louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00199173: Comparing Hepatic Intra-arterial Injection of Yttrium-90 Microspheres Versus Fluorouracil (5FU) in Colorectal Cancer Metastatic to the Liver Only
Official title: Comparison Hepatic Intra-arterial Injection of Yttrium-90 Versus 5FU in Colorectal Cancer Metastatic to the Liver Only
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasm
Secondary Malignant Neoplasm of Liver
Keywords: colorectal cancer
liver metastasis
intraarterial hepatic injection
yttrium loaded microspheres
colorectal neoplasm metastatic to the liver
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase III trial comparing hepatic intra-arterial injection of Yttrium-90 microspheres (selective internal radiation \[SIR\] spheres) versus infusional intravenous (IV) 5FU in colorectal cancer metastatic to the liver only and refractory to standard IV chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically proven colorectal adenocarcinoma, metastatic to the liver only.
* Failure of prior chemotherapy for advanced colorectal cancer.
* Adequate laboratory values of hematologic, renal and liver function
* World Health Organization (WHO) performance status (PS) \<= 2
* Written consent

Exclusion Criteria:

* Pregnant or lactating patients
* Other tumor type than adenocarcinoma (leiomyosarcoma; lymphoma).
* Patients with cirrhosis or other chronic liver disease
* Thrombosis of the hepatic main artery of the portal vein
* Lung shunting \> 20% as determined by nuclear medicine breakthrough scan
* Patients with serum bilirubin \> 1.0 x upper limit of normal (ULN) or with AST and/or ALT and/or alkaline phosphatase \> 5 x ULN
* Patients with concurrent or within 4 week period administration of any other experimental drugs.
* Other serious illness or medical conditions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Jules Bordet Institute
Study officials:
affiliation: Jules Bordet Institute
name: Alain Hendlisz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01729273: Vascular Health and Exercise Performance of Overweight Children
Official title: Vascular Health and Exercise Performance of Overweight Children in 12 Weeks Using Skype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess exercise performance in 20 healthy children 10-19 years of age with a body mass index greater than 85th percentile and to evaluate the effect of dietary and exercise intervention over 12 weeks.

Detailed description: Our hypothesis is that the vascular health in these children will improve at the end of intervention. The results of this study will help us in our long-term objective of improving vascular health of children with congenital/acquired heart disease, a group particularly at risk for premature atherosclerosis.

Eligibility criteria: Inclusion Criteria:

* 10-19 years old
* Overweight (BMI \> 85 percentile)
* Interested in a 12 week ¬home exercise \& nutrition program
* Have computer \& internet access
* Can come to Lucile Packard Children's Hospital at Stanford for a 3-hour test at the start \& end of the study (so only twice!)
* Are able to come to testing after fasting overnight
* Do not smoke
* Do not take any medications

Exclusion Criteria:

* non-overweight adolescents

Primary outcomes:
measure: Vascular Health
timeFrame: Beginning of 12th week and end of 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
Study officials:
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
name: Seda Tierney, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
name: Chau N Vu, BS
role: STUDY_DIRECTOR
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
name: Katie Jo Buccola
role: STUDY_CHAIR
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
name: Jeffrey Kazmucha
role: STUDY_CHAIR
affiliation: Stanford Prevention Research Center
name: Laurie Steinberg
role: STUDY_CHAIR
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
name: Olga Ogareva
role: STUDY_CHAIR
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
name: Inger Olson, MD
role: STUDY_CHAIR
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
name: Chinyelu Nwobu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00333073: Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence
Official title: Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence
Bulkamid
Lead sponsor: Contura
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 125
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: To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Symptomatic stress or mixed urinary incontinence for at least 12 months
* Having at least 1 incontinence episode per day over three days

Exclusion Criteria:

* Regular or intermittent users of an urethral catheter
* Pregnant women
* Suffer from severe allergies or anaphylaxis
* Suffer from autoimmune diseases or any unstable or sever cardio-vascular disease
* History of any cancer within the last 5 years
* Previous surgery for the treatment of urinary incontinence, including bulking

Primary outcomes:
measure: Subjective responder rate after 12 months follow-up
timeFrame: 12 months
Secondary outcomes:
measure: ICIQ
timeFrame: Baseline, treatment, 1-, 6-, 12- and 24-months
measure: 24 hour urine leakage
timeFrame: Baseline, treatment, 1-, 6-, 12- and 24-months
measure: daily incidence of incontinence episodes
timeFrame: Baseline, treatment, 1-, 6-, 12- and 24-months
measure: Qol
timeFrame: Baseline, treatment, 1-, 6-, 12- and 24-months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Skejby Sygehus
city: Glostrup
country: Denmark
facility: KAS Glostrup
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Chemnitz
country: Germany
facility: DRK Gemeinnützige Krankenhaus Gmbh
city: Stockholm
country: Sweden
facility: Karolinska Institutet
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Worthing
country: United Kingdom
facility: Worthing Hospital
state: West Sussex
city: Birmingham
country: United Kingdom
facility: Birmingham Women´s Hospital
city: Hartlepool
country: United Kingdom
facility: University Hospital of Hartlepool
city: London
country: United Kingdom
facility: St. George´s Hospital
Study officials:
affiliation: KAS Glostrup
name: Gunnar Lose, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01820273: Changes in Incretins Response and Glycemic Control After Gastric Bypass Surgery in Type 2 Diabetic Patients Versus Healthy
Official title: Study of Incretins Response and Glycemic Control: Pre Diet, After Conventional Weight Loss and in the Early Postoperative Phase After Gastric Bypass in T2D-patients.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type 2 Diabetes
Obesity
Keywords: Type 2 diabetes
Bariatric surgery
incretines
GLP-1
GIP
gastric bypass
foregut
hindgut
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Kalmar County Hospital
First posted: 2013-03-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female obese (BMI\>35)patients accepted for bariatric surgery (lap gastric bypass). 10 patients with type 2 diabetes(T2D) 6 10 matched controls without T2D.

Brief summary: The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Also aiming for recording changes in the earliest postoperative phase.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of type 2 diabetes
* obesity BMI \>35

Exclusion Criteria:

* prior bariatric surgery

Primary outcomes:
measure: changes in incretines in the bariatric patient
timeFrame: 2 months prior to surgery - 6 weeks post surgery
Secondary outcomes:
measure: Diabetes control
timeFrame: 6 weeks post surgery
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Kalmar County Hospital
Study officials:
affiliation: Lunds Universitet, Clinical researchcenter
name: Nils Wierup
role: STUDY_DIRECTOR
affiliation: Lunds Universitet
name: Johan Berggren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05663073: Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers
Official title: A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-23
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Healthy Volunteer
* Other inclusion applies

Exclusion Criteria:

* Clinically relevant/significant findings as evaluated by the investigator
* Other exclusion applied

Primary outcomes:
measure: AUCt of Irbesartan and Amlodipne
timeFrame: 72 hours
measure: Cmax of Irbesartan and Amlodipne
timeFrame: 72 hours
Secondary outcomes:
measure: AUCinf of Irbesartan and Amlodipine
timeFrame: 72 hours
measure: AUCt/AUCinf of Irbesartan and Amlodipine
timeFrame: 72 hours
measure: tmax of Irbesartan and Amlodipine
timeFrame: 72 hours
measure: half-life of Irbesartan and Amlodipine
timeFrame: 72 hours
measure: CL/F of Irbesartan and Amlodipine
timeFrame: 72 hours
measure: Vz/F of Irbesartan and Amlodipine
timeFrame: 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
References:
Clinical trial NCT01733173: Functional Imaging of Cerebellar Mutism Syndrome
Official title: Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Mass
Keywords: mass in posterior fossa
benign
malignant
surgical resection
MRI
fMRI
DTI
12-121
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 4
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSK clinics

Brief summary: The purpose of this study is to better understand why some children with cancer have difficulty speaking after brain surgery. Difficulty speaking may be due to known complications to the language centers in the brain. These language centers may be located in slightly different places in different people. This study will study which areas may be damaged.


Eligibility criteria: Inclusion Criteria:

* Subject and/or guardian is able to provide written informed consent prior to study registration
* Age ≥3 years and ≤21 years
* Newly diagnosed, untreated mass in posterior fossa, either benign or malignant
* Is being evaluated for surgical resection of the mass
* Able to perform clinical language testing in English

Exclusion Criteria:

* Claustrophobia
* Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
* Pregnant or nursing female
* Does not speak English as a primary language (as determined by the P.I. or treating physician after discussion with a potential subject and his/her family)
* Preexisting language or developmental disorder that would limit ability to cooperate with testing (as determined by the P.I. or treating physician after interviewing potential subject and his/her family; for example, a child may be excluded if he/she has confirmed or suspected autism spectrum disorder, dysarthria, dyslexia, lisp, hypotonia, or other age inappropriate speech development)

Primary outcomes:
measure: investigate the feasibility of performing preoperative fMRI
timeFrame: 1 year
Secondary outcomes:
measure: To investigate potential changes in Diffusion Tensor Imaging (DTI) and tractography
timeFrame: 1 year
measure: To investigate potential changes in DTI after posterior fossa surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Robert J. Young, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02894073: Interest of a Skin Transilluminator (Such as the VeinViewer®Vision Device) for Peripheral Venous Catheter Placement in the Obese Patient
Official title: Interest of a Skin Transilluminator (Such as the VeinViewer®Vision Device) for Peripheral Venous Catheter Placement in the Obese Patient: a Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Surgery
Keywords: obese patients
peripheral venous catheter
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Placement of a peripheral venous catheter (PVC) is the most common invasive procedure in anaesthesia and perhaps even in the field of medicine as a whole.

Detailed description: Placement of a peripheral venous catheter (PVC) is the most common invasive procedure in anaesthesia and perhaps even in the field of medicine as a whole. This procedure may be challenging in the obese patient - even for the most experienced healthcare professionals.

In a study, PVC placement was considered to be difficult in 46% of obese patients but only 13% of non-obese patients.

Placement of a central venous catheter is an option when PVC placement is impossible, although central access is associated with a non-negligible risk of complications (pneumothorax, infection, arterial puncture, etc.).

Facilitating peripheral venous access in obese patients should shorten the time required for PVC placement, decrease the number of perfusion attempts (a source of dissatisfaction and discomfort for the patients) and limit the use of a central venous catheter.

Although a number of novel vein visualisation devices (such as the VeinViewer®Vision from Christie Medical) have been developed to guide PVC placement, there are no literature data on the value of these devices in the management of difficult venous access in obese patients.

Eligibility criteria: Inclusion Criteria:

* All obese adult patients scheduled for surgery.
* Social security coverage

Exclusion Criteria:

* Age \<18.
* Contra-indication to PVC placement.
* Legal guardianship.

Primary outcomes:
measure: duration of the PVC placement procedure
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Youssef ALAMI CHENTOUFI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03702673: Compare the Pharmacokinetic of K-877 Controlled Release (CR) and Immediate Release (IR) Tablets in Healthy Adults.
Official title: Single-Dose, Randomized, Open-Label, 4-Period, 4-Sequence Crossover Study of Three Prototypes of K-877 CR Tablet and Two K-877 Tablets Administered to Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A study to compare the pharmacokinetics of 3 types of K-877 controlled release tablets with a current normal K-877 tablet in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male or female aged 18 to 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Subject meets all inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check-in assessments.
* Subject has a supine blood pressure (as measured at Screening during the collection of vital signs) after resting for 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (males) or 50 mm Hg diastolic (females). If the initial blood pressure is out of range, blood pressure may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
* Subject has a supine pulse rate (as measured at Screening during the collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute. If the initial pulse rate is out of range, the pulse rate may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
* Subject does not meet any exclusion criteria outlined in the clinical study protocol.

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: Up to 24 hours after single administration
measure: Maximum Measured Plasma Concentration (Cmax)
timeFrame: Up to 24 hours after single administration
Secondary outcomes:
measure: Treatment emergent adverse events summarized by treatment
timeFrame: Up to 16 days after administration
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
References:
Clinical trial NCT02450773: Prevention of Severe Postpartum Hypertension
Official title: Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hypertension
Keywords: postpartum
preeclampsia
gestational hypertension
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether postpartum administration of furosemide to women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or elevated blood pressure in the first 24 hours following delivery reduces severe postpartum hypertension.


Eligibility criteria: Inclusion Criteria:

Women \> 18 years of age or emancipated minors

Women undergoing vaginal or cesarean delivery at \> 23 weeks gestation with:

* Antepartum diagnosis of gestational hypertension
* Antepartum diagnosis of preeclampsia
* Antepartum diagnosis of preeclampsia with severe features
* Mild hypertension (\<150/100) in first 24 hours following delivery

Exclusion Criteria:

* Chronic hypertension
* Allergy to furosemide
* Pre-existing hypokalemia (serum K \< 3.0 meq/L)
* Chronic kidney disease
* Serum Cr \> 1.1
* Inability to obtain informed consent
* Pre-existing diuretic use
* Oliguria

Primary outcomes:
measure: Composite maternal morbidity
timeFrame: 0-6 weeks following delivery
Secondary outcomes:
measure: Adverse events associated with furosemide
timeFrame: 0-6 weeks following delivery
measure: Adverse events associated with furosemide
timeFrame: 0-6 weeks following delivery
measure: Adverse events associated with furosemide
timeFrame: 0-6 weeks following delivery
measure: Adverse events associated with furosemide
timeFrame: 0-6 weeks following delivery
measure: Adverse events associated with furosemide
timeFrame: 0-6 weeks following delivery
Other outcomes:
measure: Cardiovascular changes following delivery
timeFrame: 0-1 week following delivery
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Indiana University School of Medicine
name: Methodius G Tuuli, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: