louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05210504: Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3
Official title: Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: lysine
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to assess the effect and breakdown of lysine administration, specifically examining whether it leads to increased plasma 2-AAA in healthy humans.

Detailed description: The purpose of this study is to investigate a novel biomarker, α-aminoadipic acid (2-AAA), which may influence the risk of diabetes. 2-AAA has been identified as a novel predictor of diabetes development in humans, identifying at-risk individuals before any detectable glucose abnormalities. 2-AAA is a naturally occurring metabolite in the body, and it has no known adverse effects at normal physiological levels. 2-AAA is generated in the body from the breakdown of lysine. Lysine is one of the twenty essential amino acids, meaning that it is essential for human function, but that our body cannot manufacture it. Thus, it is acquired from dietary sources (such as meat, eggs, soybeans and legumes), with a recommended daily intake of 30 mg/kg/day. Amino acids are the building blocks of proteins, which are what allow our cells, organs and body to maintain structure and function. The investigators are interested in whether 2-AAA is increased in the body after consumption of lysine.

Eligibility criteria: Inclusion Criteria:

-Prior participant in 2-AAA Dietary study.

Exclusion Criteria:

* Newly diagnosed disease, including cardiovascular, renal, liver disease, or Diabetes mellitus.
* Individuals who are pregnant or lactating.
* Inability to provide written or electronic informed consent.
* Inability to fast for 8 hours.

Primary outcomes:
measure: Change in Level of 13C 2-AAA in Plasma
timeFrame: Baseline to 6 Hours post-lysine administration
measure: Change in Level of 2-AAA in Urine
timeFrame: Baseline to 6 Hours post-lysine administration
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jane Ferguson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01060904: A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma
Official title: A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Disease, Hodgkin
Keywords: Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Disease, Hodgkin
Hematologic Diseases
Immunotherapy
Lymphoma
monomethyl auristatin E
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2010-02-02
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.


Eligibility criteria: Inclusion Criteria:

* Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
* Measurable disease of at least 1.5 cm
* Eastern Cooperative Oncology Group performance status \<3

Exclusion Criteria:

* History of another primary malignancy that has not been in remission for at least 3 years
* Known cerebral/meningeal disease

Primary outcomes:
measure: Incidence of adverse events and laboratory abnormalities
timeFrame: Through 1 month after last dose
Secondary outcomes:
measure: Brentuximab vedotin concentration in blood
timeFrame: Through 1 month after last dose
measure: Antitherapeutic antibodies in blood
timeFrame: Through 1 month after last dose
measure: Best clinical response
timeFrame: Through 1 month after last dose
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina
state: North Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Centre
state: British Columbia
Study officials:
affiliation: Seagen Inc.
name: Naomi Hunder, MD
role: STUDY_DIRECTOR
References:
citation: Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.
Clinical trial NCT02474004: Gait Analysis Meniscal Repair
Official title: 3D-gait Analysis in Patients With Medial Meniscus Repair vs. Partial Meniscectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lesion of the Medial Meniscus
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In the past it was shown, that medial partial meniscectomy (MPM) leads to an increase of the knee adduction moment (KAM) during walking. Other researches found out that an increase of the KAM is an important factor contributing to degeneration joint disease of the knee (osteoarthritis). Today, medial menicus repair (MMR) is favoured by many knee surgeons, because preserving as much of the meniscus as possible is assumed to delay degenerative joint disease.

The investigators hypothesize significant differences in knee adduction moments between patients treated with partial medial meniscectomy vs. patients treated with medial meniscus repair (hypothesis 1; major hypothesis). Additionally, it is hypothesized that: the mentioned groups differ with respect to other kinetic and kinematic key parameters of gait (hypothesis 2) and that the knee adduction moment correlates with the clinical outcome as determined by a typical knee score (hypothesis 3).


Eligibility criteria: Inclusion Criteria: patients with traumatic medial meniscus lesions scheduled for meniscal repair or resection

Exclusion Criteria:

* previous or current diseases of the back and the other joints of the lower limbs
* any form of inflammatory arthritis
* diabetes
* neurological disorders
* other conditions that may affect gait

Primary outcomes:
measure: knee adduction moment [Nm/kg]
timeFrame: once after 6 months
Secondary outcomes:
measure: set of kinetic, kinematic and temporospatial gait parameters
timeFrame: once after 6 months
Other outcomes:
measure: KOOS
timeFrame: 6 months post
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Medical University, Dept. Orthop. Surgery
state: Tyrol
city: Innsbruck
country: Austria
facility: Sportsclinic Austria
state: Tyrol
Study officials:
References:
Clinical trial NCT03255304: Influence of Priming on Goal-directed and Cue-dependent Behavior
Official title: Influence of Priming on Goal-directed and Cue-dependent Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Habits
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 222
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The current proposal aims to investigate implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.

Detailed description: Food choice and intake is a daily and throughout normal subject. However, for more and more people eating habits and the question of food choice are of increasing interest and in several cases even a problem. The prevalence of obesity has tripled in the last decades and it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail on the long run, also because people fall back into former unhealthy eating habits. Various factors influence our daily food choice, not all of which are apparent to ourselves. Thus, food choice might be goal-directed and therefore conscious and reflective, yet in other circumstances the choice to eat something specific might be based on cue dependent processes which are automatic and thus difficult to control. Since a change in eating-behavior and long-lasting weight loss is most problematic to achieve, the current proposal aims to investigate implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* currently dieting
* intolerance to provided food
* cognitive impairment

Primary outcomes:
measure: behavior
timeFrame: pre and post priming (directly before and directly after a 5 minutes priming paradigm)
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen
Study officials:
References:
Clinical trial NCT02396004: NIRS in PDA VLBW Infants
Official title: Near-Infrared Red Spectroscopy (NIRS) to Measure Cerebral Perfusion During and After Patent Ductus Arteriosus (PDA) Treatment in Very Low Birth Weight (VLBW) Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PDA
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 30
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VLBW (defined as birthweight less than 1500g) infants with hemodynamically significant PDA (patent ductus arteriosus) requiring treatment, either medical or surgical

Brief summary: Aim of study:

To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population.

Study population/inclusion criteria:

VLBW newborn babies with hemodynamically significant PDA by echocardiography.

Exclusion criteria:

Major malformations Moribund patients

Detailed description: Aim of study:

To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population.

Study population/inclusion criteria:

VLBW newborn babies with hemodynamically significant PDA by echocardiography.

Exclusion criteria:

Major malformations Moribund patients

Protocol:

Consent will be obtained from parents of eligible newborns before treatment of hemodynamic significant PDA. To attach cerebral and renal oximeter by NIRS to these VLBW infants with PDAs for until 24 hours post closure of PDA. Doppler ultrasound will be performed on anterior cerebral artery (ACA) and/or middle cerebral artery (MCA) artery and/or renal artery(RA) before PDA treatment and/or 24hours after PDA closure.This study aims to use one of the more popular neonatal/paediatrics NIRS machine, which is the INVOS cerebral/somatic oximeter

The same patient will hence form its own control after treatment. Echocardiographic follow-up or clinical assessment for closure of the PDA will be performed 24-48 hours after the course of medication or surgical closure.

Eligibility criteria: Inclusion Criteria:

* VLBW infants with hemodynamically significant PDA by echocardiography

Exclusion Criteria:

* Major malformation
* Moribund

Primary outcomes:
measure: cerebral oximetry
timeFrame: 2 years
Secondary outcomes:
measure: renal oximetry
timeFrame: 2 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Woei Bing Poon, MRCPCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01929304: Difficult Intravenous Access Perception: Difficult IV Access - Assessment of Patient Understanding
Official title: Assessment of Patient Understanding and Preference of Rescue Venous Access When Shown a Narrated Video Vignette Versus Traditional Paper Information Sheet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Understanding Emergency Room Procedures
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-08-27
Enrollment: 1180
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible for enrollment would be any hemodynamically stable adult 18 years of age or older who is a HUP Emergency Department patient, able to provide informed consent, without history of difficult intravenous access, and able to speak, read, hear, and speak English fluently.

Brief summary: Aim: Patient Perception: This aim broadly intends to use traditional script versus a brief video education vignette to determine understanding and preferences among general emergency department patients of rescue access techniques. A challenge of emergency care is providing patient education surrounding procedures in a standardized and patient-oriented manner. This data would provide insight on a patient's understanding of the risks and benefits of rescue access, assess patient preference, and potentially influence what rescue technique is employed in the future. This information may also give us insight onto why DIVA patients might refuse randomization.


Eligibility criteria: Inclusion Criteria:

* greater than or equal to 18 years of age
* fluent in English
* hemodynamically stable emergency department patient

Exclusion Criteria:

* history of or current status of difficult intravenous access

Primary outcomes:
measure: Patient Understanding
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01743404: Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
Official title: Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carotid Atherosclerosis
Keywords: atherosclerosis
inflammation
intima-media thickness
Lead sponsor: Institute for Atherosclerosis Research, Russia
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 300
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the anti-atherosclerotic effect of long-term anti-inflammatory therapy (Inflaminat) in asymptomatic participants with subclinical atherosclerosis of carotid arteries.


Eligibility criteria: Inclusion Criteria:

* Men aged 40 to 70 years
* Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1000-2000 mcm)
* Arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm Hg, diastolic blood pressure \<90 mm Hg)
* Absence of chronic diseases demanding permanent drug administration (more than 2 month per year)

Exclusion Criteria:

* Personal history of stroke or transient ischemic attacks
* Chronic diseases demanding drug administration more than during 2 month per year
* Individual intolerance of Inflaminat or appearance of side effects

Primary outcomes:
measure: B-mode ultrasound of carotid arteries
timeFrame: up to 2 years
Secondary outcomes:
measure: Measure of serum atherogenicity
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Atherosclerosis Research
Study officials:
References:
Clinical trial NCT05675904: Textbook Outcome in Colon Carcinoma
Official title: Textbook Outcome in Colon Carcinoma: Implications for Overall Survival and Disease-free Survival.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outcome Assessment
Cancer of Colon
Lead sponsor: Hospital General Universitario de Alicante
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective colon cancer resection with confirmed histological diagnosis

Brief summary: BACKGROUND:

Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for colon cancer.

MATERIAL AND METHODS:

Retrospective study of all patients undergoing scheduled colon cancer surgery at a Spanish university hospital from September 2012 to August 2016. Patients with rectal cancer were excluded. The variables included in the definition of TO were: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days.

The main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled colon cancer resection at the Doctor Balmis General University Hospital in Alicante, Spain. The investigators assess the relationship between TO and overall and disease-free survival, and analyse the indicators included in the definition of TO in colon cancer surgery in order to establish recommendations for its standardization.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective colon cancer resection with confirmed histological diagnosis were eligible for the study

Exclusion Criteria:

* Age under 18 years
* Emergency surgery
* Resections of the rectum or resections for pathologies other than cancer
* Follow-up of less than two years (with the exception of patients who died)

Primary outcomes:
measure: Textbook Outcome
timeFrame: September 2012- August 2016
measure: Overall survival
timeFrame: From surgery to 160 months
measure: disease-free survival
timeFrame: From surgery to 160 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
Study officials:
References:
Clinical trial NCT00746304: Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
Official title: Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esotropia
Keywords: botulinum
esotropia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 164
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 373 patients with strabismus were treated with botulinum toxin injection by a single surgeon (AH Wang) at the Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan from 1992 to 2005.

Brief summary: To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia.

Detailed description: Participants: 164 patients with infantile esotropia and 89 patients with acquired esotropia.

Methods: Patients were injected with botulinum toxin into two medial rectus muscles and followed from 1992 to 2005. Patients were evaluated at 1 week, 2, 6 and 12 months, and then yearly post-injection.

Main Outcome Measures: Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.

Eligibility criteria: Inclusion Criteria:

* infantile esotropia and acquired esotropia

Exclusion Criteria:

* exotropia, high AC/A ratio accommodative esotropia, patients with neurological deficit including cerebral palsy, Down syndrome and mental retardation, and ocular anomalies including retinopathy of prematurity. Patients lost to follow-up at 6 months or less after the last injection were also excluded.

Primary outcomes:
measure: Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.
timeFrame: Before treatment, weekly after the treatment, and monthly after motor alignment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Tzu-Hsun Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References: