louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01536028: Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes
Official title: A Double-blind, Randomised, Four-Period Crossover Trial Comparing the Pharmacodynamics and Pharmacokinetics After Single Dose of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Insulin Aspart in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Serum C-peptide maximum 0.4 ng/mL
* Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine
* BMI (Body Mass Index) maximum 32 kg/m\^2
* HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
* Non-smoker

Exclusion Criteria:

* The receipt of any investigational drug within the last 30 days prior to this trial
* Total daily insulin dose at least 1.8 U/kg/day
* Current treatment with IAsp (insulin aspart) products
* A history of drug or alcohol abuse within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Cardiac problems
* Severe, uncontrolled hypertension

Primary outcomes:
measure: Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing
Secondary outcomes:
measure: Maximum GIR value
measure: Time to maximum GIR value
measure: Area under the GIR-curves
measure: Maximum drug concentration for insulin aspart (IAsp)
measure: Time to maximum IAsp concentration
measure: Area under the curve of the IAsp profiles
measure: Minimum drug concentration in NEFA (Nonesterified fatty acids)
measure: Time to minimum plasma concentration, NEFA
measure: Area under the curve of the NEFA profiles
measure: Adverse events
measure: Hypoglycaemic episodes
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther. 2008 Dec;10(6):479-85. doi: 10.1089/dia.2008.0019.
Clinical trial NCT03365128: Enhancing Operability in a Hypobaric Hypoxic Environment With a Small Oxygen Storage System
Official title: Enhancing Operability in a Hypobaric Hypoxic Environment With a Small Oxygen Storage System
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypobaric Hypoxemia
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal volunteers aged 18 to 65 years, inclusive

Brief summary: This is a study to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxia.

Detailed description: The purpose of this study is to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxic events. To do so, the invesitgators propose the following aims:

1. Determine the ability of a portable oxygen storage device to reverse hypobaric hypoxemia in volunteers at altitude.
2. Determine the duration of time that a single portable oxygen container can maintain normoxia in normal volunteers at altitude.
3. Determine the optimum dose and timing of oxygen use to reverse hypobaric hypoxemia.

Eligibility criteria: Inclusion Criteria:

* Altitude chamber qualified
* Previous agreement to be approached regarding altitude chamber research

Exclusion Criteria:

-

Primary outcomes:
measure: Elapsed time during which oxygen saturation by pulse oximetry (SpO2) remains above 90% I
timeFrame: 15 minutes
Secondary outcomes:
measure: Amount of oxygen needed to return SpO2 to sea level value I
timeFrame: 15 minutes
measure: Amount of oxygen needed to return SpO2 to sea level value II
timeFrame: 15 minutes
measure: Elapsed time during which SpO2 remains above 90% II
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01997528: Gas Transfer on ILA-Activve
Official title: Efficiency of Gas Exchange Using a Miniaturized Pump Driven Veno-venous Extracorporeal Gas Exchange Device (ILA-Activve)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercapnia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Oxygenatuion and decarboxylation during different settings (steps of blood flow and sweep gas flow) of extracorporeal gas exchange by ILA Activve using a jugular 22French double lumen cannula are measured.


Eligibility criteria: Inclusion Criteria:

* Patient on ILA Activve
* Controlled mechanical ventilation
* No spontaneous breathing

Exclusion Criteria:

- Pregnancy

Primary outcomes:
measure: Blood gas analysis
timeFrame: Changes after every 15 min. of each setting (13 settings leading to 195 min. altogether)
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept. of Medicine I, ICU, General Hospital of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Thomas Staudinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02078128: To Study the Effect of β-glucans on Wound Healing
Official title: To Study the Effect of β-glucans on Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: burn, wound healing, skin graft
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the effect of β-glucans on wound healing.

Detailed description: The structure of βeta-glucan (β-glucans) is a pathogen associated molecular patterns (pathogen-associated molecular patterns, PAMPs), widely present in the cell walls of plants, bacteria, yeasts, fungi, mushrooms and algae. Modern has been reported in the literature that β-glucan can enhance the immune system of animals, and to enhance the function of the animal against bacterial, fungal and viral infections, and cancer.In this study, the use of β-glucan to enhance the biological characteristics of the non-specific immunity, to explore the impact of postoperative patients with wound healing and infection rates.The observation of the healing process to take the Leather District wounds (5 \~ 200 cm2). The experiments were carried out for 18 months, were observed record the following three: (1) the rate of wound healing, (2) The rate of infection assessment: record length of time and the point in time at all levels of antibiotic use also observe the wound change (redness, swelling, heat, pain).(3) days of hospitalization, and spend statistics. Using unpaired student's t-test analysis, group data whether the differences between groups of experimental data. represents a statistically significant when p \<0.05.

Eligibility criteria: Inclusion Criteria:

1. Total burn area under 20%, two to three degree burn and need skin-grafting.
2. Subjects don't have other diseases.
3. Subjects' age between 20 to 60.

Exclusion Criteria:

1. Subjects with hypersensitivity.
2. Subjects with Autoimmune disease.

Primary outcomes:
measure: Wound healing percentage
timeFrame: every Monday and Thuresday for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Eng Kean Yeong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02309528: Chronic Kidney Disease Knowledge and Awareness Among American Indians
Official title: Chronic Kidney Disease Knowledge and Awareness Among American Indians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-12-05
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Few educational intervention clinical trials have been conducted among those at risk for or with early chronic kidney disease. To the investigators' knowledge none have used digital storytelling as a means to deliver the educational message and have been conducted among American Indians, a group with high prevalence of chronic kidney disease and end stage kidney disease.

The aims of the research project are to:

1. Quantify levels of chronic kidney disease knowledge and awareness among American Indians.
2. Determine the effectiveness of a culturally tailored health presentation with computerized digital stories made by American Indians for improving chronic kidney disease knowledge and factors thought to be preventative of chronic kidney disease or its progression at baseline and follow-up in a pilot educational clinical intervention trial.


Eligibility criteria: Inclusion Criteria:

* Strong Heart Study or Strong Heart Family Study participant

Exclusion Criteria:

* End Stage Renal Disease

Primary outcomes:
measure: Chronic Kidney Disease Knowledge
timeFrame: up to 12 months
Secondary outcomes:
measure: Blood Pressure
timeFrame: Sept 2014-Sept 2015, baseline, 1-month, 6-month, and 12-month follow-up
measure: Self-reported doctor visits and hospitalizations
timeFrame: 1-month, 6-month, and 12-month follow-up
measure: Self-reported new medical conditions
timeFrame: 1-month, 6-month, and 12-month follow-up
measure: Self-reported medication use and adherence
timeFrame: 1-month, 6-month, and 12-month follow-up
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT03970928: Goal-directed Fluid Management Versus Conventional Fluid Management in Laparoscopic Hysterectomy
Official title: Comparison of Conventional Fluid Management With Pleth Variability Index Based Goal-directed Fluid Management in Elective Laparoscopic Hysterectomies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fluid management is critical in patients undergoing surgery. Goal-directed fluid management (GDFM) protocols have been shown to decrease the length of hospital stay. In this study, we aimed to compare the effects of conventional fluid management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay.

Detailed description: Fluid management is critical in patients undergoing surgery. Goal-directed fluid management (GDFM) protocols have been shown to decrease the length of hospital stay in various kinds of surgical procedures. In this study, we aimed to compare the effects of conventional fluid management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay. Patients will be randomized to one of the study arms: group1 (conventional fluid management arm) will receive 0.9 % NaCl at a rate of 4- 8 mL/kg/h, a 250-ml bolus crystalloid/ colloid injection will be administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg.; group 2 (GDFM); group 2 (GDFM group) will receive 0.9 % NaCl at rate of 2 mL/kg/h, a 250-mL bolus crystalloid/colloid injection will be administered when PVI is higher than 13 % over 5 min. In both groups, when MAP is still \< 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus ephedrine will be administered. The groups will be compared concerning postoperative blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay.

Eligibility criteria: Inclusion Criteria:

* Must be scheduled for laparoscopic hysterectomy Must be American Society of Anesthesiologists (ASA) class I-II-III

Exclusion Criteria:

- American Society of Anesthesiologists (ASA) class IV BMI \> 40 kg/m2 Non-sinus heart rhythm MAP \<65 mmHg at the onset of anesthesia induction Advanced renal and hepatic impairment Ejection fraction \< 50 % Massive bleeding in the perioperative period

Primary outcomes:
measure: creatinine (mg/dl)
timeFrame: 3 hours after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Please Enter The State Or Province
Study officials:
affiliation: Kanuni Sultan Suleyman Hospital
name: Gulseren Yilmaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01745328: Treatment of Recurrent Urinary Tract Infection (RUTI) by Traditional Chinese Medicine
Official title: Study on Treatment of Recurrent Urinary Tract Infection by Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Urinary Tract Infection
Keywords: recurrent urinary tract infection
antibiotics
traditional chinese medicine
Lead sponsor: Beijing Institute of Disease Control and Prevention
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traditional Chinese Medicine (TCM) could be used to treat Recurrent urinary tract infection (RUTI).

Detailed description: Antibiotics and TCM are used to treat RUTI to evaluate treatment efficiencies.

Eligibility criteria: Inclusion Criteria:

* uncomplicated RUTI

Exclusion Criteria:

* complicated RUTI
* other disease with urinary tract
* infection by pathogens other than bacteria

Primary outcomes:
measure: Recovery of recurrent urinary tract infection
timeFrame: 4 weeks after study drug start
Secondary outcomes:
measure: Urinary albumin
timeFrame: 4 weeks after drug start
measure: WBC conversion
timeFrame: 4 weeks after drug start
measure: Urination frequency
timeFrame: 4 weeks after drug start
measure: Recurrence
timeFrame: 6 months after drug start
measure: urgency
timeFrame: 4 weeks after drug start
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wangjing Hospital
state: Beijing
Study officials:
affiliation: Insititute of Disease Control and Prevention
name: Zeliang Chen, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu SW, Guo J, Wu WK, Chen ZL, Zhang N. Treatment of Uncomplicated Recurrent Urinary Tract Infection with Chinese Medicine Formula: A Randomized Controlled Trial. Chin J Integr Med. 2019 Jan;25(1):16-22. doi: 10.1007/s11655-017-2960-4. Epub 2017 Jul 25.
Clinical trial NCT00044928: Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection
Official title: Randomized, Open-label, Comparative Study of Zosyn (Pip/Tazo [12g/1.5g]) Administered by Daily 24hr Continuous Infusion vs Zosyn (Pip/Tazo) [3g/0.375g]) q6h for the Treatment of Hospitalized Patients With Complicated Intra-abdominal Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Infections
Keywords: Abdominal Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-09-10
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: A Phase IV, multicenter study of hospitalized patients with complicated intra-abdominal infection.


Eligibility criteria: Inclusion Criteria

* Written informed consent will be obtained prior to enrollment into the study. If any patient is unable to give consent, it may be obtained from next of-kin or a legal representative if in accordance with local laws and regulations
* Hospitalized, ≥18 years of age
* Male or non-pregnant, non-lactating female who is post-menopausal, surgically sterilized or is using birth control pills, contraceptive implant or injection (ex: NORPLANT®; DEPO-PROVERA®), intra-uterine device, barrier methods with spermicide, or abstinence. (Effective contraception should have been in place for at least two months prior to study entry and must continue for at least 30 days after treatment discontinuation)

Exclusion Criteria

* Patients with underlying immunodeficiency disease or patients requiring chronic treatment with known immunosuppressant medications including \>5mg/day prednisone
* Active or treated leukemia, or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or antineoplastic therapy within the past year or which is anticipated to begin prior to the Test-of-Cure visit; or any known or suspected malignancy to the abdomen
* Concurrent hemodialysis, peritoneal dialysis or patients with indwelling peritoneal catheters or shunts, plasmapheresis or hemoperfusion

Primary outcomes:
Secondary outcomes:
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 NCT01495728: Thoracic Manipulation in Patients With Cervical Radiculopathy
Official title: Immediate and Short Term Effects of Thoracic Manipulation in Patients With Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Cervical Radiculopathy
Neck Pain
Manipulation
Lead sponsor: Spine and Sport, Georgia
Sponsor class: OTHER
Collaborators: name: Virginia Commonwealth University
First posted: 2011-12-20
Enrollment: 50
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: Hypothesis: The group of Cervical Radiculopathy patients receiving thoracic thrust manipulation will demonstrate immediate and short term significant clinically important changes in outcomes when compared to the sham manipulation group.


Eligibility criteria: Inclusion Criteria:

* 18-65 yrs
* 3 out 4 Items positive of Clinical Prediction Rule for Cervical Radiculopathy

Exclusion Criteria:

* history of previous cervical or thoracic spine surgery
* bilateral upper-extremity symptoms, signs or symptoms of upper motor neuron disease,
* medical "red flags" (e.g., tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use).

Primary outcomes:
measure: Global Rating of Change
timeFrame: Pre Treat, Immed, 48-72 hours
measure: Numeric Pain Rating Scale (Neck & Upper Extremity)
timeFrame: Pre Treat, Immed, 48-72 hrs
Secondary outcomes:
measure: Neck Disability Index
timeFrame: Pre Treat, Initial, 48-72 hours.
measure: Cervical Range of Motion
timeFrame: Pre-treat, immediate post, 48-72 hours
measure: Deep Neck Flexor Endurance
timeFrame: Pre Treat, Immed, 48-72 hours
measure: Numbness and Tingling Scale
timeFrame: Pre Treat, Immed, 48-72 hours
Other outcomes:
Locations:
city: Savannah
country: United States
facility: Spine and Sport
state: Georgia
Study officials:
affiliation: Spine and Sport
name: Ian A Young, PT, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02877628: Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation
Official title: Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Keywords: pharmacokinetic
pharmacodynamic
tacrolimus
CYP3A5
liver transplantation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with liver tranplantation

Brief summary: Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to clinicians or patients during the study.


Eligibility criteria: Inclusion Criteria:

* Adults over 18
* Liver transplant recipients
* Treated with an immunosuppressive protocol with tacrolimus
* Informed on the study and who did not refuse to participate

Exclusion Criteria:

* Patients who participate in a study with procedures incompatible with the present study.
* Patients with legal protection/deprived of liberty.

Primary outcomes:
measure: Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
timeFrame: Week 24
measure: Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
timeFrame: Week 24
measure: Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
timeFrame: Week 24
measure: Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
timeFrame: Week 24
Secondary outcomes:
measure: Study of impact of pharmacogenetic and demographic data on tacrolimus intracellular concentration
timeFrame: Week 24
measure: Evaluation of the role of the measurement of intracellular concentration as a longitudinal biomarker in preventing acute cellular graft (ACR)
timeFrame: Week 24
measure: Study of variability of tacrolimus intracellular concentration according to its pharmaceutic form (immediate or sustained release)
timeFrame: Week 24
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References: