louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02456688: Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency
Official title: An Open-label, Single-dose Study to Assess the Pharmacokinetics of Imrecoxib in Subjects With Impaired Hepatic Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Knee Osteoarthritis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in patients with impaired hepatic function as compared to healthy volunteers.


Eligibility criteria: Inclusion Criteria:

All subjects:

* Between the ages of 18 to 70 years, with BMI 18\~ 29kg/m2.
* In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory test values(except for values related to hepatic insufficiency).

Hepatic impaired subjects:

* Hepatocirrhosis subjects verified by B-mode ultrasonography,CT ,MRI or Biopsy.
* A Child-Pugh Classification score clinically determined as Class B.

Exclusion Criteria:

All subjects:

* History of hypersensitivity to Imrecoxib or its components.

Subjects diagnosed with tumor.

* History of or current clinically important systemic illnesses, including but not limited to cardiovascular, pulmonary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological, or psychiatric diseases.
* Have used any drugs or substances (including herbal supplements) known to inhibit or induce cytochrome P450 enzymes including cytochrome P450 3A4, cytochrome P450 2C8 and cytochrome P450 2C9 within 28 days prior to the first dose and throughout the study.
* Have taken other investigational drugs or participated in any clinical trial within 90 days prior to first dose of study drug in this study.

Hepatic impaired subjects:

* Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.

Primary outcomes:
measure: Area under the concentration time curve from 0 to infinity (AUC0-∞) after a single
timeFrame: First 5 days
measure: Maximum observed plasma drug concentration (Cmax) after a single oral dose of
timeFrame: First 5 days
measure: Time to maximum observed plasma drug concentration (Tmax) after a single oral dose of Imrecoxib.
timeFrame: First 5 days
Secondary outcomes:
measure: Apparent terminal half-life (t½) after a single oral dose of Imrecoxib.
timeFrame: First 5 days
measure: Apparent clearance (CL/F) after a single oral dose of Imrecoxib.
timeFrame: First 5 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The frist affiliated hospital of Fourth Military Medical University
state: Shanxi
Study officials:
References:
Clinical trial NCT06840288: Bronchoscopic Lung Ablation of Small Thoracic Tumors: the Blastt Registry
Official title: Bronchoscopic Lung Ablation of Small Thoracic Tumors: the Blastt Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thoracic Tumors
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: To aggregate, integrate, and analyze data facilitating the study of MD Anderson patients with a known diagnosis of lung cancer or metastases to the lungs who undergo robotic assisted bronchoscopic ablation of peripheral tumors.

Detailed description: A. To aggregate, integrate, and analyze data facilitating the study of MD Anderson participants with a known diagnosis of lung cancer or metastases to the lungs who undergo robotic assisted bronchoscopic ablation of peripheral tumors.

B. To assess the intra-operative, peri-operative, and long-term safety outcomes of robotic assisted bronchoscopic ablation of peripheral lung tumors.

C. To evaluate different oncologic outcomes including local tumor progression (LTP) by RECIST criteria, local tumor progression free survival (LTPFS), progression free-survival (PFS), disease (cancer) specific survival (DSS), and overall survival (OS).

D. To provide a deeper understanding of the evolution of radiographic findings of bronchoscopically ablated lung tumors over time.

E. To evaluate tumor and participant-related risk factors that may be associated with safety (bleeding, pneumothorax, and local infection) and oncologic outcomes (LTPFS, PFS, DSS, and OS).

Eligibility criteria: Inclusion Criteria:

* MD Anderson participants (defined as those with an MD Anderson Medical Record Number) with peripheral lung tumors (primary or metastatic) that have been or will be ablated via robotic bronchoscopy.

Exclusion Criteria:

* Patient with planned bronchoscopic ablations of peripheral lung tumors that were aborted for technical reasons (ablation was not completed).

Primary outcomes:
measure: To aggregate, integrate, and analyze data facilitating the study of MD Anderson patients with a known diagnosis of lung cancer or metastases to the lungs who undergo robotic assisted bronchoscopic ablation of peripheral tumors.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Prinicipal Investigator
name: Roberto F Casal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01476488: Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients
Official title: Conversion of Twice-a-day Tacrolimus to Once-Daily Tacrolimus Extended-Release Formulation in Stable Pediatric Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Kidney Transplantation
Pediatric Patients
Maintenance With Tacrolimus
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-11-22
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients.

Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. The patients will have another pharmacokinetic study of tacrolimus after conversion to advagraf.


Eligibility criteria: Inclusion Criteria:

* ABO-compatible kidney-only transplantation
* more than 1 year after kidney transplantation
* 5 to 15 years old
* patients maintained on Prograf
* tacrolimus level of determined previously: 4 to 20 ng/ml
* eGFR by Schwartz equation \> 50mL/min

Exclusion Criteria:

* patients with acute rejection within 90 days
* patients with acute rejection requiring antibody therapy within 6 months
* patients with more than 2 times of acute rejection within 1 year
* AST/ALT 2 times more than upper normal limit
* ABO-incompatible or crossmatch-positive transplantation
* multiorgan transplantation

Primary outcomes:
measure: Area Under the Curve of tacrolimus pharmacokinetics (AUC0-24)
Secondary outcomes:
measure: Number of Participants with Adverse Event
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Jongwon Ha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00540488: Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas
Official title: Randomized, Double Blind, Three Way Crossover Comparison of Glucose and Insulin Responses During a Meal Glucose Tolerance Test in Subjects With Type 2 Diabetes Consuming Disease-Specific Versus Standard Nutritional Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.


Eligibility criteria: Inclusion Criteria:

* signed and dated informed consent
* 18-75 years of age
* history of type 2 diabetes
* males and non-pregnant, non-lactating females

Exclusion Criteria:

* subject uses insulin for glucose control
* significant cardiovascular event \<12 weeks prior to study entry
* active malignancies
* history of end stage renal disease
* history of organ transplant
* current hepatic disease
* intervention for HIB
* takes niacin
* history of gastroparesis
* active disease that may interfere with nutrient intake
* allergy or intolerance to ingredients in the study products

Primary outcomes:
measure: Adjusted area under the curve (adj-AUC) of glucose response
timeFrame: 0-240 minutes
Secondary outcomes:
measure: Adjusted peak for glucose and insulin response;peak time for glucose and insulin response; Adj-AUC for insulin response; change in glucose and insulin; subjective gastrointestinal tolerance
timeFrame: 0 - 240 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Protocare Trials, Chicago Center for Clinical Research
state: Illinois
city: Charleston
country: United States
facility: Medical University of South Carolina
state: North Carolina
Study officials:
affiliation: Abbott Nutrition
name: Carolyn Alish, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01419288: Treadmill Training With Lower Extremity Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Traumatic Amputation of Lower Extremity
Keywords: Amputees
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2011-08-18
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people with a leg amputation have difficulty walking even after they have finished their rehabilitation. The purpose of this study is to see if a large amount of walking practice on a treadmill can improve functional abilities.


Eligibility criteria: Inclusion Criteria:

* Leg amputation that is either below the knee, through the knee, or above the knee
* Ability to walk with prosthetic
* Comfortably fitted with a prosthesis for at least 6 months
* Not currently receiving physical therapy for gait training
* Able to tolerate a moderate intensity exercise program

Exclusion Criteria:

* People with severe cardiac or pulmonary disease that limits ability to exercise.
* People with too much discomfort and/or pain that restricts their ability to walk.
* People with active wounds on their residual limb or contralateral foot.
* People who weigh more than 360lbs or are taller than 6'11" as the unweighing system can not support any greater load or height.

Primary outcomes:
measure: Change from Baseline in 6-minute walk test
timeFrame: Baseline, after training, 1 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
Study officials:
affiliation: Stony Brook University
name: Eric Lamberg, EdD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00008788: Osteoporosis in Children and Adults Following Liver Transplantation
Official title: Osteoporosis in Children and Adults Following Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Liver Transplantation
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2001-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: CROSS_SECTIONAL

Brief summary: This pilot project aims to 1) estimate the prevalence of osteoporosis in adults having undergone liver transplantation in childhood, and 2) identify risk factors for osteoporosis in this group. We aim to study 40 individuals.

Detailed description: Background: Osteoporosis is defined as an absolute decrease in the amount of bone (volume and/or density). Chronic liver disease is associated with osteoporosis in both adults and children. Bone density is also decreased in the months immediately after liver transplantation, but improves to pretransplant values after 1 to 2 years. Immunosuppressive agents, most notably steroids, are a cause of osteoporosis. However, studies on adults have shown that bone densities afer transplantation continue to improve within the normal range for healthy adults. In the case of children, bone accretion is necessary for growth. Chronic liver disease and transplantation in childhood will have an adverse effect on bone metabolism and the outcome in terms of bone density after the growth period cannot be predicted on individuals transplanted as adults or other transplant groups.

Eligibility criteria: * Liver transplantation in childhood or young adulthood

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT02558088: Pharmacological Properties of Salmeterol
Official title: Pharmacological Properties of Inhaled Salmeterol in Healthy Trained Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharmacokinetics in Healthy Young Men
Keywords: salmeterol
pharmacokinetics
doping
beta2-agonists
long-acting beta2-agonists
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 11
Sex: MALE
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: The objective of the study is to help establish a urinary threshold for salmeterol on the World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in competitive sports.

Hence, there is no hypothesis as such.


Eligibility criteria: Inclusion Criteria:

* Male
* 18-45 years
* Healthy

Exclusion Criteria:

* Chronic disease
* Smoking
* Habitual use of medicine
* Allergy towards salmeterol
* Unable to exercise on a bike ergometer

Primary outcomes:
measure: Urine concentration of salmeterol
timeFrame: 0-24 hours after administration of the study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Select State
Study officials:
affiliation: Bispebjerg Hospital
name: Vibeke Backer, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02338388: Cesarean-scar Thickness and Closure Technique
Official title: Longitudinal Transvaginal Ultrasound Evaluation of Cesarean-scar Thickness in the First Two Years After Single- or Double-layer Uterotomy Closure: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Scar Remodeling
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 435
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is the surgical method in cesarean deliveries, especially the uterotomy closure technique.

Detailed description: The aim of this prospective, randomized controlled trial was to longitudinally evaluate uterine-scar remodeling via transvaginal ultrasound after single- or double-layer uterine closure six weeks and at least six months after Cesarean delivery.

The women were included at their booking visit for an elective CD or during labor before an nonemergent CD. They were randomly assigned for three different uterotomy suture techniques: The uterus was closed with a continuous single layer locked stitch or continuous single unlocked layer or double layer.

Six weeks and between six and twenty-four month after their cesarean delivery the women were examined by transvaginal ultrasound with an empty maternal bladder, in a supine decubitus position using a GE E8 system equipped with a 5-9 MHz transducer (GE Healthcare, Milwaukee, WI).

The measurement of the uterine scar thickness was performed perpendicular to the uterine wall and was defined as shortest visible distance between the decidua and the delineation of the endometrium at the level of the cesarean scar.

Eligibility criteria: Inclusion Criteria:

* Elective cesarean section
* Cesarean section during labor

Exclusion Criteria:

* Emergency cesarean section
* Declined to participate

Primary outcomes:
measure: cesarean scar-thickness
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bamberg C, Hinkson L, Dudenhausen JW, Bujak V, Kalache KD, Henrich W. Longitudinal transvaginal ultrasound evaluation of cesarean scar niche incidence and depth in the first two years after single- or double-layer uterotomy closure: a randomized controlled trial. Acta Obstet Gynecol Scand. 2017 Dec;96(12):1484-1489. doi: 10.1111/aogs.13213. Epub 2017 Sep 21.
Clinical trial NCT03655288: A Post-marketing Surveillance to Assess Safety and Efficacy of Twotopsplus.
Official title: A Post-marketing Surveillance to Assess Safety and Efficacy of Twotopsplus.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient diagnosed with hypertension.

Brief summary: Post-marketing surveillance of Twotopsplus.

Detailed description: This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

Eligibility criteria: Inclusion Criteria:

* The patient diagnosed with hypertension.
* The patient who is first prescribed and administered Twotopsplus Tab.

Exclusion Criteria:

* The patients who are overreacting to this drug or its components.
* The patients with severe renal impairment.

Primary outcomes:
measure: Incidence of adverse event after this drug administration in general medical practice.
timeFrame: 12weeks
measure: Incidence of serious adverse event after this drug administration in general medical practice
timeFrame: 12weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References:
Clinical trial NCT01729988: Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study
Official title: Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Noblewell
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study to assess the effectiveness, safety and feasibility of carotid body removal in patients with high blood pressure (hypertension) resistant to medical treatment. Patients with high blood pressure are at significant risk of medical complications including stroke and heart disease. The principle research question is whether removal of the carotid body will lead to an improvement in the blood pressure of this patient group.


Eligibility criteria: Inclusion Criteria:

* Resistant HTN criteria with either confirmed sleep disordered breathing. Definition of HTN:Office SBP ≥ 160 mmHg and daytime mean ABPM ≥ 140 mm Hg
* Definition of sleep disordered breathing: SDB defined as mild to moderate obstructive, central or mixed sleep apnea defined as 5 \< AHI \< 30 with O2 desaturation not exceeding 80% during the night.

Exclusion Criteria:

* Calculated GFR \< 30
* Carotid body located outside the defined carotid septum
* Obstructive carotid atherosclerotic disease
* Oxygen desaturation at rest below 92%
* Known structural lung disease (medical interview)
* Requirement for oxygen therapy to maintain oxygen saturation
* Patients wish to participate in mountain climbing, skin diving or free diving
* Pregnancy or anticipation of pregnancy
* Palliative care/chemotherapy
* Acute coronary syndrome or unstable angina \< 6 months prior to procedure
* Use of exogenous insulin AND history of hypoglycemic unawareness
* Stroke or transient ischaemic attack (TIA), or myocardial infarction \< 6 months prior to procedure
* Expected life expectancy less that 24months due to other disease
* Intravenous drug use
* Excessive use of alcohol or sedatives (Alcohol intake \>28 units/week)
* Obesity (BMI \> 40)
* Upper airway or facial abnormalities
* Large neck circumference (\>43.2 cm men; \>40.6 cm women)
* Febrile illness within two weeks of participation
* Unable to attend for follow up appointments at 1, 3 and 6 months post operatively.

Primary outcomes:
measure: Change of Blood Pressure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Department of Hypertension and Diabetology, Medical University of Gdansk
Study officials:
affiliation: Cibiem, Inc.
name: Paul A. Sobotka, M.D.
role: STUDY_DIRECTOR
References: