louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01768455: Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male Subjects
Official title: A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Gemigliptin and Glimepiride in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2013-01-15
Enrollment: 27
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study was to investigate the pharmacokinetic drug interaction between gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly and each alone.


Eligibility criteria: Inclusion Criteria:

* Age between 20 to 45, healthy male subjects (at screening)
* BMI between 18 - 27 (at screening)
* FPG 70-125mg/dL glucose level (at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(gemigliptin, glimepiride, aspirin, antibiotics)
* Subject who already participated in other trials in 90 days
* Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently

Primary outcomes:
measure: AUC
timeFrame: up to 24h post-dose
measure: Cmax
timeFrame: up to 24h post-dose
Secondary outcomes:
measure: Tmax
timeFrame: up to 24h post-dose
measure: t1/2β
timeFrame: up to 24h post-dose
measure: AUC
timeFrame: up to 24h post-dose
measure: Cmax
timeFrame: up to 24h post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00417755: Effect of Invasive and Non Invasive Mechanical Ventilation on Feeding Delivery in COPD Elderly Patients
Official title: Effect of Invasive and Non Invasive Mechanical Ventilation on the Nutritional Status of COPD Elderly Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Mechanical Ventilation
Keywords: Nutritional intake
Mechanical ventilation
Enteral feeding
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2007-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: COPD patients requiring ventilation may benefit from invasive or non invasive ventilation. Non invasive ventilation is often incompatible with oral or enteral feding, due to gastric dilatation and full mask therapy. At the other hand, invasive ventilation is associated with incomplete enteral feeding and nutrition requirements are not reached. The aim of the study was to compare the feeding delivery of COPD patients receiving invasive or non invasive mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* COPD patients requiring mechanical ventilation (invasive and non invasive)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rabin Medical Center, Beilison Hospital, Israel
name: Pierre Singer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01843855: The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
Official title: The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Gastric Bypass
bariatric surgery
glucose metabolism
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Center for Research Resources (NCRR)
First posted: 2013-05-01
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of \> 110 mg/dL
* Subjects registered to receive a Roux-en-Y Gastric Bypass (RYGB).

Exclusion Criteria:

* Subjects taking thiazolidinediones
* Subjects with active systemic illness
* Subjects with active microvascular or macrovascular complications of their diabetes
* For female subject: positive pregnancy test at the time of enrollment in study

Primary outcomes:
measure: Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB)
timeFrame: baseline, 4 weeks post-operative intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01238055: Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer
Official title: Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Keywords: advanced gastric cancer
sunitinib
docetaxel
fluoropyrimidine platinum based chemotherapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 116
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: The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in the treatment of advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinum.

Detailed description: This is a randomized phase II trial of Sunitinib and Docetaxel in advanced gastric cancer patients who had prior chemotherapy with Fluoropyrimidine and Platinum.

Eligibility criteria: Inclusion Criteria:

1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with \> 50% extension in the stomach)
2. patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
3. prior chemotherapy wit fluoropyrimidine and platinum
4. measurable or evaluable disease according to RECIST
5. age, 18 years or older
6. ECOG performance status 0 - 2
7. adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 2.0 mg/dL
8. life expectancy of ≥ 3 months
9. signed written informed consent

Exclusion Criteria:

1. more than one prior chemotherapy for metastatic disease
2. severe co-morbid illness and/or active infections
3. NCI CTCAE Grade 3 hemorrhage from any cause \< 4 weeks before enrollment
4. preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart
5. pregnant or lactating women
6. active CNS metastases not controllable with radiotherapy or corticosteroids
7. active and uncontrollable bleeding from gastrointestinal tract
8. known history of hypersensitivity to study drugs
9. prior treatment with sunitinib

Primary outcomes:
measure: time to progression
timeFrame: every 6 weeks
Secondary outcomes:
measure: Response rate
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
measure: Progression free survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Seoul, Korea
name: Jeeyun Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01119755: Seasonal Variation of Ambulatory Blood Pressure
Official title: Seasonal Variation of 24hour Ambulatory Blood Pressure Monitoring in Treated Hypertensives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: TREATMENT OF HYPERTENSION
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2010-05-10
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TREATED HYPERTENSIVES REFERRED TO AN OUTPATIENT CLINIC

Brief summary: This is a prospective study to evaluate the change in 24 hour ambulatory blood pressure during winter and summer in well controlled treated hypertensives.

Detailed description: Two 24hour ambulatory blood pressure monitorings, 4 to 6 months apart, will be performed on hypertensive subjects on a stable antihypertensive drug therapy for at least 4 weeks.

The correlation of weather and temperature with the 24hour ambulatory blood pressure monitoring will be explored.

Eligibility criteria: Inclusion Criteria:

* Age \> 40 yrs
* Treated hypertension on stable treatment for at least 8 weeks
* Average home blood pressure (at least 5 days, 20 readings) \< 130/80 mmHg

Exclusion Criteria:

* Congestive heart failure
* Use of loop diuretics

Primary outcomes:
measure: Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter.
timeFrame: 1 year
measure: Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter
timeFrame: 1 year
measure: Mean Difference of Systolic Night-time Ambulatory Blood Pressure Between Summer and Winter
timeFrame: 1 year
measure: Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter
timeFrame: 1 year
Secondary outcomes:
measure: Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter
timeFrame: 1 year
measure: Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter
timeFrame: 1 year
measure: Mean Difference of Systolic Home Blood Pressure Between Summer and Winter
timeFrame: 1 year
measure: Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter
timeFrame: 1 year
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hypertension Center, Third Department of Medicine, University of Athens, Greece
Study officials:
affiliation: Hypertension Center,Third Department of Medicine,University of Athens,Greece
name: George S Stergiou, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04634955: S1 Transforaminal Injection and Vascular Incidence
Official title: Comparison of Intravascular Incidence With Different Fluoroscopic Approach Method During S1 Trasnforaminal Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inadvertent Arterial Puncture
Keywords: intravascular injection transforaminal injection
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 149
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intravascular incidence during S1 transforaminal injection is known to be higher than lumbar injection. Its incidence is reported to be 15\~25%.

This study was aimed to see if there is any benefit of reducing the intravasuclar injection rate when S1 transforaminal injection was performed by different fluorosopic approach.

Detailed description: Fluorosocpically guided transforaminal epidural steroid injection is a popular interventional procedure that is effective in radicular pain conditions such as herniated interverebral disc, spinal stenosis and failed back surgery syndrome.

The incidence of inadvertent intravascular needle injection during lumbar transforaminal injection is reported as from 9.9% to 30.8%. In particular, S1 intravascular injection rate is more frequent than at the lumbar level.

Previous study reported that guiding the needle toward the S1 foramen using the S1 scotty dog image as a bony landmark, not in the classic way, but in an oblique fluoroscopic view, during L5 and S1 transforaminal epidural steroid injection, can save procedure time and reduce the risk of radiation exposure.

In this stidy, the investigators aimed to compare the incidence of intravascular injection rate by anteroposterior and oblique view approaches for S1 transforaminal epidural steroid injection. In addition, the investigators also compared the procedure time and radiation exposure between two approach method.

Eligibility criteria: Inclusion Criteria:

* spinal stenosis
* herniated intervertebral disc
* failed back surgery syndrome

Exclusion Criteria:

* coagulopathy
* infection

Primary outcomes:
measure: intravascular incidence
timeFrame: 15 minutes after the completion of the intervention
Secondary outcomes:
measure: procedure time
timeFrame: 15 minutes after the completion of the intervention
measure: radiation dose
timeFrame: 15 minutes after the completion of the intervention
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong ji HEE
Study officials:
affiliation: Keimyung University
name: Ji Hee Hong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06313255: A Retrospective Observational Study on the Effects of Probiotics on HBsAg Clearance
Official title: A Retrospective Observational Study on the Effects of Probiotics on HBsAg Clearance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis B
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is patients with chronic hepatitis B who are receiving antiviral therapy with or without probiotics.

Brief summary: The goal of this retrospective observational study is to find out the effects of probiotics on HBV clearance. The main question it aims to answer is:

Are the probiotics have an effect in promoting HBV clearance? The participants will observe the HBV clearance rate in chronic hepatitis B patients receive probiotics in addition to the routine antiviral therapy.

Researchers will compare the HBV clearance rate in chronic hepatitis B patients receive probiotics and antiviral therapy with those receiving solely antiviral therapy.


Eligibility criteria: Inclusion Criteria:

* chronic hepatitis B patients

Exclusion Criteria:

* patients with malignancies
* patients with other liver diseases
* pregnancy patients

Primary outcomes:
measure: HBsAg clearance
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT03740555: A Study of HNC042 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics.
Official title: A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single and Multiple Ascending Doses (SAD/MAD) Study Following Intravenous Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of HNC042.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Guangzhou Henovcom Bioscience Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this First-in-Human study is to evaluate the safety , tolerability and pharmacokinetics after single ascending of HNC042 given to healthy subjects, compared to placebo. Also, the safety , tolerability and pharmacokinetics of multiple ascending of HNC042 given to healthy subjects daily for 7 days compared to placebo , will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer, age 18-56 years
* BMI between 18-34 kg/m2,and body weight not less than 50.0kg.

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: Between screening and 7 days after the last dose
measure: Number of subjects with abnormal laboratory
timeFrame: Between screening and 7days after the last dose
measure: Number of subjects with abnormal electrocardiogram
timeFrame: Between screening and 7 days after the last dose
measure: Number of subjects with abnormal physical examination
timeFrame: Between screening and 7 days after the last dose
measure: Number of subjects with abnormal vital signs
timeFrame: Between screening and 7 days after the last dose
Secondary outcomes:
measure: The amount of HNC042 in plasma
timeFrame: Between Day 1 predose and 24 hours after the (last) dose
measure: The amount of HNC042 in urine
timeFrame: Between Day 1 predose and 24 hours after the (last) dose
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Paolo B. DePetrillo
state: Maryland
Study officials:
References:
Clinical trial NCT01318655: Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy Subjects
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of NKTR-118 Following Single and Multiple Ascending Oral Dose Administration in Healthy Young and Elderly Japanese Subjects, and an Open Randomized, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics After Single Oral Doses of NKTR-118 in Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Japan
SAD
MAD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy subjects.

Detailed description: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of NKTR-118 following single and multiple ascending oral dose administration in healthy young and elderly Japanese subjects, and an Open Randomized, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics after single oral doses of NKTR-118 in healthy male Japanese subjects

Eligibility criteria: Inclusion Criteria:

* 20 Years to 45 Years, 65 Years to 80 Years
* Body mass index (BMI): 18 to 27 kg/m
* Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
* Non-smokers or ex-smokers (not smoked in the past 3 months).

Exclusion Criteria:

* Clinically relevant disease and/or abnormalities (past or present)
* Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis as judged by the investigator
* Use of any prescribed or non-prescribed medication including herbal remedies, vitamins and minerals during the two weeks prior to the first administration of investigational product

Primary outcomes:
measure: Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events
Secondary outcomes:
measure: Assessment of drug concentrations in plasma by characterizing PK parameters (AUC)
measure: Assessment of drug concentrations in plasma by characterizing PK parameters (Cmax)
Other outcomes:
Locations:
city: "Chuo-ku"
country: Japan
facility: Research Site
state: "Fukuoka"
Study officials:
affiliation: AstraZeneca
name: Mark Sostek, MD
role: STUDY_DIRECTOR
affiliation: Kyusyu Clinical Phramacology Research Clinic
name: Shunji Matsuki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Yukiya Sasaki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01574755: Long Term Outcome of Argon Plasma Coagulation of Cervical Heterotopic Gastric Mucosa as an Alternative Treatment for Globus Sensations
Official title: Long Term Outcome of Argon Plasma Coagulation of Cervical Heterotopic Gastric Mucosa as an Alternative Treatment for Globus Sensations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Globus Sensations in the Throat
Keywords: gastric inlet patches
argon plasma coagulation
globus sensations
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient clinic of a university hospital

Brief summary: APC of gastric inlet patches is successful for the treatment of globus sensations in the throat (Bajbouj et al Gastroenterology 2009; 137:440-4). There is no data for long term efficiency of this treatment. To measure long term efficacy all patients treated with this therapy in our clinic were followed up with complaint-evaluation sheets and endoscopy.


Eligibility criteria: Inclusion Criteria:

* former APC therapy of gastric inlet patches as treatment for globus sensations
* at least 6 month since last APC therapy

Exclusion Criteria:

* patients with reduced general condition
* malignancy of the upper gastrointestinal tract
* patients older than 80 years

Primary outcomes:
measure: Change of globus complaint score
timeFrame: retrospectively assessed: before APC therapy and at the date of follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany
name: Peter Klare, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department for Internal Medicine and Gastroenterology, Technical University Munich, Germany
name: Alexander Meining, Professor
role: STUDY_CHAIR
affiliation: Department for Internal Medicine and Gastroenterology, Technical University Munich, Germany
name: Monther Bajbouj, Assistent Professor
role: STUDY_DIRECTOR
References: