louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00799123: Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature
Ductus Arteriosus, Patent
Ventricular Function, Left
Keywords: NT-proBNP
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2008-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 24
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: VLBW infants

Brief summary: The aim of the study is to evaluate urine NT-proBNP levels and new Echocardiographic Findings in VLBW infants. The investigators hypothesize that high urine NT-proBNP concentrations are associated with a hemodynamically significant ductus arteriosus. The investigators also hypothesized that new echocardiographic parameters such as isovolumic relaxation time (IVRT)is useful for the prediction of ductus intervention.

Detailed description: Urine samples were collected within 24 to 48 hours of age, on day 7, on day 14 and on day 28 of life. The samples were spun and the platelet-free urine was stored at -80°C until NT-proBNP analysis. The NT-proBNP assay was performed with an automated immunoassay (Roche Diagnostics). Color Doppler and tissue Doppler echocardiography was determined at the same time as the urine collection. New echo parameters such as IVRT, tissue velocity, strain and strain rate were measured and compared with the standard parameters for significant ductus arteriosus. Furthermore we compared the tissue Doppler measurements with clinical findings.

Eligibility criteria: Inclusion Criteria:

* Written parental informed consent
* VLBW infants
* Admitted to our NICU within 48 hours after birth

Exclusion Criteria:

* No written parental informed consent
* Congenital heart disease
* Death

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite, Medical University
Study officials:
affiliation: Charite, Medical University Berlin
name: Christoph Czernik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05892523: Influence of Spinal Deformity on THA
Official title: Influence of Spinal Deformity on Acetabular Cup Position in THA.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: THA
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from 30 to 70 years old with primary THA and spinal deformity

Brief summary: The aim of the study is to understand the effect of spinal deformity and altered sagittal plane parameters of lumbosacral complex on acetabular cup position in THA.

Detailed description: Investigators will Find out if there is change in the acetabular cup including the abduction and anteversion angles in patients who had THA and has spinal deformity

Eligibility criteria: Inclusion Criteria:

* all patients who had primary THA in 6 month duration
* patients from 30 to 70 years old with primary THA

Exclusion Criteria:

* patients who have ankylosing spondylitis
* patients with revised THA
* patients with associated injuries in lower limb

Primary outcomes:
measure: change of acetabular cup position in spinal deformity
timeFrame: immediate post operative X-ray hip anteroposterior and cross table lateral views in supine position measuring cup abduction and anteversion angles and 3 month post operative X-ray hip and lumbosacral anteroposterior and lateral views in standing position
Secondary outcomes:
measure: complications of THA mainly hip dislocation and HOOS hip survey
timeFrame: 3 month duration post operatively
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hatem M Abdel-Moneim Bakr, professor
role: STUDY_CHAIR
References:
citation: Phan D, Bederman SS, Schwarzkopf R. The influence of sagittal spinal deformity on anteversion of the acetabular component in total hip arthroplasty. Bone Joint J. 2015 Aug;97-B(8):1017-23. doi: 10.1302/0301-620X.97B8.35700.
citation: Blizzard DJ, Nickel BT, Seyler TM, Bolognesi MP. The Impact of Lumbar Spine Disease and Deformity on Total Hip Arthroplasty Outcomes. Orthop Clin North Am. 2016 Jan;47(1):19-28. doi: 10.1016/j.ocl.2015.08.005.
Clinical trial NCT00730223: Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
Official title: Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Nevirapine
Efavirenz
pharmacokinetics
healthy
CYP2B6
HIV/AIDS
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz.


Eligibility criteria: Inclusion Criteria:

* Healthy African American men and women.
* 18-55 years of age.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Currently or recently (within the previous 30 days) received medications known or likely to be metabolized by, or interact wth the CYP450 enzymes.
* Prior or current hepatic or psychiatric disease illness that in the judgment of the investigator would interfere in the study performance.
* Active alcohol or illicit drug abuse use that in the judgment of the investigator would interfere in the study performance.
* Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \>1.5 X upper limit of normal.
* Positive pregnancy test in women of childbearing potential.

Primary outcomes:
measure: Pharmacokinetics of single dose nevirapine and single dose efavirenz
timeFrame: 5-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor of Medicine
name: David W Haas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06504823: The Effect of Light Level Applied During Breastfeeding on Maternal Stress, Anxiety, Psychological Well-being and Breastfeeding Motivation
Official title: The Effect of Light Level Applied During Breastfeeding on Maternal Stress, Anxiety, Psychological Well-being and Breastfeeding Motivation Randomize Plasebo kontrollü çalışma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 60
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: To determine the effect of the light level applied during breastfeeding on the mother's stress, anxiety, psychological well-being and breastfeeding motivation. This research was planned as a single-blind randomized controlled experimental type study comparing separate groups as intervention-placebo controlled. Data will be collected with the Introductory Information Form, Psychological Well-Being Scale, Perceived Stress Scale (ASÖ/PSÖ-14), State-Trait Anxiety Inventory (STAI) and Breastfeeding Motivation Scale (For Primiparous Mothers). The effect of two different light levels on mothers will be examined.


Eligibility criteria: Inclusion Criteria:

* being 18 years of age or older, volunteering.

Exclusion Criteria:

* Having any problem that prevents communication

Primary outcomes:
measure: stress
timeFrame: 1 day
Secondary outcomes:
measure: anxiety
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02924623: Discrepancies Between Patients and Physicians in Their Perceptions of Rheumatoid Arthritis Disease Activity
Official title: Discordance Dans l'évaluation d'Activité de la Polyarthrite Rhumatoide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: from the south of France (Nîmes, Montpellier, Toulouse, Bordeaux, Limoge), fulfilling the ACR-EULAR criteria for RA

Brief summary: Patients and physicians often differ in their perceptions of rheumatoid arthritis (RA) disease activity, as quantified by the patient's global assessment (PGA) and by the evaluator's global assessment (EGA).

The objectives of this study were:

1. to explore the extent and reasons for the discordance between patients and physicians in their perception of RA disease activity
2. to determine if this discordance at baseline is associated with RA outcomes at 1 year (remission, function and structure) in early arthritis (EA) in daily clinical practice.

   * Patients: from the French cohort of early arthritis (EA) ESPOIR³ (at least 2 swollen joints for less than 6 months, DMARD naïve), fulfilling the ACR-EULAR criteria for RA at baseline

Analysis: At baseline, agreement between PGA and EGA (Bland-Altman plot) was assessed. Multivariate linear regression was used to determine the patient and EA features independently associated with discordance (calculated as PGA - EGA). Logistic regression was used to analyze discordance as│PGA - EGA│≥20.

Multivariate logistic models were used to determine if discordance at baseline is associated with remissions (Boolean, SDAI and DAS28), functional stability (HAQ≤0.5 and deltaHAQ≤0.25) and absence of radiographic progression (delta Sharp score\<1) after 1 year of follow-up.


Eligibility criteria: Inclusion Criteria:

* fulfilling the ACR-EULAR criteria for RA

Exclusion Criteria:

* no RA

Primary outcomes:
measure: Patient's global assessment
timeFrame: day 0
measure: Evaluator's global assessment
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nîmes
state: Gard
Study officials:
affiliation: CHU Nîmes
name: Cécile Gaujoux-Viala, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02935023: Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer
Official title: Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Prostate Carcinoma
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 47
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical study is to determine impact of carbon ion radiotherapy (CIRT) treatment in combination with systemic therapy for oligo-metastatic prostate cancer. The primary objective: to determine disease biochemical progression-free survival in man with oligo-metastatic (M1a/b) prostate cancer undergoing systemic therapy with definitive radiotherapy of the primary tumor. The secondary objective: to determine local control, overall survival and quality of life in men with oligo-metastatic prostate cancer undergoing carbon ion radiotherapy


Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed adenocarcinoma of the prostate
2. Age ≥ 20 and \< 80 years of age
3. ECOG PS 0 or 1
4. Life-expectancy ≥1 year
5. Stage T1-4,N0-1,M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.
6. Ability to understand and willingness to sign informed consent

Exclusion Criteria:

1. No pathologically confirmed adenocarcinoma of the prostate
2. visceral metastasis
3. Previous pelvic radiotherapy or prostatectomy
4. Severe systemic disorders

Primary outcomes:
measure: Time to PSA relapse
timeFrame: From the start of systemic therapy, a median of 2 years
Secondary outcomes:
measure: progression free survival
timeFrame: From the start of systemic therapy, a median of 2 years
measure: Overall survival
timeFrame: From the start of systemic therapy, a median of 2 years
measure: Quality of life
timeFrame: From the start of carbon ion radiotherapy, a median of 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center
name: Shen Fu, PhD.MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06911723: Activities to Change Your Mood: A Test of the Acceptability and Initial Efficacy in Clinical Samples and Healthy Controls
Official title: Activities to Change Your Mood: A Test of the Acceptability and Initial Efficacy in Clinical Samples and Healthy Controls
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia Disorders
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study investigating how brief online activities can influence mood and attitudes.


Eligibility criteria: Inclusion Criteria:

* aged 18-65
* schizophrenia group - have a psychotic disorder diagnosis
* healthy control group - Do not have a current DSM-5 diagnosis via the SCID-5

Primary outcomes:
measure: Patient Health Questionnaire - PHQ-9
timeFrame: Assessed at baseline (day 1) and after study completion, an average of a week
measure: Generalized Anxiety Disorder 7-item - GAD-7
timeFrame: Assessed at baseline (day 1) and after study completion, an average of a week
measure: The Motivation and Pleasure Scale-Self-Report - MAP-SR
timeFrame: Assessed at baseline (day 1) and after study completion, an average of a week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04319523: Abnormal Pain Processing in COPD Patients
Official title: Abnormal Pain Processing in COPD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Pain
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 65
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stable COPD patients with a grade III and IV of Global Initiative for Chronic Obstructive Lung Disease (GOLD). Patients were recruited in the pneumology services of San Cecilio and Virgen de las Nieves University Hospitals (Granada, Spain).

Brief summary: Dyspnea, cough, and fatigue are the symptoms characteristic of moderate-severe COPD. Within the progression of disease was also reported a prevalence of 34-77% of pain symptoms in these patients. A review observed a higher score in pain intensity/interference associated with multiples pain locations of COPD patients. Pain in chronic diseases may appear to result from abnormalities in pain processing because of the damage and/or inflammation of peripheral structures.

Detailed description: Dyspnea, cough, and fatigue are the symptoms characteristic of moderate-severe COPD. Within the progression of disease was also reported a prevalence of 34-77% of pain symptoms in these patients. A review observed a higher score in pain intensity/interference associated with multiples pain locations of COPD patients. Several studies reported that comorbidities, GOLD grade, and breathlessness may contribute to a higher pain prevalence in COPD patients because of the systemic inflammatory process and lung hyperinflation. Pain in chronic diseases may appear to result from abnormalities in pain processing and alteration of sensitization due to the damage and/or inflammation of peripheral structures.

Eligibility criteria: Inclusion Criteria:

* Between 50 and older age
* Accepted to sign the informed consent

Exclusion Criteria:

* comorbidities with a course of chronic pain that interfered with evaluation
* the presence of cognitive impairment to understand the questionnaire

Primary outcomes:
measure: Pressure pain thresholds
timeFrame: Baseline
measure: Temporal summation
timeFrame: Baseline
Secondary outcomes:
measure: Pain Sensitivity Questionnaire
timeFrame: Baseline
measure: Borg scale
timeFrame: Baseline
measure: International Physical Activity Questionnaire
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: London Chest Activity of Daily Living
timeFrame: Baseline
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences. University of Granada.
state: Andalucia
Study officials:
References:
Clinical trial NCT06237023: The Impact of the Covid-19 Pandemic on Orthopedic Trauma Management
Official title: The Impact of the Covid-19 Pandemic on Orthopedic Trauma Management; a Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
COVID-19 Pandemic
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-01
Enrollment: 57635
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The aim of the study is to compare emergency orthopedic trauma admissions between the pre-pandemic period and the pandemic period and to detect changes in orthopedic trauma epidemiology.

Detailed description: The aim of the study is to compare emergency orthopedic trauma admissions between the pre-pandemic period and the pandemic period and to detect changes in orthopedic trauma epidemiology. For this purpose, an epidemiological study was conducted in our country, comparing trauma admissions to a level 1 trauma hospital during a one-year period before the pandemic with those in the year following the onset of the pandemic.Demographic characteristics of the patients, such as age and gender, were recorded. In addition, the injury mechanisms of the patients, diagnosis, injured extremityor anatomical region, broken bone, fracture classification, multitrauma rates, trauma releated complications, hospitalization days, and treatment modalities were examined.

Eligibility criteria: Inclusion Criteria:

* The patients who were admitted between March 2019 and March 2021
* Patients presenting due to trauma

Exclusion Criteria:

* Patients Admitted Before the Pandemic and Outside the Pandemic Period
* Consultation or Outpatient Clinic Patients
* Non-Traumatic Conditions
* Patients with Incomplete Records

Primary outcomes:
measure: Comparison of Emergency Orthopedic Trauma Admissions Between Pre-Pandemic and Pandemic Period
timeFrame: up to 6 months
measure: Detection of Changes in the Epidemiology of Orthopedic Trauma
timeFrame: up to 6 months
Secondary outcomes:
measure: Changes in Patient Demographic Characteristics
timeFrame: 6 weeks
measure: Comparison of Injury Mechanisms and Diagnoses
timeFrame: 8 weeks
measure: Injured Extremities or Anatomical Regions
timeFrame: 8 weeks
measure: Fracture Types and Classifications
timeFrame: 6 weeks
measure: Trauma-Related Complications
timeFrame: 6 months
measure: Treatment Methods
timeFrame: 8 weeks
measure: Length of Hospital Stay
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences, Hamidiye Medical School, Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology
Study officials:
References:
Clinical trial NCT00948623: Physical Activity Counseling During Pulmonary Rehabilitation
Official title: Physical Activity Counseling During Pulmonary Rehabilitation: Does it Improve Daily Physical Activity Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
physical activity
pulmonary rehabilitation
counseling
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2009-07-29
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial will assess the effect of adding intensive physical activity counseling to an outpatient pulmonary rehabilitation program. Counseling including real-time feedback on daily activities from an activity monitor will be offered to improve participation in physical activities in daily life during and after an outpatient pulmonary rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Spirometry-proven COPD
* Referred for 6-month outpatient pulmonary rehabilitation program

Exclusion Criteria:

* Orthopedic problems impairing daily activities
* Progressive neurological or neuromuscular disorders
* Psychiatric or cognitive disorders
* Patients on the waiting list for lung transplantation

Primary outcomes:
measure: Walking time in daily life and the amount of time spent in moderate intense activities
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Rehabilitation Sciences, University Hospitals KULeuven
state: Vlaams-Brabant
Study officials:
References:
citation: Burtin C, Langer D, van Remoortel H, Demeyer H, Gosselink R, Decramer M, Dobbels F, Janssens W, Troosters T. Physical Activity Counselling during Pulmonary Rehabilitation in Patients with COPD: A Randomised Controlled Trial. PLoS One. 2015 Dec 23;10(12):e0144989. doi: 10.1371/journal.pone.0144989. eCollection 2015.
citation: Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.