louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05033119: PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
Official title: PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hyperprolactinemia
Puberty Disorders
Metabolic Syndrome
Growth Disorders
Antipsychotics and Neuroleptics Toxicity
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: North Denmark Region
name: Central Denmark Region
name: Mental Health Services in the Capital Region, Denmark
First posted: 2021-09-02
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All outpatients aged 7-18 years receiving treatment with antipsychotics at the Department of Child and Adolescent Psychiatry, Aalborg University Hospital, the Department of Child and Adolescent Psychiatry, Aarhus University Hospital and at the Child and Adolescent Mental Health Center, Copenhagen University Hospital, Capital Region will be invited to participate in the study.

Brief summary: The objectives of this study are:

1. To determine the prevalence and degree of hyperprolactinemia in children and adolescents aged 7-18 years receiving antipsychotic medications
2. To determine the associations between serum-prolactin and sex hormones / metabolic biomarkers/ clinical symptoms in this population. If clinically relevant associations are found: To determine a potentially existing "no harm" serum-prolactin threshold
3. To determine associations between previous cumulative prolactin-exposure and current pubertal development / growth


Eligibility criteria: Inclusion Criteria:

* • In daily treatment with antipsychotic medication belonging to Anatomical Therapeutic Chemical (ATC) group N05A (except N05AN lithium) for a minimum duration of 3 months prior to inclusion

Exclusion Criteria:

* Eating Disorder
* Medical treatment to change sex
* Pregnancy or lactation

Primary outcomes:
measure: Prevalence of hyperprolactinemia
timeFrame: 2 years
Secondary outcomes:
measure: associations between serum-prolactin and sex hormones / metabolic biomarkers / clinical symptoms
timeFrame: 2 years
measure: associations between previous prolactin-exposure and current pubertal development / growth
timeFrame: 2 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Research Unit for Child and Adolescent Psychiatry, Aalborg University Hospital, Denmark
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Child and Adolescent Mental Health Center Capital Region, Denmark
Study officials:
affiliation: Research Unit for Child and Adolescent Psychiatry, Aalborg,
name: Ulla S Nielsen
role: STUDY_DIRECTOR
References:
Clinical trial NCT05063019: Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index
Official title: Adding Value of Magnetic Resonance Imaging and Magnetic Resonance Enterography for the Pre-operative Assessment of Imaging Peritoneal Cancer Index in Patients With Peritoneal Carcinomatosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperthermic Intraperitoneal Chemotherapy
Cytoreductive Surgery
Peritoneal Carcinomatosis
Keywords: Hyperthermic Intraperitoneal Chemotherapy
Cytoreductive Surgery
Peritoneal Cancer Index
Magnetic Resonance Enterography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 90
Sex: ALL
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: DIAGNOSTIC

Brief summary: This is a prospective observational study which will recruit 90 participants over a three-year period to investigate whether adding magnetic resonance imaging and enterography to routine computed tomography study can better predict the extend of peritoneal carcinomatosis over computed tomography alone.

Detailed description: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a new option for patients with peritoneal carcinomatosis and the effectiveness of HIPEC depends on the extend of disease. Currently, pre-operative imaging peritoneal cancer index (PCI) is used to predict the intraoperative tumor extend and completeness of cytoreduction. However, the investigators' previous study and literature review show that imaging PCI usually underestimated intraoperative PCI, resulting in subsequent Open-Close operation. The investigators hypothesize that magnetic resonance imaging (MRI) is a better predictor of the intra-operative PCI than computed tomography (CT), and MR Enterography can better represent tumor deposits in the small intestine. This study aims to test whether the addition of MRI and MR Enterography to CT study improves the prediction performance of the intraoperative PCI and completeness of optimal cytoreduction over CT alone.

Eligibility criteria: Inclusion Criteria:

* Patients with peritoneal carcinomatosis diagnosed by computed tomography
* Schedule for operation at our institute

Exclusion Criteria:

* Age \< 20 years old
* Renal function impairment or acute renal failure
* Contraindications for magnetic resonance imaging
* Primary tumor not origins from colorectal cancer, gastric cancer or ovarian cancer

Primary outcomes:
measure: Predicting intraoperative PCI scores for patients with peritoneal carcinomatosis, using MR Enterography and CT
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital, Chiayi, Taiwan
name: Chia-Ni Lin, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06286319: Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler"
Official title: A Single Center Pilot Study for Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler"
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lung Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of this feasibility study is to evaluate continuous temperature monitoring, oxygen (O2) concentration and ventilation with positive end expiratory pressure (PEEP) to keep lungs cooled at 4-8 degrees Celsius, with continuous O2 concentration of 100% and inflated with a PEEP of 8-10 during the entire cold ischemic period.

Detailed description: The Angel Lung Cooler is a lung preservation method for transplantation. The device has temperature and airway pressure sensors that assess the oxygen temperature in the airways to confirm during the entire preservation time that desired airway temperatures (between 8 and 10 oC) and mean airway pressure to keep the lungs inflated during transportation is optimized.

For the purposes of the trial, the Angel Cooler will be in the operating room at time of transplant when both of the lungs are explanted. The explanted lungs (those removed and not the donor lungs) will be connected to the cooler to determine inflation and temperature changes of the lungs. This procedure will take approximately 5 - 20 minutes. The lungs will then be disconnected from the cooler and then returned to the back table for transport to the Pathology department. As part of standard procedures, the lungs remain in the Operating room for a few hours before they are transported to the Pathology department.

Eligibility criteria: Inclusion Criteria:

* Age at least 18 years
* Subjects who have signed Universal Consent are eligible for participation.
* Subjects willing to sign the Universal Consent for the use of their lungs in this study.

Exclusion Criteria:

• Explanted lungs of those who have not signed the Universal Consent (UC) or who have declined participation in the UC will be excluded.

Primary outcomes:
measure: Proportion of Devices Deemed "Functional"
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Luis Angel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00923819: 4XL Study - Obesity Surgery in Adolescence
Official title: 4XL-Study - Obesity Surgery in Adolescence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Keywords: Adolescents
Gastric Bypass
Quality of Life
Mental Health
Lifestyle
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
Collaborators: name: The Hospital of Vestfold
First posted: 2009-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity is to determine whether surgical treatment gives more health benefits than standard conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a low complication rate.

Detailed description: The study has two intervention arms:

Experimental: Group A Surgery; laparoscopic gastric bypass

Active comparator: Group B Patients from Child Obesity Registry of Vestfold who get standard conservative treatment in a multidisiplinary team at Morbid Obesity Center.

All patients are referred to Morbid Obesity Center from other hospitals or general practionairs in Norway. The procedure will take place at the Vestfold Hospital Trust The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month at the Morbid Obesity Center. Total follow-up time is ten years.

Eligibility criteria: Inclusion Criteria:

* Between 13 and 18 years of age at inclusion
* Tanner stage 4-5
* BMI \> 40 kg/m2 or BMI \> 35 with at least one comorbidity (type 2-diabetes, obstructive sleep apnea, serious hypertension or cerebral pseudotumor)
* At least one year multidisciplinary treatment completed

Exclusion Criteria:

* Tanner stage \< 4
* Substantial risk for lack of compliance
* Obesity syndrome (e.g., Prader Willi syndrome)
* Obesity related to brain damage
* Serious general disease
* Monogenic obesity

Primary outcomes:
measure: BMI and weight loss
timeFrame: Baseline, Year 1, 2, 5, 10
Secondary outcomes:
measure: Quality of Life (KINDL)
timeFrame: 10 years
measure: Eating Disorders (Child Eating Behavior Questionnaire)
timeFrame: 10 years
measure: Mental Health (Development and Well-Being Assessment, DAWBA)
timeFrame: 10 years
measure: Self-Esteem (Rosenberg Self-Esteem scale)
timeFrame: 10 years
measure: Surgical and Medical Complications
timeFrame: 10 years
measure: Blood sample results
timeFrame: 10 years
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority
Study officials:
affiliation: Vestfold Hospital Trust/The Hospital of Vestfold
name: Samira Lekhal, PhD,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vestfold Hospital Trust/The Hospital of Vestfold
name: Jøran Hjelmesæth, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04427319: The Efficacy β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists
Official title: A Randomised Double-blind Clinical Trial to Analyse the Efficacy of Short-term β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supplementation
Cyclists
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-blind, placebo-controlled, randomised, with two arms (product and placebo) unicentric clinical trial to analyse the efficacy on physical performance parameters of a product designed for sport during a lapse of two weeks (7 days).

Detailed description: After recruitment, subject will be randomised and allocated to one group of the 2 study arms: treatment group or control group (placebo).

A simple randomisation will be performed using software by a random number generator, and assigned to participants.

Eligibility criteria: Inclusion Criteria:

* Not respecting rest the day before physical tests.
* Not being in a fasted state (at least 2 h from last meal).
* Having consumed stimulants acutely before the trial, or under drug treatment affecting perceived effort of the trial.
* Not being available to perform every trial on the same conditions at the same time of the day.
* Not sticking to the same diet, 24 h before each trial.

Exclusion Criteria:

* Adverse event
* Protocol violation
* Lost to follow-up
* Allergy to any of the components of the treatment or placebo product. This includes allergy to β-alanine, wheat, soy, nuts (including peanuts), sesame and its byproducts.

Primary outcomes:
measure: Fatigue
timeFrame: Change of baseline rate of perceived exertion at seven days
Secondary outcomes:
measure: Performance outcomes
timeFrame: It will be measured on two different occasions. Day one and seven days later.
measure: Paresthesia test
timeFrame: It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after.
measure: Microcapillary blood
timeFrame: It will be measured on two different occasions. Day one and seven days later.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References:
Clinical trial NCT02369419: Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy
Official title: Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: frailty
Heart failure
cardiac resynchronization therapy
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
name: University Hospital, Rouen
name: University Hospital, Caen
First posted: 2015-02-24
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of \> 70 years age, selected for CRT according to the ESC 2013 guidelines

Brief summary: Background: The cardiac resynchronization therapy (CRT) has been shown to improve symptoms and outcome of patients with congestive heart failure (HF), and depressed left ventricular ejection fraction (LVEF \< 35 %). The rate of non-responders to CRT is estimated at 30 %. Yet, the impact of frailty on the response to CRT has not been studied, until now.

Purpose : To assess the impact of frailty in the elderly, on the response to CRT.

Detailed description: Methods : Frailty is evaluated before implant ,and defined as \<14/17 points using the ONCODAGE score, in 150 patients of \> 70 years age, selected for CRT according to the ESC 2013 guidelines. The response to CRT, estimated at 9 months, is defined as an improvement of at least 5 % of the LVEF and the absence of HF hospitalization or cardiovascular death.

Eligibility criteria: Inclusion Criteria:

* Patients of \> 70 years age,
* Selected for CRT according to the ESC 2013 guidelines

Exclusion Criteria:

* patients included in other clinical trial which can interfere with the results of this one

Primary outcomes:
measure: non response on CRT
timeFrame: 9 months
Secondary outcomes:
measure: seric albumin
timeFrame: 9 months
measure: seric gammaglutamyltranferase
timeFrame: 9 months
measure: mortality
timeFrame: 9 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU; Service de Cardiologie, Rythmologie et Stimulation cardiaque
Study officials:
affiliation: CHU Amiens
name: Maciej KUBALA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kubala M, Guedon-Moreau L, Anselme F, Klug D, Bertaina G, Traulle S, Buiciuc O, Savoure A, Diouf M, Hermida JS. Utility of Frailty Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1523-1533. doi: 10.1016/j.jacep.2017.06.012. Epub 2017 Sep 13.
Clinical trial NCT04868019: Role of Fenofibrate in Indirect Neonatal Hyperbilirubinemia: a Randomized Control Trial
Official title: Fenofibrate in Indirect Neonatal Hyperbilirubinemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperbilirubinemia, Neonatal
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Groups A will receive Solution A i.e. Fenofibrate suspension is prepared by dissolving 200 mg capsule in 10 ml distilled water and given as a single dose of 10mg/kg (0.5 ml/kg) and Group B will receive solution B i.e. 0.5ml/ kg normal saline as a placebo. Both groups will receive LED phototherapy under standard conditions. The serum bilirubin level will be noted at the time of admission and then at 12hr, 24hr, and 48 hours of treatment.
Primary purpose: TREATMENT

Brief summary: Fenofibrate accelerates bilirubin conjugation and excretion, decreasing the side effects of prolonged unconjugated hyperbilirubinemia in neonates. It also reduces the duration of phototherapy and thus the duration of stay in the hospital. This research is carried out to improve standard protocol for the management of neonatal hyperbilirubinemia in the local settings.

Detailed description: Complete history and examination will be carried out while patients will be screened for enrollment. After taking informed consent, eligible patients will be selected and divided into two groups A and B by lottery method. Demographics like name, age (hours), gender, birth weight, and gestational age will be noted. Solutions will be prepared in the required strengths and labeled accordingly. Groups A will receive Solution A i.e. Fenofibrate suspension is prepared by dissolving 200 mg capsule in 10 ml distilled water and given as a single dose of 10mg/kg (0.5 ml/kg) and Group B will receive solution B i.e. 0.5ml/ kg normal saline as a placebo. Both groups will receive LED phototherapy under standard conditions. The serum bilirubin level will be noted at the time of admission and then at 12hr, 24hr, and 48 hours of treatment. All this information will be recorded on proforma.

Eligibility criteria: INCLUSION CRITERIA:

* Gestational age ≥ 35 weeks
* Birth weight ≥ 2 kg
* Age: 2-7 days of life
* Total serum bilirubin level ≥15mg/dl and ≤20 mg/dl

EXCLUSION CRITERIA:

* Neonates with total bilirubin \>20mg/dl
* Conjugated bilirubin level greater than 15% of total serum bilirubin
* Maternal hyperbilirubinemia (on medical record)
* Babies with congenital anomalies (on clinical examination)
* Those not consenting to participate in the study

Primary outcomes:
measure: Duration of phototherapy
timeFrame: 6 months
Secondary outcomes:
measure: Serum bilirubin level
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01406119: An Extension Study of ABT-806 in Subjects With Advanced Solid Tumors
Official title: An Extension Study of ABT-806 for Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an extension study of ABT-806 for subjects with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Subject has completed a prior study utilizing ABT-806 or 111ln ABT-806 (ABT 806i) and the Investigator believes that continued treatment with ABT-806 is in the best interest of the subject.
* Women of childbearing potential and men must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for a period of 3 months. Female subjects considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year.
* Subject is capable of understanding and complying with parameters as outlined in the protocol and the subject or the subject's legal acceptable representative is able to sign informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any or study-specific procedures.

Exclusion Criteria:

* Subject discontinued ABT-806 or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).
* Subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
* Subject is a lactating or pregnant female.

Primary outcomes:
measure: Safety (Number of subjects with adverse events)
timeFrame: At each treatment visit (every other week throughout the study or up to 51 weeks)
measure: Pharmacokinetic profile (assay for ABT-806)
timeFrame: Every 8 weeks starting at Week 9 throughout the study or up to 51 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 58883
state: Maryland
city: Boston
country: United States
facility: Site Reference ID/Investigator# 58882
state: Massachusetts
city: Heidelberg
country: Australia
facility: Site Reference ID/Investigator# 60619
city: Herston
country: Australia
facility: Site Reference ID/Investigator# 63845
Study officials:
affiliation: AbbVie
name: Christopher Ocampo, MD
role: STUDY_DIRECTOR
References: