louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06698146: Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection
Official title: Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Transplant Surgery
Colorectal Cancer Metastatic
Colon Cancer Liver Metastases
Keywords: Liver Transplant
Colorectal Cancer Metastatic
Colorectal Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Northwestern University participants with liver metastases due to colorectal cancer (CRLM) who are eligible to liver transplant candidates

Brief summary: Liver transplantation (LT) has become an accepted treatment for selected patients with unresectable liver metastases due to colorectal cancer (CRLM). The goal of this study is to look at and compare the clinical results of all the different approved methods (living vs. Deceased, whole organ vs. Split, one staged vs. Two staged) used to perform a standard liver transplant procedure for recipients with CRLM. Investigators will look at things like different procedure results, recovery in the hospital, and survival rates one year after the transplant. Investigators will also take blood samples from participants to be used in future research. All the transplant methods the investigators are comparing are standard practices approved by the United Network of Organ Sharing (UNOS).


Eligibility criteria: Inclusion:

1. All Patients of either gender ≥ 18 years of age who are listed for Liver transplant candidates at Northwestern with liver metastases due to colorectal cancer (CRLM).
2. Subjects must be able to provide informed consent themselves and without the use of a legally authorized representative (LAR), to be determined by the PI or Sub-I at the time of Consent.

Exclusion:

1. Adults unable to consent
2. Pregnant Women
3. Certain clinical/surgical/anatomical parameters, at the discretion of the PI.

Primary outcomes:
measure: Graft and Patient Survival Outcomes
timeFrame: From liver transplant to 12 months
Secondary outcomes:
measure: Outcomes of liver transplant recipients
timeFrame: From liver transplant to 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University-Comprehensive Transplant Center
state: Illinois
Study officials:
References:
Clinical trial NCT05491746: Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study
Official title: Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Low Vision
Lead sponsor: Eyedaptic
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Diabetes has reached epidemic levels in North America and with it, diabetic retinopathy is increasingly affecting the vision of millions of people. Despite treatment many patients still have vision loss that cannot be improved medically or with prescription eyeglasses. Our study is going to look at an FDA Class 1 Exempted visual aid that uses augmented reality to help people see better.

Detailed description: In this study subjects will have their best corrected visual acuity and contrast sensitivity compared to their best vision and contrast with the Eyedaptic device. The Eyedaptic device is an FDA 510(k) Class 1 Exempt device as it is a visual aid. This is a pilot study to determine whether subjects with diabetic retinopathy associated vision loss obtain a benefit with augmented reality vision.

Subjects will receive a manifest refraction. When subjects have their optimal corrective lenses, the subjects' vision will be tested with their corrective lenses alone and again using the Eyedaptic device. This will be a single visit study, with no follow up.

Eligibility criteria: Inclusion Criteria:

* Best correct visual acuity in the better seeing eye between 20/60 and 20/800
* History of diabetic retinopathy

Exclusion Criteria:

* Unable to complete the visit
* Unable to give a reliable measurement of vision
* Unable to comfortably wear the glasses for at least 60 minutes

Primary outcomes:
measure: Visual acuity at distance
timeFrame: Day 1
Secondary outcomes:
measure: Visual acuity at near
timeFrame: Day 1
measure: Contrast sensitivity
timeFrame: Day 1
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Eyedaptic
state: California
Study officials:
affiliation: Eyedaptic
name: Mitul Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00608946: Treatment With Copper in Patients With Mild Alzheimer´s Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer´s Disease
Keywords: efficacy of treatment with copper in patients with mild Alzheimer´s disease
cognitive status over time
CSF and volumetric data over time (1 year)
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
Collaborators: name: University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany
First posted: 2008-02-06
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy of 8 mg of copper daily regarding cognitive function, content of beta amyloid protein in the CSF and volumetric changes in the brain will be examined in a first double-blind, placebo-controlled human clinical trial conducted in 70 patients with mild Alzheimer´s dementia.


Eligibility criteria: Inclusion Criteria:

* male or female patients
* between 50 and 80 years
* criteria of mild dementia
* probable Alzheimer´s dementia according to NINCDS-ADRDA criteria
* given written informed consent
* having a relative who can fill out questionnaire; caregiver consent
* free of serious and unstable somatic illness

Exclusion Criteria:

* unable to give informed consent
* unable to take cholinesterase inhibitors
* unapproved medication
* moderate to severe Alzheimer´s disease
* dementia of other etiology
* history of alcohol, drug or medication abuse
* other psychiatric disorder, e. g. schizophrenia
* known copper and zinc storage disease
* known copper and zinc intolerance
* vegans
* known severe allergies or intolerances
* insufficient knowledge of the German language
* female patients of childbearing potential, pregnant or nursing patients
* participation in a clinical trial within the past 30 days before onset of this study
* severe somatic diseases and high mortality rate AST, ALT, GGT, GLDH, AP or bilirubin being a two-fold above the normal range

Primary outcomes:
measure: change of cognitive function, measured by ADAS-cog
timeFrame: one year
Secondary outcomes:
measure: change of beta amyloid in the CSF and volumetric changes in the brain
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Psychiatry and Psychotherapy, The Saarland University Hospital
name: Frank G Pajonk, M.D., lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bayer TA, Schafer S, Simons A, Kemmling A, Kamer T, Tepest R, Eckert A, Schussel K, Eikenberg O, Sturchler-Pierrat C, Abramowski D, Staufenbiel M, Multhaup G. Dietary Cu stabilizes brain superoxide dismutase 1 activity and reduces amyloid Abeta production in APP23 transgenic mice. Proc Natl Acad Sci U S A. 2003 Nov 25;100(24):14187-92. doi: 10.1073/pnas.2332818100. Epub 2003 Nov 14.
Clinical trial NCT01739946: Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.
Official title: Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: William Beaumont Hospitals
First posted: 2012-12-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with either have OAB and will be undergoing an InterStim® implant (InterStim® group) or do not have bladder symptoms or an InterStim® device (Control group)

Brief summary: The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.

Detailed description: This study will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.

Eligibility criteria: OAB subjects (n=10 Phase I and n=10 Phase II)

Inclusion Criteria:

* Female
* Age 18-75 years
* Clinical symptoms of OAB (urgency and frequency with or without urge incontinence) for at least 3 or the 6 months immediately before the first visit.
* At least 8 voids/day and an average of 1 nocturnal void over 3 consecutive days on baseline bladder diary.
* InterStim® treatment naïve or being revised with a new lead

Exclusion Criteria:

* Pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination/medical record review
* Implanted Programmable Generator (IPG) is not implanted/connected to the tined lead (failed Stage I)
* Revision of only the IPG (without replacement of the tined lead)
* More than one InterStim® device being placed (undergoing bilateral stimulation)

Controls (n=10)

Inclusion:

* Female
* Age 18-75 years
* Deny history of OAB diagnosis or symptoms (urgency and frequency with or without urge incontinence)
* American Urological Association (AUA) symptom score of ≤4

Exclusion:

-History of pelvic mass, prolapse, urinary retention, or pelvic malignancy within the last year

Primary outcomes:
measure: Nerve Growth Factor (NGF) levels
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Michael Chancellor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peters KM, Jayabalan N, Bui D, Killinger K, Chancellor M, Tyagi P. Effect of Sacral Neuromodulation on Outcome Measures and Urine Chemokines in Interstitial Cystitis/Painful Bladder Syndrome Patients. Low Urin Tract Symptoms. 2015 May;7(2):77-83. doi: 10.1111/luts.12054. Epub 2014 Mar 17.
Clinical trial NCT06926946: SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes
Official title: The Effects of Treatment Guided by Cerebral Oximetry Monitoring on Renal Outcomes in Invasively Mechanically Ventilated Neonates: an Ancillary Study of the SafeBoosC-IIIv Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Renal Failure
Neonatal Morbidity
Keywords: Cerebral oximetry
NIRS
Neonate
Ventilated
Kidney injury
Lead sponsor: St. John's Research Institute
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2025-04-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cerebral oximetry monitoring allows clinicians to optimize blood flow to the brain and oxygenation using the SafeBoosC treatment guideline. The guideline's interventions aims to stabilize blood pressure and oxygen levels.

As low blood pressure is a risk factor for the development of kidney injury, normalizing blood pressure may decrease the incidence of kidney injury in new-borns who are on ventilator.


Eligibility criteria: Inclusion Criteria:

* \> 28 weeks of gestation Invasively ventilated

Exclusion Criteria:

* major anomalies

Primary outcomes:
measure: composite outcome of death and acute kidney injury
timeFrame: From randomization to discharge up to 2months of life
Secondary outcomes:
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: St. jOhn's Medical college & Hospital
state: Karnataka
Study officials:
References:
Clinical trial NCT01674946: Effect of Bile Acids on the Secretion of Satiation Peptides in Humans
Official title: Effect of Intraduodenal Perfusion of Bile Acids on the Secretion of Gastrointestinal Satiation Peptides in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Echolocation
Keywords: GI-physiology
CDCA
bile acids
TGR5
satiation peptides
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is do determine the functional significance of the G protein-coupled receptor TGR5 in the secretion of GI satiation peptides by using natural bile acids and oleanolic acid (triterpenoid compound of plant origin) as TGR5 agonists.

Detailed description: TGR5 is expressed in GLP-1-secreting cell lines and L cells from mice; gain- and loss-of-function models suggest a physiological role for TGR5 activation on GLP-1 secretion in rodents. TGR5 signaling showed improved postprandial glucose tolerance in obese mice, associated with marked postprandial GLP-1 release and insulin secretion. In contrast, TGR5-/- mice exhibited reduced glucose tolerance. In animals, TGR5 activation has been shown for natural bile acids (BAs) and triterpenoid compounds of plant origin, such as oleanolic acid (OA), suggesting a role for postprandial BAs in modulating nutrient-induced GLP-1 secretion. We therefore hypothesized that intraduodenal (ID) perfusions of TGR5 agonists (BAs and OA) stimulate the secretion of GLP-1 with respective changes in the glucose metabolism of healthy humans.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* BMI of 19.0-24.5
* Age 18-40
* Stable body weight for at least 3 months

Exclusion Criteria:

* Smoking
* Substance abuse
* Regular intake of medication
* Medical of psychiatric illness
* Gastrointestinal disorders or food allergies

Primary outcomes:
measure: Gastrointestinal satiation peptide secretion
timeFrame: 3 hours blood sampling
Secondary outcomes:
measure: Serum bile acids
timeFrame: 3 hours blood sampling
measure: Appetite perceptions during 3 hours using visual analogue scales
timeFrame: 3 hours
measure: Glucose and insulin secretion
timeFrame: 3 hours blood sampling
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Phase 1 Research Unit
Study officials:
affiliation: University Hospital Basel, Phase 1 Research Unit, Basel Switzerland
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04025346: To Evaluate the Efficacy of Capsimax on Metabolic Rate
Official title: A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Efficacy of Capsimax on Metabolic Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blind, randomized, placebo controlled
Primary purpose: OTHER

Brief summary: Capsimax™ is a proprietary Capsicum Extract that employs Beadlet Technology. In the previous study it has been used to investigate its effect in reducing body fat/weight and increase metabolic rate. In this study, Capsimax™ will be used to assess effect on Resting Energy Expenditure (REE) using Indirect Calorimetry.


Eligibility criteria: Inclusion Criteria:

* Healthy, adult, male/female participants with age ≥ 18 ≤ 55 years.
* A Body Mass Index (BMI) between 18.5 to 29.9 kg/m2.
* Fasting blood sugar ≤ 100 mg/dl
* Hemoglobin: Males ≥ 11 g/dl and Females ≥ 10 g/dl
* BP \< 140/90 mmHg

Exclusion Criteria:

* Post-menopausal females
* History of hypo/ hyperthyroidism.
* History of significant neurological or psychiatric condition such as seizures, depression, or insomnia.

Primary outcomes:
measure: Effect of Investigational Product on Resting Energy Expenditure
timeFrame: From baseline to 4 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Thāne
country: India
facility: Vedic Lifesciences Pvt. Ltd.
state: Maharashtra
Study officials:
References:
Clinical trial NCT01841346: The First Jordanian PCI Registry: Events at 1 Year
Official title: The First Jordanian Percutaneous Coronary Intervention (PCI) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Percutaneous Coronary Intervention
Keywords: Outcome after PCI
Middle Eastern Patients
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2013-04-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with acute coronary syndrome and stable coronary syndromes undergoing PCI.

Brief summary: The investigators will look at the short- (in hospital) and long- term ( 1 year)outcome in consecutive patients who undergo stent implantation and angioplasty in Jordan.

Detailed description: 1. Voluntary registry of consecutive patients undergoing Percutaneous coronary intervention (PCI).
2. Patients will be treated according to the treating cardiologists' discretion. No randomization of any medication or stent.
3. Baseline data on admission will be collected (cardiovascular risk factors, blood lipids, ect).
4. PCI procedure details and complications will be documented during the index admission.
5. Outcome events (death, MI, revascularization, stent thrombosis) will be evaluated at 1, 6, and 12 months by clinic visits or phone calls.

Eligibility criteria: Inclusion Criteria:

* Consecutive PCI patients
* Arab nationality

Exclusion Criteria:

* less than 18 year of age

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: 1 year
Secondary outcomes:
measure: Admission for urgent coronary revascularization
timeFrame: 1 year
Other outcomes:
measure: Stent thrombosis
timeFrame: 1 year
measure: Baseline risk factors and outcome after 1 year
timeFrame: 1 year
measure: Adherence to guidelines in patients undergoing PCI
timeFrame: 1 year
Locations:
city: Amman
country: Jordan
facility: Istishari Hospital
Study officials:
References:
Clinical trial NCT01062646: Multimodal Music Therapy for Children With Anxiety Disorders
Official title: A Randomized Controlled Trial of Multimodal Music Therapy for Children With Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety
Keywords: music therapy
multimodal psychotherapy
children
anxiety disorders
pediatric anxiety
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multimodal music therapy (MT) for children ages 8 to 12 years with anxiety disorders is compared to community treatment as usual (TAU). 36 children were randomized either to MT or to TAU. Primary outcome is presence of an anxiety disorder at the end of treatment. Secondary outcomes are self- and parent-/teacher reported anxiety, co-morbid psychological symptoms, and quality of life. Stability of outcome is assessed six months after the end of treatment.

Detailed description: Patients were enrolled in a community clinic and in an outpatient clinic for child and adolescent psychiatry/psychotherapy. Inclusion criteria: diagnosis of an anxiety disorder (separation anxiety disorder, general anxiety disorder, social phobia, specific phobia, or other anxiety disorder); age 8-12; no medication or stable medication during treatment; IQ\>80; informed consent of caregivers and informed assent of patients. Outcome measures. Kiddie-SADS; STAIC-C, SPAIC, CDI; SDQ teacher report; CBCL 4-18; ILK quality of life inventory. Assessment time points: pre-intervention; post-intervention; 6-months follow-up.

Eligibility criteria: Inclusion Criteria:

* age 8-12 years
* diagnosis of an anxiety disorder
* IQ\>80
* informed consent and assent

Exclusion Criteria:

* anxiety disorder is not primary focus of treatment

Primary outcomes:
measure: Diagnosis of an anxiety disorder (DSM IV)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Ulm
name: Lutz Goldbeck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06492746: Personal BP - CAI Study
Official title: Assessing for Personalized Blood Pressure Targets During Cardiopulmonary Bypass With the Proprietary Cerebral Adaptive Index: A Pilot Investigation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Age ≥ 45 years
3. Planned cardiac surgery with Cardiopulmonary Bypass (CPB)
4. Planned monitoring with ForeSight sensor and HemoSphere monitor
5. Planned arterial catheterization for blood pressure monitoring
6. High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure \> 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease

Exclusion Criteria:

1. Non-English speaking
2. Confirmed to be pregnant
3. Surgery for congenital heart defect
4. Non-availability of HemoSphere with laptop CAI interface

Primary outcomes:
measure: To determine the magnitude and duration of CAI
timeFrame: Duration of the procedure through 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University Hospital
state: Illinois
Study officials:
References: