after surgery
measure: Variation from baseline of morphine consumption
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: BAR
Study officials:
References:
Clinical trial NCT01463124: School Nurse Intervention and After School Exercise Program for Overweight Teens
Official title: School Nurse Intervention and After School Exercise Program for Overweight Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight
Obesity
Keywords: School Nurse
Overweight
Obesity
Counseling
Intervention
Exercise
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2011-11-01
Enrollment: 126
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adolescent overweight and obesity have increased dramatically in the past several decades. High schools are well-positioned to deliver weight loss treatment to overweight and obese adolescents, as they have the facilities and staff to deliver a physical activity program, school nurses with the skills to provide counseling, and are easily accessible by adolescents. This exploratory study will test the feasibility and ability of a school-based intervention, consisting of school nurse counseling and a school-based exercise program, to reduce BMI and improve dietary quality, physical activity, and sedentary behaviors in overweight and obese adolescents. If effective, this could prove to be a cost-effective and relatively easy intervention to disseminate widely for significant public health impact.


Eligibility criteria: Inclusion Criteria:

* enrolled in grades 9 - 12
* BMI \> 85th percentile for age/sex
* able to understand and participate in the study
* able and willing to provide informed assent (adolescent) and consent (parent)
* English-speaking with at least one English-speaking parent

Exclusion Criteria:

* planning to move out of the area within the next 8 months
* medical condition that precludes adherence to study dietary recommendations (e.g., pregnancy, Crohn's disease, ulcerative colitis)
* diagnosis of a serious psychiatric illness (e.g., psychiatric hospitalization, eating disorder, suicidal) within the past 5 years
* genetic or endocrine causes of obesity (e.g., pradi Willi, Cushing's Syndrome)
* developmental delay that would prevent participation in the intervention or measurements
* prescribed medications associated with weight gain (e.g.,oral steroids)
* morbidly obese, defined as weighing \> 300 pounds

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: One academic year (8 months)
measure: Participation in exercise program
timeFrame: One academic year (8 months)
Secondary outcomes:
measure: Self-management
timeFrame: One academic year (8 months)
measure: Physiologic outcomes
timeFrame: One academic year (8 months)
measure: Psychosocial outcomes
timeFrame: One academic year (8 months)
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Lori Pbert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04168424: Validation of the English Version of the FIMA Questionnaire
Official title: Validation of the English Version of the FIMA Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elderly Persons
Keywords: resource use
assessment
elderly
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 60 elderly people 65 years of age and older, who will be admitted within the previous 48 hours to Gessler Clinic USA, will be recruited. The participants will be excluded if they have severe visual or auditory impairment, are likely to pass away within 24 hours, have a poor command of English, or are unwilling to participate. No individuals with cognitive impairments will be included in this study. Each patient will be evaluated twice: once within 48 hours at admission and once after two weeks.

Brief summary: The purpose of this study was to determine the validity and reliability of the English version of the Questionnaire for Health-Related Resource Use in an Elderly Population (FIMA).


Eligibility criteria: Inclusion Criteria:

-65+.

Exclusion Criteria:

* younger than 65+
* severe visual impairment
* severe auditory impairment
* poor command of English
* no consent to participate in the study

Primary outcomes:
measure: Good validity and reliability of the FIMA
timeFrame: 11.2019-12.2020
Secondary outcomes:
Other outcomes:
Locations:
city: Winter Haven
country: United States
facility: Gessler Clinic
state: Florida
Study officials:
References:
citation: Mazurek J, Sutkowska E, Szczesniak D, Urbanska KM, Rymaszewska J. FIMA, the questionnaire for health-related resource use in the elderly population: validity, reliability, and usage of the Polish version in clinical practice. Clin Interv Aging. 2018 Apr 27;13:787-795. doi: 10.2147/CIA.S158951. eCollection 2018.
citation: Seidl H, Hein L, Scholz S, Bowles D, Greiner W, Brettschneider C, Konig HH, Holle R. [Validation of the FIMA Questionnaire for Health-Related Resource Use Against Medical Claims Data: The Role Played by Length of Recall Period]. Gesundheitswesen. 2021 Jan;83(1):66-74. doi: 10.1055/a-1010-6315. Epub 2019 Nov 7. German.
Clinical trial NCT02860624: Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients
Official title: Efficacy and Safety of Ilaprazole for GERD: A Randomized, Double-Blind, Esomeprazole-Controlled, Phase 3, Multicenter Trial in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Lead sponsor: Livzon Pharmaceutical Group Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-09
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.


Eligibility criteria: Inclusion Criteria:

* Consenting patients will be eligible for enrollment if they:
* are 18-70 years of age,
* have at least one of the two symptoms, heartburn and reflux,
* have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test.

Exclusion Criteria:

* Patients will be ineligible if they:
* have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach
* have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
* have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
* have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
* participated in a clinical trial with an investigational drug or device within the past three months,
* have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole,
* have alcoholic intemperance, drug addiction or any other improper habits.

Primary outcomes:
measure: Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels.
timeFrame: week 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Xue Y, Qin X, Zhou L, Lin S, Wang L, Hu H, Xia J. A randomized, double blind, controlled, multi center study of Ilaparazole in the treatment of reflux esophagitis-Phase III clinical trial. Contemp Clin Trials. 2018 May;68:67-71. doi: 10.1016/j.cct.2018.03.004. Epub 2018 Mar 11.
Clinical trial NCT02800824: Bioequivalence Study of Budesonide Rectal Aerosol Foam and Uceris® Rectal Aerosol Foam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2016-06-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To evaluate the bioequivalence between the Test Product Budesonide rectal aerosol foam and Reference Product Uceris® rectal aerosol foam after a single-dose in healthy subjects


Eligibility criteria: Inclusion Criteria:

1. Healthy, non-smoking, male and female subjects, 18 years of age or over.
2. No clinically significant findings in vital signs measurements or 12-lead electrocardiogram (ECG) or abnormal laboratory values.
3. Have no significant diseases.
4. Willing to use an acceptable, effective method of contraception.
5. Informed on the nature of the study and have agreed to and are able to read, review and sign all consent documents.
6. Have no clinically significant findings from a physical examination.

Exclusion Criteria:

1. Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
2. Known history or presence of hypersensitivity or idiosyncratic reaction to budesonide, any other components of the drug products, or any other drug substances with similar activity or sodium phosphate
3. History or presence or of diabetes mellitus, glaucoma or cataracts, hypertension, or osteoporosis
4. History of drug or alcohol addiction requiring treatment.
5. History of malabsorption within the last year.
6. Presence of hepatic or renal dysfunction.
7. Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
8. Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.

Primary outcomes:
measure: Maximum observed plasma drug concentration (Cmax)
timeFrame: 24 hours
measure: AUC from time 0 extrapolated to infinity (AUC0-∞)
timeFrame: 24 hours
measure: AUC from time 0 to 24 hours (AUC0-24)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04255524: Choroidal Change on OCTA in Eyes With High Myopia
Official title: OCTA to Quantify the Parapapillary Choroidal Microvascular Changes in High Myopia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Choroid Disease
Keywords: OCTA
Myopia
Choroid
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Myopia is a global healthy concern, especially the high myopia and pathological myopia among Asian populations. However, its mechanism still remains largely unclear. Recent findings suggested choroidal changes might be related to the development of myopia. This study is to useOCT angiography (OCT-A) to investigate parapapillary choroidal microvasculature change in myopic eyes, and try to find the cause-and-effect relationship between choroidal change and the development of myopia.


Eligibility criteria: Inclusion Criteria:

1. Spherical equivalent measurement can be included in above 4 groups
2. Willing to be followed up in the future 10 years

Exclusion Criteria:

1. Deny to sign the patient consent, or deny to be followed
2. Evidence of cardiac, or diabetic, or CNS disease.
3. Clinically diagnosed with retinal or choroidal disease
4. Glucoma
5. Cataract or corneal disease that influence the quality of fundus OCTA image

Primary outcomes:
measure: Parapapillary choroidal microvasculature void (MvV) area
timeFrame: changes of MvV area from at 10 years
measure: Parapapillary choroidal microvasculature void (MvV) area
timeFrame: difference of MvV area in each group at baseline
measure: Parapapillary choroidal microvasculature void (MvV) area
timeFrame: changes of MvV area at 1 years
measure: Parapapillary choroidal microvasculature void (MvV) area
timeFrame: changes of MvV area at 3 years
measure: Parapapillary choroidal microvasculature void (MvV) area
timeFrame: changes of MvV area at 5 years
Secondary outcomes:
measure: MvV number
timeFrame: baseline
measure: Correlation coefficient between choroidal MvV and refractive power
timeFrame: baseline
measure: Correlation coefficient between choroidal MvV and PPA area
timeFrame: baseline
measure: Correlation coefficient between choroidal MvV and choroid thickness
timeFrame: baseline
measure: Correlation coefficient between choroidal MvV and RNFL thickness
timeFrame: baseline
measure: Correlation coefficient between choroidal MvV and Axial length
timeFrame: baseline
measure: Correlation coefficient between choroidal MvV and retinal parapapillary perfusion
timeFrame: baseline
measure: Correlation coefficient between choroidal MvV and Macular perfusion
timeFrame: baseline
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01941524: Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations
Official title: Assessment of the Cerebral Tissue Oxygenation and the Bioelectrical Brain Activity of Preterm Newborns During Administration of Two Different Surfactant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Distress Syndrome, Newborn
Respiratory Failure
Keywords: Brain oxygenation
NIRS
aEEG
surfactant
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 22
Sex: ALL
Minimum age (years): 15
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and after instillation of two different surfactant preparations.

Detailed description: Patients randomized to one of the treatment groups: 1) SRT with porcine preparation - poractant alfa; 2) SRT with bovine preparation - beractant. Continuous monitoring and simultaneous recordeding of 1) saturation (SpO2) and heart rate (HR) measured with pulse oximetry, cerebral tissue oxygenation measured with near-infrared spectroscopy, amplitude-integrated electroencephalography.

Eligibility criteria: Inclusion Criteria:

* 26-30 gestational age
* surfactant instillation

Exclusion Criteria:

* congenital heart disease
* congenital central nervous disorder
* congenital genetic disorders

Primary outcomes:
measure: Cerebral oxygenation
timeFrame: 4 hours after surfactant instillation
measure: Brain bioelectrical activity
timeFrame: 4 hours after surfactant instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Department of Neonatology
state: Great Poland
Study officials:
affiliation: Poznan University of Medical Sciences
name: Tomasz Szczapa, M.D.
role: STUDY_DIRECTOR
References: