louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00887692: Comparison of Set-up Reproducibility Between Prone and Supine Intensity Modulated Radiotherapy (IMRT) for the Adjuvant Treatment of Breast Carcinoma After Lumpectomy
Official title: Comparison of Set-up Reproducibility Between Prone and Supine Intensity Modulated Radiotherapy (IMRT) for the Adjuvant Treatment of Breast Carcinoma After Lumpectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2009-04-24
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 10 patients will be treated alternating daily between prone and supine position for breast radiotherapy to compare set-up accuracy. Prone treatment will be given on the odds days and supine treatment on the even days.


Eligibility criteria: Inclusion Criteria:

* female patients
* multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer
* minimum 18 years
* informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

* mastectomy
* need for axillary irradiation
* bilateral breast irradiation
* previous irradiation at the same time
* pregnant or breastfeeding
* mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
* patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Primary outcomes:
measure: Random set-up error
timeFrame: daily during radiotherapy
Secondary outcomes:
measure: Systemic set-up error
timeFrame: daily during radiotherapy
measure: Respiration-related motion amplitude
measure: time of treatment delivery
timeFrame: daily during radiotherapy
measure: Dose-volume parameters
timeFrame: of planning
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05609292: Testing A Visual Thermometer in Newborns and Young Infants
Official title: Testing A Visual Thermometer in Newborns and Young Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperthermia
Hypothermia
Keywords: temperature monitoring
liquid crystal thermometer
hypothermia
hyperthermia
LCTD
infant temperature
infant hyperthermia
infant hypothermia
neonate hyperthermia
neonate hypothermia
neonate temperature
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants between the age of 0-6months

Brief summary: "Severe neonatal jaundice and acute bilirubin encephalopathy are a major cause of death and disability among newborns in LMICs. Filtered sunlight phototherapy (FSPT) was developed, tested and shown to be safe and efficacious in the treatment of jaundice, because effective electric-powered conventional phototherapy is often unavailable10,11. However, FSPT currently requires at least hourly temperature monitoring by healthcare providers (HCPs) because infants receiving FSPT are prone to both hypothermia and hyperthermia.

20 years ago, a liquid crystal thermometer, ThermospotTM (Maternova, Providence, RI) was developed primarily for use in LMICs. It was designed to detect hypothermia and is most sensitive in cold infants and not as sensitive as needed for detecting hyperthermia or fever. The purpose of this pilot study is to determine the accuracy and useability of this LCTD for a wider spectrum of temperatures when used in a large group of infants in a high-income country. If the device performs well in this study, we plan to study it in a low- and middle-income country in Africa."


Eligibility criteria: Inclusion Criteria:

* Infants 0-6 months (\<7 months) presenting to Masonic Emergency Room or inpatient ward, their parent or caregiver who provide verbal consent in English or through a medical interpreter.

Exclusion Criteria:

* Any infant undergoing active resuscitation
* any infant for whom physician deems study enrollment would interfere with their care
* any infant whose parents or caregiver decline enrollment
* any nurse or other healthcare provider who declines participation
* Parents who do not understand English, and do not have a medical interpreter at the bedside.

Primary outcomes:
measure: Accuracy of the liquid crystal thermometer with measuring a temperature
timeFrame: baseline
measure: Parents/Caregivers and Healthcare provider accuracy in evaluating the infant temperature
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Tina Slusher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06948292: Role of QRX-3 in Chronic Kidney Disease Patients in Outpatients Clinics
Official title: Role of QRX-3 a Novel NAD Modulator in Ambulatory Chronic Kidney Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease Stages 3-5
Diabetic Kidney Disease
Hypertensive Kidney Disease
Keywords: CKD
estimated GFR (eGFR)
proteinuria
random urine protein creatinine ratio
creatinine change
Lead sponsor: Neukidney Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-29
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: QRX-3 added to intervention group in addition to standard therapy
Primary purpose: TREATMENT

Brief summary: QRX-3, a new drug that stabilized the kidney renal tubular cell and increase the activity of NAD within the kidney cells, is expected to improve baseline renal function when given over a period of one year . The result of the change in renal function will be compared to control without the medication during that same period .


Eligibility criteria: Inclusion Criteria:

* Patient with Chronic kidney disease stage 3-5
* Estimated Glomerular function by MDRD of less than 60mls/min
* Patients with declining renal function ( as measured by eGFR by MDRD )
* Rate of decline of eGFR over the last one year of less than 20%
* Negative Serology markers for CKD etiology
* Provider perceived adherence to study follow- up

Exclusion Criteria:

* Rapid rate of decline in kidney function of \> 10 % over 3 months
* Symptomatic renal failure
* Presence of any suspected Acute renal failure superimposed
* Presence of cast , hematuria, or abnormal urinalysis outside of simple UTI
* No known reversible cause of renal decline

Primary outcomes:
measure: daily change in glomerular filtration rate by creatinine in mls/min
timeFrame: 12 months
Secondary outcomes:
measure: change in proteinuria by mg/g
timeFrame: 12 months
Other outcomes:
Locations:
city: Pasedena
country: United States
facility: Neukidney Inc
state: Texas
Study officials:
References:
Clinical trial NCT00150592: Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
Official title: A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 182
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: The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.


Eligibility criteria: Inclusion Criteria:

* Subjects with a primary diagnosis of ADHD
* Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =\>4
* Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
* Subject weighs \> 55 lbs and is not morbidly overweight

Exclusion Criteria:

* Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
* Subject has a history of seizure disorder
* Subject has any specific cardiac condition or family history of significant cardiac condition
* Subject is pregnant, lactating or within six month post-partum

Primary outcomes:
measure: Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks
timeFrame: 6 weeks
measure: Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Kollins SH, Lopez FA, Vince BD, Turnbow JM, Farrand K, Lyne A, Wigal SB, Roth T. Psychomotor functioning and alertness with guanfacine extended release in subjects with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2011 Apr;21(2):111-20. doi: 10.1089/cap.2010.0064. Epub 2011 Apr 10.
Clinical trial NCT01324492: Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
Official title: A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Neuroendocrine Neoplasm
Keywords: phase Ib,
RAD001,
advanced pulmonary neuroendocrine tumor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed carcinoid tumors
* Newly diagnosed advanced carcinoid tumors or progressed after 1st line treatment is eligible

Exclusion Criteria:

* Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis(non-clinical symptoms with brain lesions is eligible)
* Received Cytotoxic chemotherapy, immunotherapy or radiotherapy prior to enrollment
* Patients with a concurrent malignancy, or history of prior malignancy within the past three years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer
* Prior therapy with RAD001 or other mTOR inhibitors (sirolimus, temsirolimus, everolimus)

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Adverse events, serious adverse events, laboratory results (Hematology, Serum Blood Chemistry, hepatitis tests, Standard urinalysis dipstick assessment, Coagulation Studies)or assessment of the incidence of pneumonitis
timeFrame: every 6 weeks
Secondary outcomes:
measure: Chest X-Ray,Triphasic CT scan or MRI of the chest, abdomen and cavitas pelvis evaluated by using RECIST criteria
timeFrame: 6 weeks
measure: Date and reason of death, or discontinuation from the study.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Changchun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Investigative Site
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01181492: Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery
Official title: Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Surgery
Keywords: gene polymorphism
CYP3A4
fentanyl
HPLC
Analgesics
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2010-08-13
Enrollment: 176
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 176 Chinese patients receiving elective lower abdominal surgery under general anesthesia

Brief summary: Purpose: This study aimed to investigate the impact of CYP3A4\*1G genetic polymorphism on metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176 patients receiving elective lower abdominal surgery under general anesthesia were recruited into this study. Genotyping of CYP3A4\*1G was carried out by direct sequencing. The plasma fentanyl concentration was detected 30 min after anesthesia induction by high performance liquid chromatography-ultraviolet ray (HPLC-UV). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24 h after operation. PCA fentanyl consumption and adverse effects were recorded during the first 24 h after surgery.


Eligibility criteria: Inclusion Criteria:

* Aged 20-65 years
* Anesthesiologists (ASA) physical status I or II;
* With ±20% of ideal body weight;
* Received PCA administration;
* Agreed to participate the research

Exclusion Criteria:

* History of chronic pain;
* Psychiatric diseases;
* Diabetes mellitus;
* Severe cardiovascular diseases;
* Kidney or liver diseases;
* Alcohol or drug abuse (according to the criteria of DSM-IV);
* Pregnancy or at lactation period;
* Consumed drugs (1week) or foods (3 days) known to inhibit or induce the expression of CYP3A4 enzymes prior to surgery;
* Refused PCA administration;
* Disagree to participate to the research

Primary outcomes:
measure: CYP3A4*1G Polymorphism
timeFrame: 48 hours after operation
Secondary outcomes:
measure: The Visual Analog Scale 24 Hours Postoperative
timeFrame: 24 hours after operation
measure: PCA Fentanyl Consumption
timeFrame: 24 h after surgery
Other outcomes:
Locations:
city: Wuhan,
country: China
facility: 1. Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Zhang Xianwei, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01223092: Study of Gene Associations and Infertility
Official title: Genes and Gene Polymorphisms Associated With Infertility: Utilization of DNA Characteristics to Better Understand Reproductive Competence
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Infertility
Keywords: IVF
infertility
DNA
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing infertility treamtnet

Brief summary: The purpose of this this study is to use DNA screening strategies to identify genes and localize genomic regions that are differentially expressed in patients with infertility to further understand the genetic basis for reproductive competence.

Detailed description: Experimental strategies seek to discover small variants in DNA sequences, which are associated with certain infertility parameters. The alleles being analyzed in in vitro fertilization (IVF) population are sought to be associated with functional differences in the expression of the gene product that are then mechanistically linked to infertility.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing fertility care

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of retrieved oocytes
timeFrame: 1 month
Secondary outcomes:
measure: Fertilization rate
timeFrame: 1 month
measure: Number of available embryos
timeFrame: 1 month
measure: Pregnancy rates
timeFrame: 1 year
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Jason Franasiak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patounakis G, Treff N, Tao X, Lonczak A, Scott RT Jr, Frattarelli JL. The p53 codon 72 single nucleotide polymorphism lacks a significant effect on implantation rate in fresh in vitro fertilization cycles: an analysis of 1,056 patients. Fertil Steril. 2009 Oct;92(4):1290-1296. doi: 10.1016/j.fertnstert.2008.07.1783. Epub 2008 Oct 17.
citation: Patounakis G, Bergh E, Forman EJ, Tao X, Lonczak A, Franasiak JM, Treff N, Scott RT Jr. Multiple thrombophilic single nucleotide polymorphisms lack a significant effect on outcomes in fresh IVF cycles: an analysis of 1717 patients. J Assist Reprod Genet. 2016 Jan;33(1):67-73. doi: 10.1007/s10815-015-0606-z. Epub 2015 Nov 6.
Clinical trial NCT03499392: Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.
Official title: Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Headache Disorder
Keywords: psychological factors
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The World Health Organization (WHO) ranks headache among the top 20 causes of disability in the world.

Primary headaches (with no known organic cause) account for 90% of these conditions. INSERM estimates that 15% of the general population is concerned. WHO estimates that 1.7-4% of the global adult population is affected by headache for at least 15 days a month. Headaches are disabling, for patients (pain, suffering, fatigue, unavailability ...) but also for society (socio-economic cost as frequent work stoppages and drug costs). They are a public health problem.

In 2002, the High Authority of Health published its recommendations for the diagnosis and management of migraine patients. In addition, the French Society for Migraine and Headache Studies updated these recommendations in 2013. They are focused on the medical management offered by doctors and pharmacists. However, the professionals in daily contact with the subjects know that the dimension psychic plays an important role in the etiology of headaches.

Detailed description: The review of the literature shows the keen interest and the need for this type of research to better understand the main psychological factors involved in primary headaches.

The current vagueness, the lack of knowledge regarding the aspects associated psychological and the lack of studies on the French population can be filled with this study which takes place at the University Hospital of Besançon.

Eligibility criteria: Inclusion Criteria:

* first consultation in neurology good general somatic state

Exclusion Criteria:

* Pregnancy History of psychiatric disorder

Primary outcomes:
measure: Number of headache attacks
timeFrame: Month 9
measure: Duration of each headache attack
timeFrame: Month 9
Secondary outcomes:
measure: Definition of patient's psychological profile
timeFrame: Month 9
Other outcomes:
Locations:
city: Besançon
country: France
facility: Belot
state: Doubs
Study officials:
References: