louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00770302: Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin
Official title: An Open Label, Pharmacokinetic Study of Single and Multiple Doses of 5 mg Saxagliptin in Healthy Chinese Subjects Living in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: DPP-4 inhibitors
HBA1c
Incretins
Pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-10-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses of 5 mg saxagliptin in healthy Chinese subjects.


Eligibility criteria: Inclusion Criteria:

* Men or women (not of childbearing potential) of Chinese ethnicity
* Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2
* Must have normal physical examination, laboratory values, ECG, pulse and blood pressure unless the investigator considers an abnormality to not be clinically significant.

Exclusion Criteria:

* History of clinically significant hypoglycaemia (low blood sugar levels)
* Women who are pregnant or breastfeeding

Primary outcomes:
measure: Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin
timeFrame: Multiple timepoints during 9 days
Secondary outcomes:
measure: Pharmacokinetic variables for saxagliptin's active metabolite BMS-510849 after single and multiple oral doses of 5 mg saxagliptin
timeFrame: Multiple time points during 9 days
measure: Safety variables (adverse events reported, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests after single and multiple oral doses of 5 mg saxagliptin
timeFrame: Multiple time points during 10 days (including measurements before dosing)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Peter Öhman, MD, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Deborah Price, MSc
role: STUDY_CHAIR
References:
citation: Li H, Yang L, Tou CK, Patel CG, Zhao J. Pharmacokinetic study of saxagliptin in healthy Chinese subjects. Clin Drug Investig. 2012 Jul 1;32(7):465-73. doi: 10.2165/11598760-000000000-00000.
Clinical trial NCT01594502: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
Official title: R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate cancer
dutasteride
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-05-09
Enrollment: 139
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Probability Sample

Brief summary: The goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer among men with negative biopsies.


Eligibility criteria: Inclusion Criteria:

* completed REDUCE trial (Year 4 exit biopsy with blocks and HE slides available; i.e., U.S. participants only)
* compliant with assigned treatment based on either: (dutasteride group) at least 3 post-baseline serum DHT levels ≥ 50% lower than baseline, or (placebo group) at least 3 post-baseline serum DHT levels with none showing ≥ 50% decrease from baseline

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue.
timeFrame: Year 4
Secondary outcomes:
measure: Multivariable treatment-response score between subjects who develop PCa while on dutasteride and those who do not.
timeFrame: Year 4
measure: Magnitude of association between nuclear phenotype in benign biopsies, and subsequent risk of PCa in untreated men at elevated risk.
timeFrame: Year 4
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Peter H Gann, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03046602: Parental Real-life Experience During the Neonatal Transfer
Official title: Parental Real-life Experience During the Neonatal Transfer From Intensive Care Unit to Maternity Service of St Joseph Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatology
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every new born child transfered to St Joseph neonatology service

Brief summary: The transfer of newborn child from Intensive Care Unit to maternity is very stressfull for parents.This anxiety could have repercussion on parents adaptation on their new environment, on parent's role and also on their relaional interaction with the baby. As StJoseph hospital receives an important number of premature babies, the neonatology service aim to evaluate the real life experience of mothers during the transfer to set up improvement axes with hospital departments upstream.


Eligibility criteria: Inclusion Criteria:

* new born child transfered to St Joseph neonatology service
* Having stayed at least five days Intensive Care Unit
* Regardless of the term
* have to stay at least five days in neonatology

Exclusion Criteria:

* Non francophones parents
* Duration of predictable hospitalization of less than 5 days

Primary outcomes:
measure: mother's real life experience assessment during the transfer of new born child from intensive care unit to neonatology
timeFrame: day 3 to 5
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: CRC- GHPSJ
name: Hélène BEAUSSIER, Pharm-D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06167902: The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial
Official title: The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 200
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: TREATMENT

Brief summary: To investigate the effect of ginseng oligopeptide on nonalcoholic fatty liver disease with obesity and clarify its intervention mechanism in theory, which will contribute to the prevention and treatment of non-alcoholic fatty liver more scientifically and effectively.The patients were randomly divided into two groups. One group of patients took ginseng oligopeptide orally, and the other group took placebo. The liver function, blood lipid, blood glucose, liver B ultrasound and other indicators were observed to further determine the efficacy.


Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria for non-alcoholic fatty liver disease ;
* Aged 18-65 years old;
* ALT, AST, GGT≤2×Upper Limit Of Normal（ULN）;
* BMI≥28Kg/㎡;
* Patients signed the relevant informed consent on a voluntary basis.

Exclusion Criteria:

* Under 18 years old and over 65 years old;
* Allergic to the ingredients of ginseng oligopeptide preparation;
* Serum ALT, AST, GGT\>2ULN;
* Currently taking oral hepatoprotective drugs such as reduced glutathione, polyene phosphatidylcholine, and silibinin, etc.;
* Subjects participating in other clinical trials;
* Pregnant or lactating women;
* Complicated with serious diseases of the digestive system or other systems, such as chronic gastrointestinal diseases and chronic diseases causing digestive malabsorption,Kidney disease, hematological system or autoimmune diseases;
* Other populations that were deemed by the investigators to be ineligible for the trial may reduce or complicate enrollment patients with chemotherapy.

Primary outcomes:
measure: Alanine aminotransferase (ALT)
timeFrame: The day of enrollment, day 60 and day 120 after enrollment.
measure: aspartate aminotransferase (AST)
timeFrame: The day of enrollment, day 60 and day 120 after enrollment.
measure: glutamyltransferase (GGT).
timeFrame: The day of enrollment, day 60 and day 120 after enrollment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03704402: Effect of High School Alcohol Policies on Students' Binge Drinking- a Natural Experiment
Official title: Effect of High School Alcohol Policies on Students' Binge Drinking- a Natural Experiment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcohol Policy
Binge Drinking
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consist of high school students participating in the Danish National Youth Study 2014 and the Danish National High School Study 2019

Brief summary: The aim of the project is to evaluate the effects of the introduction of new mutual alcohol policies in 30 high schools in 2017 on students binge drinking.

Detailed description: In August 2017, 13 high schools in Zealand and all of Funen's 11 high schools and 6 high schools in Ringkøbing introduced new mutual alcohol policy for alcohol on study trips, parties, cafes and other social events.

The background for the introduction of the alcohol policies was the aim of reducing alcohol intake among students and that alcohol should have a less dominant role. By setting the same framework, the alcohol policies aims at promoting community, responsibility and respect.

The aim of the project is to evaluate the effects of the introduction of new mutual alcohol policies on students binge drinking.

The analysis is a natural experiment that compare binge drinking among students at schools after the introduction of the policy with binge drinking among students a schools that did not introduce the policy.

Eligibility criteria: Inclusion Criteria:

* High school student

Exclusion Criteria:

-

Primary outcomes:
measure: Binge drinking 4 or more times within the last month
timeFrame: january 2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Southern Denmark University
name: Veronica Pisinger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06366802: Cohort Construction and Prognostic Model Construction for Multiple Myeloma
Official title: Cohort Construction and Prognostic Model Construction for Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed MM patients admitted to the First Affiliated Hospital of Soochow University

Brief summary: Multiple myeloma (MM) is a disease caused by malignant plasma cell proliferation disorder. Survival outcomes continue to vary widely even within uniformly treated clinical trial populations. How to construct a clinical prognosis model of MM through real-world data to guide the selection of treatment options, standardize patient management, and improve survival expectations, is a major problem that needs to be solved urgently. It is necessary to build an MM-specific cohort in China to comprehensively understand the characteristics of MM patients, explore treatment options, and improve prognostic factors for survival outcomes.


Eligibility criteria: Inclusion Criteria:

Patients were diagnosed as multiple myeloma from January 1, 2008 (the diagnostic criteria are based on "Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised in 2020)").

Exclusion Criteria:

Long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Progression free survival(PFS)
timeFrame: 5years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT06517602: Effect of Moringa Oleifera Leaves on Glycemic Control of Women With Type 2 Diabetes
Official title: Effect of Daily Consumption of Moringa Oleifera Leaves on Glycemic Control of Saharawi Women With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Moringa oleifera
Type 2 diabetes
Humans
Glucose
HbA1c
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial was to understand whether supplementation of Moringa oleifera leaf powder improved glycemic management in Sahrawi women with type 2 diabetes living in refugee camps. The main question sought to be answered was:

- Does daily supplementation of Moringa oleifera leaf powder, in addition to oral hypoglycemic therapy, improve glycosylated hemoglobin and fasting blood glucose?

Researchers compared Moringa supplementation with no Moringa consumption to see if Moringa oleifera worked to improve glycemic control.

Participants had to:

* Take Moringa oleifera leaves daily or abstain from consuming Moringa for 3 months.
* Consistently take prescribed oral hypoglycemic agents
* Undergo clinical examinations and measurement of biochemical, metabolic and body composition parameters at the time of recruitment and at the end of the study.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes for at least 1 year
* Absence of advanced retinopathy, terminal renal failure, active diabetic ulcers, amputations, and heart failure
* Treatment with only oral hypoglycemic drugs.

Exclusion Criteria:

* Diagnosis of type 1 diabetes
* Pregnancy or lactation
* Treatment with insulin.

Primary outcomes:
measure: Glycosylated hemoglobin (HbA1c)
timeFrame: Glycosylated hemoglobin was measured at recruitment and at the end of the study (three months)
measure: Fasting glucose
timeFrame: Fasting glucose was measured at recruitment and at the end of the study (three months)
Secondary outcomes:
measure: BMI
timeFrame: BMI were measured at recruitment and at the end of the study (3 months)
measure: Waist circumference
timeFrame: Waist circumference were measured at recruitment and at the end of the study (3 months)
measure: Hip circumference
timeFrame: Hip circumference were measured at recruitment and at the end of the study (3 months)
measure: % body fat
timeFrame: % of body fat were measured at recruitment and at the end of the study (3 months)
measure: Blood pressure
timeFrame: Systolic and diastolic blood pressure were measured at recruitment and at the end of the study (3 months)
Other outcomes:
Locations:
city: Tindouf
country: Algeria
facility: Dispensaris of Edchedería, Bir Lehlu, Mahbes, and Farsia (Smara camp)
Study officials:
References:
Clinical trial NCT00741702: Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples
Official title: Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes Mellitus
Keywords: Hypertension
Type 2 diabetes
First Nations populations
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Pfizer
First posted: 2008-08-26
Enrollment: 95
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 randomized controlled trial was designed to assess whether a community-based treatment strategy implemented by home care nurses would be effective in controlling hypertension in First Nations people with existing hypertension and type 2 diabetes.

Detailed description: Two community-based strategies for controlling hypertension in First Nations people with existing hypertension and diabetes were compared. In the intervention group, a home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. In the control group, treatment decisions were made by each subject's primary care physician. The primary outcome measure was the difference between the 2 groups in teh change in systolic blood pressure after 12 months.

Eligibility criteria: Inclusion Criteria:

* Age\>= 18 yr
* Type 2 diabetes mellitus
* Persistent hypertension (systolic pressure \>= 130 mmHg, diastolic pressure \>= 80 mm Hg, or both)

Exclusion Criteria:

* use of beta blocker
* women of child-bearing age not able to use a reliable method of birth control
* Connective tissue disorder
* Severe systemic or malignant disease
* Inability to follow the protocol
* Bilateral renal artery stenosis and other causes of secondary hypertension
* Serum creatinine level \> 250 micromol/L
* cerebrovascular even within 6 mo
* valvular heart disease
* unstable angina
* Myocardial infarction
* Revascularization procedure within 3 mo before study recruitment
* heart failure
* cardiac arrhythmia requiring medical treatment or heart block
* active hepatic disease

Primary outcomes:
measure: systolic blood pressure
timeFrame: 12 months
Secondary outcomes:
measure: Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Sheldon Tobe, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06850402: Evaluation of a Novel Optical Microscope With a Deep Depth of Field (DeepDOF) to Provide Histologic-quality Images on Cervical Biopsies and Loop Electrosurgical Excision Procedure (LEEP) Specimens at the Point-of-care
Official title: Evaluation of a Novel Optical Microscope With a Deep Depth of Field (DeepDOF) to Provide Histologic-quality Images on Cervical Biopsies and Loop Electrosurgical Excision Procedure (LEEP) Specimens at the Point-of-care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Cancer
HIV
Keywords: HPV DNA Testing
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 400
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: All patients will be enrolled in Mozambique and Brazil. They will provide informed consent to use their cervical biopsy and/or LEEP specimens for imaging with DeepDOF prior to sending for standard of care processing and interpretation.

Detailed description: Primary Objectives:

1. Evaluate the diagnostic performance of the DeepDOF digital histopathology platform compared with standard histopathology in cervical biopsies and/or LEEP specimens.
2. Compare performance characteristics between WLWH and HIV-negative women.

Secondary Objectives:

1. Evaluate the ability of pathologists to provide a diagnostic evaluation of cervical biopsies and LEEP margins using digital DeepDOF images.
2. Develop DeepDOF algorithms for automated diagnostic evaluation of cervical biopsies and LEEP margins.

Eligibility criteria: Inclusion Criteria:

1. Women aged 25 - 49 years
2. women undergoing cervical biopsy and/or LEEP
3. Women who are not pregnant and with a negative pregnancy test (within 3 days of enrollment)
4. Willing and capable of providing informed consent

Exclusion Criteria:

1. Women under 25 or over 49 years of age
2. Women not undergoing cervical biopsy or LEEP
3. Women who are pregnant

Primary outcomes:
measure: Primary Out Measures
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas M. D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathleen M Schmeler, MD
role: PRINCIPAL_INVESTIGATOR
References: