louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00916604: To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients
Official title: A Randomized, Single-blind, Placebo-Controlled, Multi-centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: AZD1656
Safety
Pharmacokinetics
Pharmacodynamic
Multiple ascending doses
Japanese
T2DM
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-09
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female non-childbearing potential Japanese T2DM patients, 30-75 years.
* A body mass index (BMI) of 19 to 27 kg/m2.
* Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.

Exclusion Criteria:

* Renal dysfunction GFR \< 60 mL/min.
* Systolic pressure (SBP) \> 160 mmHg or diastolic pressure (DBP) \> 95 mmHg
* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP.
* History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.

Primary outcomes:
measure: Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Secondary outcomes:
measure: Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR).
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
measure: Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide).
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Klas Malmberg, MD
role: STUDY_DIRECTOR
affiliation: PS Clinic, Fukuoka, Japan
name: Takashi Eto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HONJO CLINIC II, Tokyo, Japan
name: Mitsuyasu Hokamura, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01197404: Affect Management for Early Adolescents
Official title: Affect Management Intervention for Early Adolescents With Mental Health Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV Prevention
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 420
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adolescents are at risk for HIV because of sexual and drug use behavior initiated during early adolescence, and those with mental health problems appear to be particularly susceptible. Problems with managing emotions may make it difficult for early adolescents to make good decisions about sexual and substance use behaviors. This project will develop and evaluate interventions for early adolescents with mental health issues. An intervention focused on teaching affect management skills will be compared to an intervention addressing a variety of health topics to determine which intervention best reduces risk behavior among this at-risk population.


Eligibility criteria: Inclusion Criteria:

* Seventh graders identified by counselors at participating public school.

Exclusion Criteria:

* Adolescent is HIV positive.
* Adolescent is developmentally delayed.
* Adolescent is pregnant.
* Adolescent has a history of sexual crime.

Primary outcomes:
measure: Adolescent-reported sexual activity
timeFrame: 30 Months
Secondary outcomes:
measure: Adolescent-reported condom use
timeFrame: 30 Months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Christopher D Houck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Houck CD, Hadley W, Barker D, Brown LK, Hancock E, Almy B. An Emotion Regulation Intervention to Reduce Risk Behaviors Among at-Risk Early Adolescents. Prev Sci. 2016 Jan;17(1):71-82. doi: 10.1007/s11121-015-0597-0.
citation: Houck CD, Barker DH, Hadley W, Menefee M, Brown LK. Sexual Risk Outcomes of an Emotion Regulation Intervention for At-Risk Early Adolescents. Pediatrics. 2018 Jun;141(6):e20172525. doi: 10.1542/peds.2017-2525. Epub 2018 May 10.
citation: Houck CD, Barker D, Rizzo C, Hancock E, Norton A, Brown LK. Sexting and sexual behavior in at-risk adolescents. Pediatrics. 2014 Feb;133(2):e276-82. doi: 10.1542/peds.2013-1157. Epub 2014 Jan 6.
Clinical trial NCT00141804: Efficacy and Safety of Sirolimus in Combination With Tacrolimus
Official title: A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: renal transplantation
immunosuppression
prevention of acute rejection
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Proverum GmbH
name: KKS Netzwerk
name: Fujisawa GmbH
First posted: 2005-09-01
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation

Detailed description: Basic randomized clinical trial (multicentre) in primary KTX to assess the safety and efficacy of a tac/rapa vs a tac/MMF regimen. Tac trough levels in accordance with current standards in both arms. Steroids to be used to individual centre protocol. Rapa trough levels will be adjusted to 5-10 ng/ml. Up to now only few data (primate and clinical) on tac/rap combinations available.

Eligibility criteria: Inclusion Criteria:

* first kidney transplantation
* re-transplantation
* non-related living donor transplantation
* patients \> 18 years
* patients have given their written consent after being informed
* female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test

Exclusion Criteria:

* related living donation
* patients with known HIV-anamnesis
* patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection
* patients with present malignant disease
* patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer
* patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority
* other reasons which depend on the assessment of the physician

Primary outcomes:
measure: - time to first biopsy proven acute rejection episode at month 12
measure: - graft failure at month 12
measure: - discontinuation of study medication at month 12
Secondary outcomes:
measure: - patient and graft survival at month 12
measure: - incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12
measure: - Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance)
measure: - incidence and severity of infections at month 12
measure: - incidence of adverse events at month 12
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: University Hospital Muenster
name: Heiner H. Wolters, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04340804: Effect of kcal and PACE Labelling on Self-served Portion Size
Official title: Socioeconomic Position and the Effect of kcal Labelling and PACE Labelling on Self-served Portion Size
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Food Selection
Keywords: kcal labelling
PACE labelling
portion size
socio-economic position
Lead sponsor: University of Liverpool
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Participants will take part in an online survey. They will be asked to choose the amount of food they would like to eat based on pictures of 18 dishes sequentially displayed on the screen. They will be randomly allocated to four different groups: kcal labelling, PACE labelling (Physical Activity Calorie Equivalent: minutes to walk to burn off the calories), kcal and PACE labelling combined, no labelling, in a between subject design. The main outcome variable is the total "self-served" energy for each dish (in kcal).

Detailed description: See attached protocol documents.

Eligibility criteria: Inclusion Criteria:

* United Kingdom residents
* Age ≥ 18
* Fluent in English
* Have access to a computer and Internet

Exclusion Criteria:

* Have any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, diary or lactose free, food allergy)

Primary outcomes:
measure: Total self-served energy (kcal)
timeFrame: 10 minutes (the time frame denotes time taken to perform the portion selection task and there is no follow up)
Secondary outcomes:
measure: Kcal influence
timeFrame: 3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
measure: PACE influence
timeFrame: 3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool
state: Merseyside
Study officials:
References:
Clinical trial NCT02523404: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Lung Cancer
Official title: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Lung Cancer: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Keywords: Lung Cancer
HepaSphere
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for lung cancer.

Detailed description: By enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for lung cancer.

Eligibility criteria: Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of lung cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except lung cancer
2. History of coagulation disorders or anemia

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
timeFrame: 1 year
measure: Progress free disease (PFS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
citation: Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24.
Clinical trial NCT03316404: Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response
Official title: Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
MS
Keywords: Multiple Sclerosis
MS
Lead sponsor: DxTerity Diagnostics
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 1168
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: Participants diagnosed with Multiple Sclerosis (MS)

Brief summary: To develop a test to characterize and monitor Multiple Sclerosis (MS) disease status and therapy response from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.

Detailed description: Multiple Sclerosis (MS) is an autoimmune disease that damages the central nervous system (CNS) and disrupts communication to and from the brain by attacking the myelin sheath surrounding neurons. It impairs control of bodily functions and leads to clinical disability as the disease progresses. The worldwide population is estimated at 2.5 million. MS typically develops in young adults; primarily women in their early 30s. The etiology of MS is not fully understood, but it is noted that the prevalence of MS differs with geography and ethnicity.

Biomarker signature panels are important tools for monitoring treatment response and screening for individuals who are unlikely to benefit from certain therapies. To establish a baseline and further characterize gene expression in MS, blood samples from individuals with MS will be collected. A rapid blood test to predict a treatment response would be an innovative diagnostic product that could aid in identifying individuals that may benefit from the targeted therapy. In the long term, such a test could bring significant clinical benefits by enabling individualized treatment to better control the disease, unburdening healthcare costs, and dramatically improving the management of MS.

In order to analyze gene expression data from individuals diagnosed with MS, the study will collect blood samples and information from up to 1500 subjects for analysis.

Eligibility criteria: Inclusion Criteria:

* Male and female patients age 18 or older
* Have a permanent address in the United States for the duration of the study
* Have an email address and access to the internet for the duration of the study
* Able to provide informed consent
* Self-reported diagnosis of MS

Exclusion Criteria:

* None

Primary outcomes:
measure: Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Compton
country: United States
facility: DxTerity Diagnostics
state: California
Study officials:
References:
Clinical trial NCT04447404: DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
Official title: A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of DUR-928 in Subjects Infected With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: SARS-CoV-2
Lead sponsor: Durect
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3:1 randomization DUR-928:placebo
Primary purpose: TREATMENT

Brief summary: Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2


Eligibility criteria: Inclusion Criteria:

* Hospitalized with moderate, severe, or early critical COVID-19 illness diagnosed by RT- PCR
* Acute liver injury (including acute on chronic liver disease) or acute kidney injury or moderate COVID-19 pneumonia

Exclusion Criteria:

* Critical COVID-19 illness (MAP \< 60 mm Hg, on mechanical ventilator for ≥ 5 days)
* On maintenance hemodialysis or peritoneal dialysis
* Child Pugh C cirrhosis
* Hepatorenal syndrome
* Ascites and/or hepatic encephalopathy
* History of end stage renal disease or CKD with eGFR \< 15 mL/min/1.73m2
* Women who are pregnant or breast feeding
* Receipt of other concomitant experimental therapies

Primary outcomes:
measure: Composite Endpoint of Alive and Free of Organ Failure at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Alive at Days 28 and 60
timeFrame: Day 28 and Day 60
measure: Alive, Out of ICU, at Day 28
timeFrame: Day 28
measure: Alive, Out of Hospital, at Days 28 and 60
timeFrame: Day 28 and Day 60
Other outcomes:
Locations:
city: Newark
country: United States
facility: Site 03
state: New Jersey
Study officials:
affiliation: CTI Clinical Trial and Consulting Services
name: Robert Gordon, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03980704: Preoperative High Protein vs Immunodiet in Surgical Cancer Patients
Official title: Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: General Surgery
Cancer of Colon
Keywords: immunonutrition
preoperative nutrition
Lead sponsor: Stanley Dudrick's Memorial Hospital
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.

Detailed description: Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.

Eligibility criteria: Inclusion Criteria:

* resectable GI cancer
* written consent

Exclusion Criteria:

* inoperable GI cancer
* known allergy to the drug

Primary outcomes:
measure: Infectious complications
timeFrame: 6 months
Secondary outcomes:
measure: Surgical complications
timeFrame: 6 months
measure: Length of stay
timeFrame: 14 days
Other outcomes:
Locations:
city: Skawina
country: Poland
facility: Stanley Dudrick's Memorial Hospital
Study officials:
affiliation: Stanley Dudrick's Memorial Hospital
name: Stanislaw Klek
role: STUDY_DIRECTOR
References:
Clinical trial NCT01747304: Evaluation of IVA (SE Femur Scans) to Identify Incomplete AFFs
Official title: Evaluation of Dual Energy X-ray Absorptiometry Scanners in the Identification of Atypical Femur Fractures - A Validation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atypical Femur Fracture
Keywords: Atypical Femur Fracture
DXA
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Osteoporosis/Bone Mineral Density Lab out-patients

Brief summary: DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic manufactures scanners that are able to perform high definition instant vertebral fracture assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine fractures instantly and reliably at the same time they are having their yearly BMD. We wish to investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the scan mode is now called SE Femur scans) can be used to screen for atypical fractures of the femur in patients at risk for these debilitating fractures. In this proof of concept study, we propose to examine whether DXA scanners can provide a sensitive low radiation screening method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at risk.


Eligibility criteria: Inclusion Criteria:

Known AFF group

1. A subject must have experienced an incomplete atypical low trauma fracture of the femoral shaft;
2. Is a patient at the UHN osteoporosis clinic.

Comparison Group

1. Must be scheduled for a bone mineral density scan at UHN
2. Have been on any bisphosphonate for 5 years or longer, and;
3. Have unexplained symptoms of leg, hip, thigh, or knee pain.

Exclusion Criteria:

* There are no exclusions

Primary outcomes:
measure: HD-IVA visualization of incomplete femur fractures
timeFrame: 1 day (one time point )
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Angela M Cheung, MD, PhD, CCD
role: PRINCIPAL_INVESTIGATOR
References: