louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00638261: Primary UVB-311nm and Adalimumab in Psoriasis Patients
Official title: Adalimumab in Primary Combination With UVB-311nm Half-side Phototherapy in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Psoriasis
Biologic
Adalimumab
Narrow-band UVB
phototherapy
half-side comparison
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. However, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study we aim to determine in a randomized half-side comparison whether initial narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated patients.

Detailed description: Patients with moderate to severe psoriasis who are scheduled to receive a standard treatment course of adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to \< 3). PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction \> 90%, \> 75% and/or 50% between body sites.

Eligibility criteria: Inclusion Criteria:

* Psoriasis patients who are scheduled for treatment with adalimumab.

Exclusion Criteria:

* Pregnancy or lactation
* History of skin cancer
* Presence of or history of malignant skin tumors
* Dysplastic melanocytic nevus syndrome
* Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
* Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
* Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
* General poor health status

Primary outcomes:
measure: Modified PASI (psoriasis area and severity index)
timeFrame: 12 months
Secondary outcomes:
measure: Patient visual analogue score (VAS) for therapeutic effect
timeFrame: 12 months
measure: Patient VAS for severity of skin lesions
timeFrame: 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Department of Dermatology
Study officials:
affiliation: Medical University of Graz, Austria
name: Peter Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06139861: Better Sleep Study
Official title: A Confirmatory Efficacy Trial of Engaging a Novel Sleep/Circadian Rhythm Target as Treatment for Depression in Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression in Adolescence
Delayed Sleep Phase
Keywords: Depression
Adolescents
Sleep
Intervention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Stanford University
name: National Institute of Mental Health (NIMH)
First posted: 2023-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aim of this proposal is a confirmatory efficacy trial sufficiently powered and designed to test the hypothesis that improving the relationship between biological circadian timing and waketime, a novel modifiable target, improves depression outcomes in a subgroup of adolescents with depression and a misaligned relationship between biological circadian timing and waketime utilizing a cognitive-behavioral sleep intervention.


Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

* mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; Bipolar Disorder; drug dependence
* severe or unstable medical or psychiatric condition such that treatment has changed within the last month or is expected to change during the course of the study or that would preclude ability to adhere to study procedures (e.g. terminal end-stage cancer)
* current use of medications or herbs with known effects on sleep
* plan to undergo or have had medication change in the last 8 weeks

Primary outcomes:
measure: Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME )
timeFrame: baseline to end of treatment (0 and 2 months)
measure: Change in Children's Depression Rating Scale (CDRS-R)
timeFrame: baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Nancy Friend Pritzker Psychiatry Building
state: California
Study officials:
References:
Clinical trial NCT02986061: To Catheterize or Not? in Total Knee Arthroplasty With Combined Spinal-epidural Analgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Catheter
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 200
Sex: MALE
Minimum age (years): 40
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 whether urinary catheterization could be avoided for all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia plus multi-site infiltration analgesia.


Eligibility criteria: Inclusion Criteria:

* Aged 40 years and older, who were scheduled for a primary TKA for end-stage osteoarthritis and those who were willing and able to return for follow-up over at least a 1-month postoperative period.

Exclusion Criteria:

* Revisions, bilateral procedures, surgical history of urinary system, urinary tract infection and systematical conditions (renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery) needing intraoperative monitoring urine output.

Primary outcomes:
measure: Postoperative urinary retention
timeFrame: 7 days
measure: Postoperative urinary tract infection
timeFrame: 7 days
measure: Urine volume
timeFrame: 3 days
Secondary outcomes:
measure: Length of stay
timeFrame: 14 days
measure: Intraoperative intravenous fluid
timeFrame: 1 day
measure: Duration of the surgery
timeFrame: 1 day
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Center for Joint Surgery, Southwest Hospital, Third Military Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT05266261: Use of Ibandronate in Diabetic Patients
Official title: Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Postmenopausal
Type 2 Diabetes
Lead sponsor: Yeouido St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Seoul National University Bundang Hospital
First posted: 2022-03-04
Enrollment: 121
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether monthly oral administration of ibandronate to postmenopausal osteoporosis patients with type 2 diabetes differs in safety and efficacy compared to patients without diabetes.

Detailed description: There are two major considerations in the use of bisphosphonates in diabetic patients.

* The low rate of bone turnover in diabetic patients is at risk of side effects such as excessive inhibition of bone turnover associated with the use of bisphosphonates.
* A decrease in osteocalcin following bisphosphonate use may lead to deterioration of glucose metabolism.

The efficacy of ibandronate in T2DM is not thought to be significantly different based on previous studies, but there is few study on ibandronate.

Eligibility criteria: Inclusion Criteria:

* age of at least 55 years at the time of screening
* postmenopausal woman
* diagnosis of osteoporosis

Exclusion Criteria:

* history of osteoporosis treatment
* underlying disease (e.g., heart failure, liver disease, renal disease, or malignancy)
* the use of drugs that affect bone metabolism (e.g., steroids, immunosuppressants, gonadotropin-releasing hormone agonists, aromatase inhibitors, thiazolidinedione drugs, anticonvulsants, and antidepressants)
* history of adverse effects of bisphosphonate or difficulty taking the drug due to an inability to sit or the presence of upper gastrointestinal disease

Primary outcomes:
measure: Bone mineral density
timeFrame: 1 year
Secondary outcomes:
measure: Bone turnover markers
timeFrame: 6 month and 12 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yeouido St.Mary's Hospital
Study officials:
affiliation: Yeouido St. Mary's Hospital
name: Ki-Hyun Baek, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim J, Kim KM, Lim S, Kang MI, Baek KH, Min YK. Efficacy of bisphosphonate therapy on postmenopausal osteoporotic women with and without diabetes: a prospective trial. BMC Endocr Disord. 2022 Apr 11;22(1):99. doi: 10.1186/s12902-022-01010-w.
Clinical trial NCT05483361: Effect Of Smart Phone Addiction On Pulmonary Function, And Functional Capacity In Children
Official title: Effect Of Smart Phone Addiction On Pulmonary Function, And Functional Capacity In Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smartphone Addiction
Pulmonary Function
Functional Capacity
School Age Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Statement of the problem:

Are there relations between smartphone addiction, neck posture, pulmonary functions and functional capacity in children? Null hypothesis

It will be assumed that:

* There will be no effect of smart phone addiction on head posture, pulmonary function and functional capacity in children.
* There will be no relation between smartphone addiction, head posture, pulmonary function and functional capacity in children.

Detailed description: Subjects:

Sample size estimation will be carried out to determine the recruited number of children selected randomly from both governmental and private primary and preparatory schools at El Mansoura educational administration, Dakahlia Governorate and Damietta governorate to participate in this study. The survey targets the normal students from both sexes.

They will be selected based on the following:

Inclusion criteria:

* All children will be age ranges from 10 to 12 years
* The BMI \<95th percentile (WHO, 2007)
* Smartphone addiction scale short version will be used to categorize the children to addicted group (score \> 32) (Kwon et al., 2013) .
* They will be cooperative and followed the instructions.

Exclusive criteria:

Children will be excluded from the study if they have:

* Neurological diseases.
* Respiratory disorders.
* Congenital deformities.
* Vision disorders not corrected by glasses.
* Children who participate in competitive sports.
* Obesity.

Eligibility criteria: Inclusion Criteria:

* All children will be age ranges from 10 to 12 years
* The BMI \<95th percentile (WHO, 2007)
* Smartphone addiction scale short version will be used to categorize the children to addicted group (score \> 32) (Kwon et al., 2013) .
* They will be cooperative and followed the instructions.

Exclusion Criteria:

* • Neurological diseases.

  * Respiratory disorders.
  * Congenital deformities.
  * Vision disorders not corrected by glasses.
  * Children who participate in competitive sports.
  * Obesity.

Primary outcomes:
measure: evaluation of pulmonary functions
timeFrame: baseline only
Secondary outcomes:
measure: evaluation of functional capacity
timeFrame: baseline only
Other outcomes:
measure: evaluation craniovertebral angle
timeFrame: baseline only
Locations:
city: Damietta
country: Egypt
facility: Governmental and Private Primary and Preparatory Schools
Study officials:
affiliation: Cairo University
name: yasmine eletreby
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06154161: Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis
Official title: Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Protein-Energy Malnutrition
Keywords: peritoneal dialysis
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 6-month prospective interventional clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a 6-month prospective interventional clinical trial designed to evaluate the impact of whey protein isolate oral supplement on protein status. Differences in protein status will be evaluated with review of the medical chart from standard of care monthly blood collection for serum albumin, total protein, and normalized protein catabolic rate (nPCR) as detected by serum urea nitrogen. Mid-arm circumference and weight will be measured to ensure no significant changes. Quality of life will be measured to detect if the addition of protein aided in overall quality of life. There will be a 3-month recruitment period prior to the start of the trial to ensure the potential participants are familiarized with the clinical trial. After the recruitment period has finished, eligible participants will sign the consent form in order to participate in the study. At this point, participants will be provided the supplements for the month and instructed with the amount of water and how to mix with the provided measuring and drinking cup.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* diagnosed with stage 5 Chronic Kidney Disease for at least 3 months prior to the starting date of the trial
* on peritoneal dialysis at least three months prior to the starting date of the trial
* can provide signed informed consent
* have no dietary restriction
* no food allergies
* no chewing/swallowing difficulties.

Exclusion Criteria:

* not meeting the above
* pregnant/lactating as either self-reported or determined by the medical director

  * Chronic Kidney Disease patient stages 1-4.
  * Chronic Kidney Disease patient undergoing hemodialysis.
* use of other protein supplement

Primary outcomes:
measure: Serum albumin
timeFrame: up to 6 months of the study
Secondary outcomes:
measure: Total protein
timeFrame: up to 6 months of the study
measure: normalized protein catabolic rate (nPCR)
timeFrame: up to 6 months of the study
measure: mid-arm muscle circumference
timeFrame: up to 6 months of the study
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Gainesville
country: United States
facility: UF Health Dialysis Center
state: Florida
Study officials:
affiliation: University of Florida
name: Jeanette M Andrade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00642161: New Version Pulmicort Turbuhaler USA Children
Official title: A Placebo-controlled Comparison of the Efficacy, Safety and Pharmacokinetics of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Children and Adolescents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Pulmicort
Children
Paediatrics
budesonide
Flexhaler
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 430
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.


Eligibility criteria: Inclusion Criteria:

* Male or females aged 6 to 17 with a diagnosis of asthma for at least 3 months. Have used inhaled corticosteroids for no more than one month before entering the study or none at all.
* A forced expiratory volume (FEV1) in 1 second of 75% to 90% of predicted normal for those aged 6 to 11 and 60% to 90% for those aged 12 to 17 years.
* Airway reversibility of at least 12% , use of orally inhaled corticosteroids for no more than one month immediately before entering the study or none at all.

Exclusion Criteria:

* Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
* Use of steroid tablets or injections during the month prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
* Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to Visit 1. Must not smoke or have smoked.

Primary outcomes:
measure: Change from Baseline in % predicted Forced Expiratory Volume in 1 second
timeFrame: Week 2, 4 and 8, then at week 12
Secondary outcomes:
measure: Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate
timeFrame: Week 2, 4 and 8, then at week 12
measure: Incidence of Adverse Events
timeFrame: Week 2, 4 and 8, then at week 12
measure: Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration
timeFrame: 6 or 12 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca employee
name: Bertil Andersson
role: STUDY_DIRECTOR
affiliation: AstraZeneca employee
name: Lars-Göran Carlsson
role: STUDY_DIRECTOR
References:
Clinical trial NCT06645561: Radiological Dating of Child Fractures Before One Year
Official title: Radiological Dating of Child Fractures Before One Year
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 99
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 99 radiographs of infants under one year of age with long bone fractures of known date were studied.

Brief summary: The aim of this study was to use, in a precise manner, defined radiographic semiological criteria to determine an analytical methodology to facilitate the dating of long bone fractures of infants under one year of age. A total of 99 radiographs of infants under one year of age with long bone fractures of known date were studied. Four dating groups were established on the basis of data in the literature, with the aim of developing predictive models based on well-defined semiological criteria, in order to construct a simplified dating decision tree.


Eligibility criteria: Inclusion Criteria:

* had X-rays taken at the University Paediatric Hospital for the diagnosis and/or follow-up of a fracture of the long bones of the limbs (tibia, femur, fibula, radius, humerus and/or ulna)

Exclusion Criteria:

* child maltreatment,
* chronic illnesses

Primary outcomes:
measure: Dating fracture
timeFrame: between 2011 and 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Fondation Lenval
Study officials:
References:
Clinical trial NCT02070861: Non-invasive Evaluation of Volume Status Using Exhaled Carbon Dioxide and Pulse Contour Analysis
Official title: Non-invasive Volume Evaluation With Exhaled Carbon Dioxide and Pulse Contour Analysis (Nexfin)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Changes in Cardiac Output
Keywords: Cardiac output
Exhaled CO2
Nexfin
Esophageal Doppler
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Norwegian Air Ambulance Foundation
First posted: 2014-02-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators hypothesize that changes in blood circulation can be reflected by exhaled CO2 provided CO2-production in the tissues and ventilation from the lungs are stable. The investigators want to explore changes in cardiac output (the amount of blood being pumped out of the heart each minute) in patients using different devices: an esophagus ultrasound device measuring cardiac output, a finger cuff measuring blood pressure and cardiac output, and exhaled carbondioxide in the patients' breath measured by the ventilator.

The investigators investigate patients after bypass surgery or heart valve replacement, and induce changes in cardiac output with passive leg raise or ventricular pacing.

Detailed description: Measurements with the finger cuff (pulse contour analyses) were aborted due to technical difficulties.

Eligibility criteria: Inclusion Criteria:

* Persons 18 years or older scheduled to undergo arteriocoranary bypass surgery or aortic valve replacement.

Exclusion Criteria:

* Esophageal pathology, EF \<40%

Primary outcomes:
measure: Changes in cardiac output
timeFrame: 5 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål
Study officials:
affiliation: Oslo University Hospital
name: Leiv Arne Rosseland, MD, PhD
role: STUDY_CHAIR
References:
citation: Hoff IE, Hoiseth LO, Kirkeboen KA, Landsverk SA. Volumetric and End-Tidal Capnography for the Detection of Cardiac Output Changes in Mechanically Ventilated Patients Early after Open Heart Surgery. Crit Care Res Pract. 2019 May 30;2019:6393649. doi: 10.1155/2019/6393649. eCollection 2019.