louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02449187: Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Hyperlipidemia
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-20
Enrollment: 16
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single dose, crossover study to investigate the effect of food on the pharmacokinetics of JLP-1310 in healthy male volunteers.

Detailed description: A randomized, open-label, single dose, crossover clinical trial.

Eligibility criteria: Inclusion Criteria:

1. Healthy male volunteer, age is over 19 years
2. Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
3. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
4. Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Subjects who are allergic to investigational drug.
3. Subjects who have a medical history which can affect the clinical trial.
4. Hypertension(Systolic BP ≥ 140mmHG or Diastolic BP ≥ 90mmHg), Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
5. History of drug abuse or positive drug screening.
6. Participation in other drug studies within 3 months prior to the drug administration.
7. Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Primary outcomes:
measure: Cmax
timeFrame: 48 hours from baseline
measure: AUC(last)
timeFrame: 48 hours from baseline
Secondary outcomes:
measure: AUC(inf)
timeFrame: 48 hours from baseline
measure: Tmax
timeFrame: 48 hours from baseline
measure: T1/2
timeFrame: 48 hours from baseline
measure: CL/F
timeFrame: 48 hours from baseline
measure: Vd/F
timeFrame: 48 hours from baseline
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Inha University Hospital
name: Sang Heon Cho, MD., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01054287: Falls Prevention in Acute Care Hospital
Official title: Falls Prevention Program in Acute Care Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Falls
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2010-01-22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The aim of this study is to evaluate the effect of a multifactorial falls prevention program in an acute internal medicine ward.


Eligibility criteria: Inclusion Criteria:

* all patients admitted to internal medicine ward

Exclusion Criteria:

* none

Primary outcomes:
measure: falls rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Service of internal medicine, CHUV
state: Vaud
Study officials:
References:
Clinical trial NCT05357287: Closed Incisional Negative Pressure Wound Therapy in Post-surgical Wound Care of Patients With Periprosthetic Joint Infection
Official title: Closed Incisional Negative Pressure Wound Therapy in Post-surgical Wound Care of Patients With Periprosthetic Joint Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Heal
Periprosthetic Joint Infection
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the proposed study, we will apply Prevena on the surgical wound right after closure of the wound in the operating theater. Prevena will be used for 7 days, unless there is ongoing infection or much wound drainage that requires debridement.

Most periprosthetic joint infections are from hematogenous origin. Hence, it is considered clean wound unless there is a discharging sinus.


Eligibility criteria: Inclusion Criteria:

1. patients with periprosthetic joint infection
2. indicated for debridement surgery
3. high risk for wound complication, including one of the followings: diabetes mellitus, use anticoagulants other than aspirin, current smoker, on immunomodulators or steroids, malnutrition, liver disease, renal failure, BMI \> 35 kg/m2

Exclusion Criteria:

1. previous flap surgery on the indexed joint
2. younger than 18 years of age
3. silver allergy

Primary outcomes:
measure: wound complication
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT00198887: Operations Research to Improve Newborn Health
Official title: Operations Research to Improve Newborn Health and Survival in the (INHP-II) Area of CARE/India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complications
Keywords: newborn
operations research
newborn survival
Neonatal illness/mortality
Delivery complications
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 59651
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study is designed to look at how operations are carried out in relation to improving the health and survival of newborn babies in India.

Detailed description: The proposed study aims to evaluate the impact of a basic package of obstetric and neonatal care practices implemented by CARE-India as part of their ten-year, two-phase Integrated Nutrition and Health Program (INHP). Building on the lessons learned from the Integrated Nutrition and Health Project I (INHP I) in seven Indian states during 1996-2001, CARE-India has designed INHP II, which focuses on six technical interventions. CARE-India aims to implement this program in 100,000 villages across eight states of India by the year 2006. One of the technical interventions is a focused package of newborn care to be implemented at the community level to improve the health and survival of the newborns, including improvements in care-seeking for maternal and newborn conditions. The services and behaviors promoted include:

1. antenatal care,
2. iron-folate supplementation,
3. tetanus toxoid vaccination,
4. maternal nutrition and rest,
5. birth planning,
6. essential newborn care,
7. immediate and exclusive breastfeeding,
8. prevention of hypothermia,
9. aseptic cord care, and
10. identification and referral of cases with danger signs for both pregnancy/delivery complications and newborn conditions.

The services are provided by first-line community-based health workers.

CARE-India invited Johns Hopkins Bloomberg School of Public Health (JHBSPH) to help evaluate their newborn program in an operations research mode. JHBSPH's role is limited to assisting CARE with the design and evaluation of newborn intervention.

Eligibility criteria: Inclusion Criteria:

* Newborn

Exclusion Criteria:

* Infant/child

Primary outcomes:
measure: Neonatal mortality rate
Secondary outcomes:
measure: Cost of delivering the intervention, per newborn
measure: Changes in behavioral indicators
measure: Change in program coverage
Other outcomes:
Locations:
city: Lucknow
country: India
facility: King George's Medical College
state: Uttar Pradesh
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Mathuram Santosham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02709187: DP-R208 Pharmacokinetic Study
Official title: DP-R208 Pharmacokinetic Study Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: DP-R208
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2016-03-15
Enrollment: 37
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* BMI 18\~30
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Previously donate whole blood within 60 days or component blood within 14 days
* Clinically significant allergic disease
* Taken IP in other trial within 90 days
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: up to 48 hours post dose
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to 48 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00873587: Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal
Official title: Randomized Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Tube Removal
Keywords: Thoracotomy
Inspiration
Expiration
Chest Tube
pneumothorax
Method of chest tube removal
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-04-01
Enrollment: 342
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are two commonly used methods to remove chest tubes following thoracotomy. One is to remove the chest tube at maximum inspiration, (patient is asked to take a deep breath in and hold it), and the other is to pull the chest tube at maximum expiration,(patient is asked to blow out as much air as they can can and hold it). There has been considerable discussion among Thoracic surgeons that one of these two methods may decrease the risk of pneumothorax, the most common complication associated with chest tube removal. The investigators will compare the two methods, and also identify risk factors of developing pneumothorax during chest tube removal.


Eligibility criteria: Inclusion Criteria:

* Patients who are post thoracotomy, pulmonary resection (wedge, lobectomy, segmentectomy, pneumonectomy), AND
* Have at least one chest tube.

Exclusion Criteria:

* Less than 19 years old,
* With interstitial lung disease, OR
* Any patient intubated.

Primary outcomes:
measure: Pneumothorax
timeFrame: Within 4 hours after chest tube removal
Secondary outcomes:
measure: Morbidity
timeFrame: 4 hours after chest tube removal
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham, Department of Surgery
name: Robert J Cerfolio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01583387: Effect of Water Intake on the DNA Adducts Formation
Official title: Proof of Concept of the Effect of Water Intake on the DNA Adducts Formation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: healthy adults
urinary adducts
water intake
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2012-04-24
Enrollment: 65
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of the study is to assess the effect of water intake on the formation of 4-ABP DNA adducts.


Eligibility criteria: Inclusion Criteria:

* Male subjects 20 to 45 years old (bound included)
* Smoker with at least 15 cigarettes/day
* Subjects with body mass index between 18 and 27kg/m2 (bound included)
* Subjects with a 3-meal diet (breakfast, lunch, dinner)
* Subjects who have an easy daily access to internet
* Subjects able to communicate well with the investigator and willing to comply the requirement of the study
* Subjects who have signed the form of informed consent and are registered to the French national welfare system

Exclusion Criteria:

* Subjects presenting evidence or history of severe or acute disease which could affect the results of the study or the vital status
* Subject practising physical activity in an intensive way according to the investigator judgment.
* Subject with a history of metabolic disease or with acute or chronic gastrointestinal disease except appendicectomy
* Subjects with diagnosed urinary tract disease
* Subjects with diagnosed lung or respiratory disease
* Subjects consuming regularly more than 3 units of alcohol per day
* Subjects who take drugs or presenting drug addiction (cannabis, opioids, amphetamines.)
* Subjects presenting a situation interfering with the outcomes of the study according to the investigator opinion
* Subjects working with painting, dry cleaning, dyes, pesticides, aluminium or alphalt
* Subjects who eat charcoaled food more than three meals/week
* Subjects with a vegetarian diet
* Subjects under local or general treatment which can modify measurements performed in the study, in particular the assessment of the hydration status (diuretic intake, or treatment interfering with metabolism and nutrition behaviour)
* Subjects planning to stop or reducing smoking or change their cigarette brand within the next 3 months
* Subjects in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject
* Subjects currently in a exclusion period following participation in another clinical trial
* Subjects having received 4500 euros indemnities for participation in clinical trials in the 12 previous months (including participation in the present study)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre CAP
Study officials:
References:
Clinical trial NCT00257387: Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants
Official title: A Nonrandomized, Open-label, Multicenter, Sequential Phase Study to Evaluate the Safety and Efficacy of Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese De Novo Renal Allograft Recipients Receiving Rapamune
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Kidney Transplant
Keywords: Kidney
Kidney Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Evaluate the incidence of acute rejection at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.


Eligibility criteria: Inclusion Criteria:

* Subjects with end-stage renal disease scheduled to receive a primary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor.
* Subjects must be at least 18 years of age.

Exclusion Criteria:

* Subjects with active major infection, including active hepatitis B or C infection, HIV, decreased platelets, elevated lipids, or multiple organ transplants.

Primary outcomes:
measure: The incidence and severity of acute rejection in renal allograft recipients at 6 months post-transplantation.
Secondary outcomes:
measure: To evaluate the treatment groups with respect to incidence of adverse events, renal function, subject and graft survival at 6 and 12 months, and the incidence and severity of acute rejection at 12 months post-transplantation.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03499587: Effects of Maternal Obesity on Offspring Brain Development
Official title: Effects of Maternal Obesity on Offspring Brain Development
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant healthy volunteers

Brief summary: The goal of this study is to see if there are negative effects of maternal obesity during pregnancy on offspring's brain development.

Detailed description: This study will recruit pregnant women who are either obese or normal weight and otherwise healthy. We will measure their body composition, food intake and other characteristics during pregnancy. When their babies are born, we will evaluate the brain development of their babies using magnetic resonance imaging and electroencephalography at age two weeks. We will then compare the findings and see if their are differences.

Eligibility criteria: Inclusion Criteria:

* BMI 18.5-25 or \>30 with early OB visit medical records accessible
* singleton pregnancy
* about 36wks of pregnancy
* at least 18 years of age

Exclusion Criteria:

* hypertension, diabetes, or other preexisting medical conditions
* medications known to influence fetal growth
* recreational drugs, nicotine or tobacco use of alcohol use while pregnant
* pregnancy conception with assisted fertility treatment
* medical complications developed during pregnancy

Primary outcomes:
measure: Determine whether maternal obesity correlates with abnormal brain development in newborns
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
References:
Clinical trial NCT06026787: Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome
Official title: Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nephrotic Syndrome
Sodium-Glucose Transporter 2 Inhibitors
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 60
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: Conducted as a randomized controlled clinical trial, this study aims to assess the potential benefits of incorporating dapagliflozin, an SGLT-2 inhibitor, into the treatment regimen of patients diagnosed with primary nephrotic syndrome. The primary focus is on examining the impact of dapagliflozin on two key parameters: proteinuria and estimated glomerular filtration rate (eGFR).

The trial involves adult participants who have been definitively diagnosed with primary nephrotic syndrome through renal biopsy. In conjunction with their standard care, these participants will receive a daily dose of dapagliflozin at 10 mg. Over a span of six months, they will undergo comprehensive monthly assessments. These assessments will involve the collection and analysis of urine samples to quantify proteinuria and perform urinalysis. Additionally, blood samples will be taken to determine the estimated eGFR, lipid profile, glycated hemoglobin. Participants will also be encouraged to report any potential side effects resulting from their medication intake.


Eligibility criteria: Inclusion Criteria:

* eGFR \> 25 mL/min/1.73m2
* Evidence of primary nephrotic syndrome by renal biopsy
* Non-diabetic kidney disease

Exclusion Criteria:

* Nephrotic syndrome secondary to lupus nephritis, AAV, amyloidosis, or secondary membranous nephropathy
* Hepatic impairment \[AST or ALT \>3 times ULN or total bilirubin \>2 times the ULN\] at the time of enrolment
* Pregnant or breast-feeding females

Primary outcomes:
measure: Proteinuria
timeFrame: 6 months
measure: Estimated GFR
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Lipid profile
timeFrame: 6 months
measure: Body Weight
timeFrame: 6 months
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References: