louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00532506: Phase II Dose-Finding Study of SK-0403 With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-09-20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in patients with Type2 Diabetes Mellitus


Eligibility criteria: Inclusion Criteria:

* Treatment-naive subjects diagnosed with type 2 diabetes mellitus
* Stable diet program for at least 8 weeks
* Criteria for HbA1c are met

Exclusion Criteria:

* Type 1 diabetes
* Patients treated with other antidiabetic drugs or Insulin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Gunma
country: Japan
city: Hokkaido
country: Japan
city: Ibaragi
country: Japan
city: Kanagawa
country: Japan
city: Kumamoto
country: Japan
city: Oita
country: Japan
city: Okinawa
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism
name: Ryuzo Kawamori, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03916406: THE EFFECT OF MULTIPLE DOSES OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL MIDAZOLAM DOSE IN HEALTHY PARTICIPANTS
Official title: A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF REPEATED DOSING OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF MIDAZOLAM IN HEALTHY PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a Phase 1, randomized, open label, 2 way crossover drug drug interaction (DDI) study which will evaluate the impact of PF 06835919 on midazolam pharmacokinetics in healthy participants. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of approximately 10 healthy male and/or female participants will be enrolled in this study so that approximately 5 participants will be enrolled into each treatment sequence. In this crossover study, 2 treatments are being assessed.


Eligibility criteria: Inclusion Criteria:

* Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed
* Participants, who according to the product label for midazolam, would be at increased risk if dosed with midazolam (ie, including but not limited to participants with history of myasthenia gravis, chronic obstructive pulmonary disease (COPD), pulmonary insufficiency, glaucoma, concomitant central nervous system (CNS) depressants).
* History of hypersensitivity to midazolam or any other benzodiazepine

Primary outcomes:
measure: AUCinf of midazolam following a single oral dose
timeFrame: Baseline up to 51 days
Secondary outcomes:
measure: AUClast of midazolam following a single oral dose.
timeFrame: Baseline up to 51 days
measure: Cmax of midazolam following a single oral dose.
timeFrame: Baseline up to 51 days
measure: Incidence of Adverse Events in participants
timeFrame: Screening up to 79 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Brussels Clinical Research Unit
state: Be-bru
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06473506: Group A Streptococcus Saliva Study
Official title: Exploring the Use of Saliva for the Detection of Group A Streptococcus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Group A Streptococcal Infections
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to evaluate whether saliva can be used to diagnose GAS infection and also to compare different testing methods in the microbiology lab. The saliva sample testing will be compared to the throat swab testing to see if saliva testing works as well. The lab will also try different testing methods to see if a faster type of testing (e.g. molecular testing) works as well as the regular method, which takes 48 hours to get results.

This is important because throat swabs can be challenging to collect in some children, and saliva is often much easier and more acceptable by children to collect. This could improve our ability to accurately diagnose and treat GAS infections.


Eligibility criteria: Inclusion Criteria:

* \< 19 years of age
* Have provided a sample for GAS testing (bacterial throat swab or POCT rapid antigen test) at the discretion of the clinical team
* Able to provide a saliva sample

Exclusion Criteria:

* Parent/guardian and/or patient unable to consent or assent
* Unable to provide a saliva sample

Primary outcomes:
measure: Rate and sensitivity of GAS detection
timeFrame: Within 24 hours of collection
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Monica Caldeira-Kulbakas
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT01906606: Effectiveness of Parenting Programs on Child Development and Maternal Well-being in Rural Uganda
Official title: Effectiveness of Parenting Programs on Child Development and Maternal Well-being in Rural Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Depression
Keywords: child nutritional status
child development
maternal depression
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
First posted: 2013-07-24
Enrollment: 360
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the current study involves the development, implementation and evaluation of a parenting program to target maternal well-being and child health, growth and development in Lira, Uganda. The current study aims to address maternal care within a parenting program as well as parenting practices emphasizing nutrition, hygiene, and psychosocial stimulation through peer-support, practice and problem-solving. Outcomes include child health, growth and development, maternal mental health, mother-child interactions, and maternal-spousal relations.

We hypothesize that:

1. Children of parents who attend the parenting program will have better health, height and cognitive/language development at post-test, than children whose parents did not have the opportunity to attend parenting sessions.
2. Parents who attend the parenting program will have more knowledge about child development and provide more home stimulation, dietary diversity and preventive health practices than parents who do not have the opportunity to attend parenting sessions.
3. Mothers who attend the parenting program will have improved well-being compared to mothers who do not have the opportunity to attend parenting sessions.


Eligibility criteria: Inclusion Criteria:

* mothers of children ages 12-24 months

Exclusion Criteria:

* disabled children

Primary outcomes:
measure: Change from baseline in Bayley III Language scale
timeFrame: Baseline and 11 months
Secondary outcomes:
measure: Change from baseline in CES-D
timeFrame: Baseline and 11 months
Other outcomes:
measure: Change from Baseline in child length-for-age
timeFrame: Baseline and 11 months
Locations:
city: Lira
country: Uganda
facility: Lira Program Unit, Plan Uganda
Study officials:
affiliation: McGill University
name: Frances Aboud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singla DR, Kumbakumba E, Aboud FE. Effects of a parenting intervention to address maternal psychological wellbeing and child development and growth in rural Uganda: a community-based, cluster randomised trial. Lancet Glob Health. 2015 Aug;3(8):e458-e469. doi: 10.1016/S2214-109X(15)00099-6. Epub 2015 Jul 2.
Clinical trial NCT02947906: Plantar Pressure Distribution in Patient With Multiple Sclerosis
Official title: Investigating the Plantar Pressure Distribution in Patient With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Gait
Loading
Multiple Sclerosis
Plantar Pressure
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with multiple sclerosis

Brief summary: Fifty patients who were referred to receive physiotherapy and 20 healthy volunteers will be participants of the study.Participants with multiple sclerosis will evaluate with the following assessment tools: Modified Ashworth scale will use to evaluation of severity of plantar flexor spasticity. Plantar pressure distribution parameters will assess with dynamic pedobarography.

Detailed description: Fifty patients who were referred to receive physiotherapy at the neurology department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Hacettepe University, Ankara with multiple sclerosis and twenty voluntary healthy age matched participants will be the subjects of this study.

Assessment tools described as following: Modified Ashworth scale will use to evaluate of severity of plantar flexor spasticity. Static and dynamic loading parameters will be evaluate with pedobarography.Maximum loading pressure -N/cm2, maximum loading time- ms for; 1st. and 5th metatarsal head, medial and lateral heel and midfoot will be recorded both while the patients standing and walking.

Eligibility criteria: Inclusion Criteria:

* Want to participate Individuals with multiple sclerosis who can walk alone for 30 meters Healthy participants who diagnosed no disorders or orthopedic problems.

Exclusion Criteria:

* Want to participate Individuals with multiple sclerosis who can walk alone for 50 meters Healthy participants who diagnosed no disorders or orthopedic problems.

Primary outcomes:
measure: Pedobarography for assessment of foot pressure while standing and walking
timeFrame: Initially evaluation at first minute, Change from initial evaluation to 20th minutes, Change from initial evaluation to 24 hours, Change from initial evaluation to 24 hours and 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00489606: Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530
Official title: Clinical Trial to Investigate the Influence of Drug Interaction After Oral Administration of Tamsulosin and SK3530 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Keywords: SK3530
tamsulosin
hemodynamic interaction
safety
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-06-21
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and tamsulosin, phase I study in healthy volunteers was designed.

Detailed description: During each of the two periods of a randomized, double-blind, placebo-controlled, crossover study, 16 healthy men received tamsulosin 0.2 mg daily for 7 days and either a single 100 mg of SK3530 or placebo on day7. The blood pressure and heart rate were monitored before and for 24 hours after SK3530 or placebo.

Eligibility criteria: Inclusion Criteria:

* ages 20 to 50
* body weight of IBM±20%

Exclusion Criteria:

* cardiovascular disease
* color-blindness or weakness
* hypotension, hypertension, orthostatic hypertension
* abmormal QTc (\>430 ms)

Primary outcomes:
measure: Maximal decrease from baseline in supine SBP
timeFrame: within 6 hrs after SK3530 or placebo
Secondary outcomes:
measure: Maximal decrease from baseline in standing SBP, supine/standing DBP & HR
timeFrame: within 6 hrs after SK3530 or placebo
measure: Outlier analysis: i) Standing/supine SBP < 85 mmHg, DBP < 45 mmHg; ii) Change in standing/supine SBP > 30 mmHg, DBP > 20 mmHg
timeFrame: within 6 hrs after SK3530 or placebo
measure: Incidence of postural hypotension
timeFrame: within 6 hrs after SK3530 or placebo
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00506506: Effect of N-Acetylcysteine (NAC) on Creatinine in Chronic Kidney Disease
Official title: Randomized Controlled Trial Examining the Effect of N-Acetylcysteine on Serum Creatinine in Patients With Stage 3 Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: N-acetylcysteine
Chronic kidney disease
eGFR
Cystatin C
proteinuria
Stage 3 chronic kidney disease
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2007-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: N-acetylcysteine is used to reduce the risk of injury to the kidney after the administration of contrast dye. The mechanism and effectiveness of this intervention is not substantiated in the literature. The investigators hypothesize that serum creatinine will be lower in patients who receive NAC compared to those who receive the placebo but serum cystatin C will not change in patients who receive NAC compared to those who receive the placebo. Also urine creatinine will increase after the administration of NAC compared to before the administration of NAC.


Eligibility criteria: Inclusion Criteria:

1. Patients with an eGFR between 30-60 ml/min calculated using last available creatinine and patient weight.
2. Age \> 18
3. No known allergies to or adverse effects from NAC
4. No known scheduled radio-contrast procedures
5. No medications known to affect creatinine secretion

Primary outcomes:
measure: 24 hour creatinine clearance, estimated glomerular filtration rate (eGFR), proteinuria and cystatin C
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Schulich School of Medicine and Dentistry, University of Western Ontario
name: Louise Moist, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moist L, Sontrop JM, Gallo K, Mainra R, Cutler M, Freeman D, House AA. Effect of N-acetylcysteine on serum creatinine and kidney function: results of a randomized controlled trial. Am J Kidney Dis. 2010 Oct;56(4):643-50. doi: 10.1053/j.ajkd.2010.03.028. Epub 2010 Jun 11.
Clinical trial NCT00604006: SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
Official title: SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: Prevention of heart failure in individuals at high risk
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: National Heart Foundation, Australia
First posted: 2008-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Individuals who were a part of the investigators Screen-HF study (NCT00400257) whose BNP level are in the top quintile will be offered participation in this study. Participants will be randomised to receive either spironolactone or placebo for three years. Participants will then be monitored for indications of heart failure. It is anticipated that the medication will reduce the development of heart failure in this group.


Eligibility criteria: Inclusion Criteria:

1. Was recruited to SCREEN-HF
2. Has provided informed consent

Exclusion Criteria:

1. Uncorrected hyperkalaemia
2. eGFR \< 30 ml/min

Primary outcomes:
measure: Effectiveness of Spironolactone in preventing heart failure
timeFrame: 1 year and 3 year
measure: Cost effectiveness of Spironolactone prevention
timeFrame: 3 years
Secondary outcomes:
measure: Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure
timeFrame: 1 year and 3 year
measure: Change in 6 minute walk test between the two groups
timeFrame: 1 year and 3 years
measure: Change in quality of life between the two groups
timeFrame: 1 year and 3 year
measure: Change in left ventricular remodelling parameters
timeFrame: 1 year and 3 years
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Monash University / Alfred Hospital
name: Henry Krum, MBBS FRACP PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell DJ, Coller JM, Gong FF, McGrady M, Boffa U, Shiel L, Liew D, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL. Kidney age - chronological age difference (KCD) score provides an age-adapted measure of kidney function. BMC Nephrol. 2021 Apr 26;22(1):152. doi: 10.1186/s12882-021-02324-y.
citation: Gong FF, Jelinek MV, Castro JM, Coller JM, McGrady M, Boffa U, Shiel L, Liew D, Wolfe R, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL, Campbell DJ. Risk factors for incident heart failure with preserved or reduced ejection fraction, and valvular heart failure, in a community-based cohort. Open Heart. 2018 Jul 23;5(2):e000782. doi: 10.1136/openhrt-2018-000782. eCollection 2018.
Clinical trial NCT02024906: Effect of Soy Intake on Cardiovascular Disease Biomarkers in Subclinical Hypothyroid Participants
Official title: Effect of Soy Intake on Cardiovascular Disease Biomarkers in Subclinical Hypothyroid Participants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Disease
Subclinical Hypothyroid
Keywords: isoflavone
CVD
soy intake
subclinical hypothyroid
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Soy Nutrition Institute
First posted: 2013-12-31
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
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 help the researchers understand if using a soy supplement impacts cardiovascular disease risk factors in patients with subclinical hypothyroidism.

Detailed description: This pilot trial is a double blind, randomized, parallel arm trial. Eighty participants with subclinical hypothyroidism will be randomized to consume either soy protein isolate or milk protein isolate for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with subclinical hypothyroidism (otherwise healthy volunteers)
* Adults aged 25 - 70 yrs.
* Willing to avoid consumption of soy/other isoflavone containing foods (i.e. some snack bars) during the study.
* Willing to avoid consumption of dietary (other than multivitamin) and herbal supplements during the study.

Exclusion Criteria:

* Taking drugs that interfere with thyroid function
* Planning pregnancy in the next 6 months
* Taking drugs that lower lipids, blood pressure, or sensitize insulin
* Regular consumption of soy products (\>20 g/wk)
* Consumption of soyfoods within 90 days prior to enrollment.
* Known history of soy or milk allergy or intolerance.
* Taking antibiotics during the intervention
* Active viral infections such as Human immunodeficiency virus (HIV) positive or hepatitis

Primary outcomes:
measure: Changes in the cardiometabolic profile
timeFrame: Change from Baseline to Week 8
Secondary outcomes:
measure: Change in thyroid function
timeFrame: Change from Basesline to 8 Weeks
measure: Change in thyroid function
timeFrame: Change from Basesline to 4 Weeks
measure: Changes in the cardiometabolic profile
timeFrame: Change from Basesline to 4 Weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jill Hamilton-Reeves, PhD, RD, LD
role: PRINCIPAL_INVESTIGATOR
References: