louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00172796: Pancreatic Islet Function, Insulin Sensitivity, and Chronic Complications in Pre-Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prediabetic State
Obesity
Metabolic Syndrome X
Keywords: Metabolic syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: We, the investigators at National Taiwan University Hospital, want to compare patients' islet cell function, insulin sensitivity and risk of chronic complications with normal subjects. Moreover, we want to examine whether they are at a higher risk of having metabolic syndrome and to answer whether we should screen the phenotypes of metabolic syndrome in impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) patients. Then, we want to examine the association between insulin sensitivity and islet functions.

Detailed description: We, the investigators at National Taiwan University Hospital, want to compare patients' islet cell function, insulin sensitivity and risk of chronic complications with normal subjects. Moreover, we want to examine whether they are at a higher risk of having metabolic syndrome and to answer whether we should screen the phenotypes of metabolic syndrome in impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) patients. Then, we want to examine the association between insulin sensitivity and islet functions.

Eligibility criteria: Inclusion Criteria:

* Fasting glucose 100-125 mg/dl OR oral glucose tolerance test (OGTT) 2 hour glucose 140-199 mg/dl
* Diabetes mellitus

Exclusion Criteria:

* Pregnancy
* Children \< 18 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Yun-Lin
country: Taiwan
facility: Department of Internal Medicine, Yun-Lin Branch, National Taiwan University Hospital
Study officials:
affiliation: Yun-Lin Branch, National Taiwan University Hospital
name: Hung-Yuan Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00116896: Phase I Study of Cisplatin Plus OSI-7904L in Patients With Solid Tumors
Official title: Phase I Study of OSI-7904L in Combination With Cisplatin in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: OSI Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-07-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Advanced and/or metastatic solid tumor for which no effective therapy is available
* ECOG performance status 0-2
* Adequate bone marrow, hepatic and renal function

Exclusion Criteria:

* Patients with active or uncontrolled infections
* Neurotoxicity \>= Grade 2
* Symptomatic brain metastases which are not stable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Universtiy Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Institute for Drug DevelopmentCancer Therapy & Research Center
state: Texas
Study officials:
References:
Clinical trial NCT06299696: A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists
Official title: A Phase 1, Open-label Taste Assessment Study of Vanzacaftor/Tezacaftor/Deutivacaftor in Healthy Adult Panelists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Panelists are trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations.

Key Exclusion Criteria:

* History of any illness or clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant.
* Sensitivity to VNZ, TEZ, or D-IVA.
* Pregnant, nursing, or planning to become pregnant during the study

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Flavor Assessment Based on Flavor Profile Method of Descriptive Sensory Analysis per American Society for Testing and Material (ASTM) Approved Sensory Evaluation Method
timeFrame: Periodic Intervals up to 30 minutes post oral administration
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: Site 001
state: Massachusetts
Study officials:
References:
Clinical trial NCT06622096: Evaluation of Lab Exams Accuracy in the Intensive Care Unit
Official title: Rationalization of Laboratory Tests in the ICU: Current State of Play
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laboratory Testing
Intensive Care Unit ICU
Accuracy
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted in the ICU for more than 24 hours

Brief summary: prospective, observational descriptive study assessing the accuracy of laboratory exams in the ICU.

Detailed description: Laboratory exams prescription for ICU patients was evaluated daily and their accuracy was determined according to locally implemented prescription protocol and to their abnormalities and the impact on further therapeutics.

Eligibility criteria: Inclusion Criteria:

* All adults ICU patients with a length of stay\&gt;24 hours

Exclusion Criteria:

* Patients transferred from other ICUs
* Currently unavailable laboratory tests

Primary outcomes:
measure: Blood loss due to laboratory tests
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi Slim University Hospital
Study officials:
References:
Clinical trial NCT06911996: The WOW Project (WOW): Wonders Of The World Through Virtual Reality for Hospitalized Children
Official title: Immersive Bedside Teaching for Hospitalized Pediatric Patient - A Prospective, Mixed-method, Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Virtual Reality
Keywords: Immersive Learning
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hospitalized pediatric patients are unable to leave the hospital to engage in traditional learning environments. Patients often feel depressed, disconnected from learning, and socially withdrawn. The Stanford Chariot Program proposes a partnership with the Palo Alto Unified Hospital School at Stanford Children's Health to reignite patients' emotional well-being through learning. The WOW Project aims to use virtual reality (VR) to travel with hospitalized children to the Wonders of the World (WOW). Combining this immersive learning modality with complementary hands-on activities at the bedside, the investigators will transport them from their hospital room into a nurturing virtual environment to stimulate their emotional, mental, and social growth while they are physically healing. The investigators will evaluate their overall joy and awe of learning by using standardized emotional scales.


Eligibility criteria: Inclusion Criteria:

* Between the age of 5 and 17.
* English speaking.
* Anticipated in-patient stay for more than 1 day.

Exclusion Criteria:

* Legal guardian not present to obtain consent
* Child with a significant neurological condition, or major developmental disability
* Child with active infection of the face or hand
* A history of severe motion sickness
* A history of seizures caused by flashing light
* Major surgery within the last 12 hours

Primary outcomes:
measure: Assess the impact of VR-based field trips on the feeling of awe of the pediatric inpatient population
timeFrame: immediately after intervention
Secondary outcomes:
measure: Change in the number of correct answers of the content knowledge
timeFrame: Day 1 baseline, Day 1 immediately after intervention
measure: Change in a patients' well-being as measured through the World Health Organization-Five Well-Being Index (WHO-5)
timeFrame: Day 1 baseline, Day 1 immediately after intervention
measure: Thematic analysis of the qualitative surveys including how the lesson engagement correlates to the increase in joyful learning.
timeFrame: immediately after intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00089596: Infusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers
Official title: A Safety Study of Infusion of Ex Vivo Selectively Amplified Unrelated Cord Blood Stem Cells in Subjects With Hematological Malignancies Receiving Unrelated Cord Blood Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Lymphocytic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Non-Hodgkin Lymphoma
Chronic Myelogenous Leukemia
Keywords: umbilical cord blood
transplant
ALL
AML
MDS
NHL
CML
Lead sponsor: ViaCell
Sponsor class: INDUSTRY
First posted: 2004-08-10
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study hopes to show that specially treated umbilical cord cells, called stem cells, can be safely given to a person after they receive chemoradiation therapy or chemotherapy for their illness. During chemoradiation therapy or chemotherapy, a person loses all of the cells that are needed to make the different types of cells in their blood, including their immune system cells. These cells must be replaced in order for the blood and immune systems to work properly. Some people receive bone marrow transplants or other types of stem cell transplants to get the cells they need. CB001 is being developed as an option for people who need bone marrow transplants or other types of transplants to replace those cells. It is also being developed for people who do not have the option of other types of transplants.


Eligibility criteria: Inclusion Criteria:

* Do not have identical or 5/6 related matched bone marrow, peripheral blood or umbilical cord
* Stable disease and lack of unrelated donor
* Acute myeloid leukemia (AML) in 2nd or subsequent complete remission or first remission with high risk features
* ALL in 2nd or subsequent remission or first remission with high risk features
* Myelodysplastic syndrome (MDS)
* Non-Hodgkin Lymphoma (NHL)
* Chronic Myelogenous Leukemia (CML)
* Adequate function of heart, liver, kidneys and lungs

Exclusion Criteria:

* Females who are pregnant
* Poor ability to perform daily activities
* Weight under 40 kilograms (88 pounds)
* AML caused by chemoradiation
* Prior stem cell transplant
* Uncontrolled infection at time of transplant
* Active fungal infection
* HIV infection
* Primary myelofibrosis
* Receiving other research drugs
* Unable to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: ViaCell
name: Kurt Gunter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00900796: Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis
Official title: Success and Failure of Biological Therapy: Predictors of Response in Patients With Active Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing spondylitis;predictive factors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active ankylosing spondylitis treated in rheumatology units

Brief summary: The objective of this observational study is to determine the incidence of response in patients with predictive factors of major clinical response in active ankylosing spondylitis (AS) in patients who start anti-tumor necrosis factor (anti-TNF) therapy and correlate these findings in patients who switch from one to another anti-TNF due to inefficacy under usual clinical practice conditions in Spain.

Detailed description: A sample size of 240 patients, 120 of them exposed and 120 not exposed to factors of response. Sample will be obtain from all the consecutive patients attending the rheumatology settings included in the study who fulfill the inclusion criteria

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed of active AS who will start anti-TNF therapy following standard clinical practice as per summary of product characteristics doses.
* \>18 years, both genders, any disease duration
* Signature of informed consent

Exclusion Criteria:

* Previous treatment with biological therapies
* Active tuberculosis infection (local guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy must be followed)

Primary outcomes:
measure: Percentage of Participants With a Clinical Response
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment
timeFrame: Week 32
measure: Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment
timeFrame: Week 32
measure: Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy
timeFrame: Week 16
measure: Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks
timeFrame: Week 32
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00150696: Risedronate for the Prevention of Osteoporosis in People With Spinal Cord Injury.
Official title: Risedronate for Prevention of Osteoporosis After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Spinal Cord Injury.
Keywords: Osteoporosis
Spinal Cord Injury
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Ontario Neurotrauma Foundation
name: St. Joseph's Healthcare Foundation
name: Queen Elizabeth Hospital NHS Foundation Trust
First posted: 2005-09-08
Enrollment: 38
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to find out if Risedronate works to prevent osteoporosis after spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* Traumatic spinal cord injury less than 100 days.
* Must be able to swallow tablets and sit upright.

Exclusion Criteria:

* Bilateral knee flexion contractures.
* Pregnant, lactating or post-menopausal females.
* Paget's disease, osteomalacia, steroid induced bone loss, untreated thyroid disease, iritis, uveitis, pancreatitis, gastritis, peptic ulcer or cholecystitis.
* Treatment in the last year with calcitonin, fluoride or anabolic steroid.
* Concurrent treatment with prednisone.

Primary outcomes:
measure: Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.
Secondary outcomes:
measure: Change in bone mineral density of the total body, spine and femoral neck between baseline, 12-months and 24-months.
measure: Change in biochemical markers of bone turnover between baseline, 12-months and 24-months.
measure: Frequency and severity of adverse events.
measure: Quality of life.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, Chedoke Site
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehab, Lyndhurst Centre
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: B. Cathy Craven, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01624116: Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes
Official title: A Comparison of Four Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetic Patients and the Effect of Add-On Acarbose on Glycaemic Excursions During Ramadan Fasting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Type 2
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2012-06-20
Enrollment: 161
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 2 diabetic patients who fast during Ramadan experience swings in glycaemic control between hypoglycaemic troughs and hyperglycaemic spikes. Hence, the dual challenge in fasting diabetics is to identify which treatment modality leads to the most stable blood glucose levels during a fast and how to smooth out these excursions and reduce risks of fast to a minimum.

Detailed description: Study Objectives:

* To compare changes in clinical and metabolic parameters from baseline to the end of four weeks fasting in Ramadan between four treatment arms:

  * diet and lifestyle measures alone.
  * metformin monotherapy.
  * combination therapy with metformin + sulfonylurea.
  * combination therapy with metformin + sitagliptin.
* To compare the 24 hour CGMS profile during Ramadan fasting in type 2 diabetic patients before and after addition of acarbose to these pre-existing sub-maximal hypoglycaemic regimens.

Eligibility criteria: Inclusion Criteria:

* HbA1c 6.5-9.5%.
* Type 2 diabetics on two or less oral hypoglycaemic agents.

Exclusion Criteria:

* Any contraindications either to fasting or to any of the trial medication.
* Pregnancy.
* Serum creatinine \> 1.4 mg/dl.
* Serum ALT \> twice upper limit normal.
* History of pancreatitis, serum amylase \> twice upper limit normal.
* History of intolerance to acarbose.

Primary outcomes:
measure: Change in body weight and fructosamine levels during Ramadan fasting.
timeFrame: 28 days (Average duration of Ramadan fasting)
Secondary outcomes:
measure: Change in fasting lipid profile from baseline to end of Ramadan.
timeFrame: 28 days(average duration of Ramadan)
measure: Change in ghrelin levels from baseline to end of Ramadan.
timeFrame: 28days (average duration of Ramadan)
measure: Change in renal profile from baseline to end of Ramadan
timeFrame: 28 days(average duration of Ramadan)
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Endocrinology Unit & Diabetes Management Centre, Services Hospital.
Study officials:
affiliation: Services Hospital.
name: Dr Khadija Irfan, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00231816: A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)
Official title: A Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of V211 Administered Concomitantly Versus Nonconcomitantly With Influenza Virus Vaccine (Inactivated)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Keywords: Prevention of Herpes Zoster
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 763
Sex: ALL
Minimum age (years): 50
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 determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.


Eligibility criteria: Inclusion Criteria:

* Adults 50 years of age or older

Exclusion Criteria:

* Prior history of Herpes Zoster (shingles)
* Prior receipt of varicella or zoster vaccine
* Immunosuppressed

Primary outcomes:
measure: Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
measure: Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination
timeFrame: prevaccination to 4 weeks postvaccination
measure: Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination
timeFrame: 4 weeks postvaccination
measure: GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination
timeFrame: 4 weeks postvaccination
measure: GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination
timeFrame: 4 weeks postvaccination
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kerzner B, Murray AV, Cheng E, Ifle R, Harvey PR, Tomlinson M, Barben JL, Rarrick K, Stek JE, Chung MO, Schodel FP, Wang WW, Xu J, Chan IS, Silber JL, Schlienger K. Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older. J Am Geriatr Soc. 2007 Oct;55(10):1499-507. doi: 10.1111/j.1532-5415.2007.01397.x.
citation: Sutradhar SC, Wang WW, Schlienger K, Stek JE, Xu J, Chan IS, Silber JL. Comparison of the levels of immunogenicity and safety of Zostavax in adults 50 to 59 years old and in adults 60 years old or older. Clin Vaccine Immunol. 2009 May;16(5):646-52. doi: 10.1128/CVI.00407-08. Epub 2009 Mar 4.