louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01147692: A Drug Interaction Study of Simvastatin and Albiglutide
Official title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: albiglutide
simvastatin
healthy volunteers
pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.

Detailed description: This Phase I open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.

Eligibility criteria: Inclusion Criteria:

* no clinically significant diseases or clinically significant abnormal laboratory values
* females must be of non-childbearing potential
* body mass index (BMI) is \>/=18 kg and ≤30 kg/m2
* nonsmoker
* negative drug screen

Exclusion Criteria:

* positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
* any clinically relevant abnormality
* female subject is pregnant or breast-feeding
* history of any anaphylactic reaction to any drug
* history of significant cardiovascular or pulmonary dysfunction
* current or chronic history of liver disease
* history of alcohol or substance abuse
* history of thyroid dysfunction or disease
* history of gastrointestinal surgery or disease
* history of pancreatitis
* previously received any GLP-1 mimetic compound (e.g., exenatide)

Primary outcomes:
measure: The effect of albiglutide on the pharmacokinetics of simvastatin
timeFrame: 42 days
Secondary outcomes:
measure: The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide
timeFrame: 42 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
Clinical trial NCT02036892: Electronically Connected Health Coaching in Type 2 Diabetes
Official title: Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Diabetes
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2014-01-15
Enrollment: 115
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: Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone).

Detailed description: Inclusion criteria: all participating patients have been diagnosed with Type 2 Diabetes, are between 25 and 70 years of age, have a regular primary care physician, and have HbA1c levels \> or = to 7.3.

Exclusion criteria: Axis I and II psychiatric disorders.

Primary outcome: HBA1c at 6 months follow up.

Secondary outcome: Centre for Epidemiological Studies Depression Scale

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Type 2 Diabetes
* Fluency in English and/or Spanish

Exclusion Criteria:

* \> 75 years of age

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 months follow up from baseline
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale
timeFrame: 6 months follow up from baseline assessment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Black Creek Community Health Centre
state: Ontario
Study officials:
affiliation: York University
name: Paul Ritvo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wayne N, Perez DF, Kaplan DM, Ritvo P. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial. J Med Internet Res. 2015 Oct 5;17(10):e224. doi: 10.2196/jmir.4871.
citation: Pludwinski S, Ahmad F, Wayne N, Ritvo P. Participant experiences in a smartphone-based health coaching intervention for type 2 diabetes: A qualitative inquiry. J Telemed Telecare. 2016 Apr;22(3):172-8. doi: 10.1177/1357633X15595178. Epub 2015 Jul 21.
Clinical trial NCT01394692: Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery
Official title: Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioma
Keywords: intraoperative MRI
glioma surgery
extent of resection
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2011-07-14
Enrollment: 58
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: Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition.

In order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. The intraoperative MRI devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow.

Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma surgery are lacking. To assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative MRI-guidance, we designed this prospective, randomized trial. We hypothesized that the extent of resection that can be achieved using an intraoperative MRI is greater than that of conventional microsurgical tumor resection.


Eligibility criteria: Inclusion Criteria:

* known or suspected contrast-enhancing glioma (primary and recurrent)
* location of the tumor permits intended gross-total resection

Exclusion Criteria:

* tumor location prohibits or questions gross-total resection
* contraindications to undergo MRI examinations

Primary outcomes:
measure: Extent of Resection
timeFrame: 72 hours
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 6 months
measure: Volumetric Assessment
timeFrame: 72 hours
measure: Neurological Deficit
timeFrame: 7 days
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Department of Neurosurgery, Goethe-University
Study officials:
affiliation: Goethe University
name: Christian Senft, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Goethe University
name: Volker Seifert, M.D.
role: STUDY_DIRECTOR
References:
citation: Senft C, Bink A, Franz K, Vatter H, Gasser T, Seifert V. Intraoperative MRI guidance and extent of resection in glioma surgery: a randomised, controlled trial. Lancet Oncol. 2011 Oct;12(11):997-1003. doi: 10.1016/S1470-2045(11)70196-6. Epub 2011 Aug 23.
Clinical trial NCT01823692: Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction
Official title: Study of Accuracy of Ultrasonography in Determining the Adequacy of Distal Radius Fracture Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Distal Radius Fracture
Keywords: Radius Fracture
Sensitivity
Reduction
Adequacy
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 184
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate whether ultrasonography guidance compare with the simple radiography aids in determining the adequacy of distal radius fracture reduction.

Detailed description: Distal radius fracture is one of the most common causes for visiting the emergency department. Nowadays, simple radiography is used as a control standard for evaluating reduction of distal radius fractures. The disadvantages include time wasting, frequent x-ray exposures and use of more sedation in determining adequate reduction, made scientists to evaluate alternative method such as ultrasonography which fast, easy and less dangerous were considered as advantages. The investigators goal was to identify whether ultrasonography guidance compare with the simple radiography aids in determining the adequacy of distal radius fracture reduction.

Eligibility criteria: Inclusion Criteria:

* \> 21 years old and a diagnosing of a distal radius fracture based on simple radiography.

Exclusion Criteria:

* Open fractures
* more than 20 degree angulation
* joint internal involvement, communicated and along with Neurovascular compromised fractures
* patient's surgery due to other causes
* need to stay in the ICU and not being able to be treated at the same time for distal radius fracture
* patient's refusal to participate in the study

Primary outcomes:
measure: adequacy of distal radius fracture reduction
timeFrame: at 5 min after admission time
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-Zahra University Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Hamidreza Shemshaki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05084092: IORT After Surgical Resection of Brain Metastases
Official title: IORT After Surgical Resection of Brain Metastases: Feasibility and Efficacy Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain Neoplasms
Keywords: Brain metastases
neurosurgery
intraoperative radiotherapy
local therapy
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intraoperative Radiation Therapy (IORT)
Primary purpose: TREATMENT

Brief summary: To evaluate the feasibility and efficacy of the Intraoperative Radiation Therapy (IORT) after the resection of a brain metastases to reduce the incidence of local relapse


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years, Karnofsky Performance Index ≥ 70.
* Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1- weighted MRI scan) amenable to total resection with no dural attachment.
* Frozen section confirming a metastasis of an extracranial (i.e. non-CNS) tumor.
* Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy).
* Adequate birth control.
* Informed consent.

Exclusion Criteria:

* Leptomeningeal spread and dural attachment (assessed pre- and intraoperative).
* Frozen section reveals primary CNS tumor, lymphoma, SCLC or germinoma.
* Psychiatric or social condition potentially interfering with compliance.
* Contraindication against anesthesia, surgery, MRI and/or contrast agents.
* Pregnant or breast-feeding women.

Primary outcomes:
measure: Median local progression free survival (PFS)
timeFrame: 12 months
Secondary outcomes:
measure: Median regional PFS (rPFS)
timeFrame: 12 months
measure: Global PFS (gPFS)
timeFrame: 12 months
measure: Median time to the initiation of systemic therapies
timeFrame: 12 months
measure: Median overall survival (OS)
timeFrame: 12 months
measure: Change in neurocognitive performance (compared to baseline): Minimental
timeFrame: 6, and 12 months
measure: Change in neurocognitive performance (compared to baseline): Trail making
timeFrame: 6, and 12 months
measure: Change in neurocognitive performance (compared to baseline): Repetition
timeFrame: 6, and 12 months
measure: Change in neurocognitive performance (compared to baseline): Oral
timeFrame: 6, and 12 months
measure: Change in neurocognitive performance (compared to baseline): Semantic
timeFrame: 6, and 12 months
measure: Quality of life (QoL)
timeFrame: 6, and 12 months
measure: Radiation-related (acute / early delayed / late) neurotoxicity
timeFrame: 12 months
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Catalan Institute of Oncology
state: Barcelona
Study officials:
affiliation: Institut Català d'Oncologia
name: Miquel Macià, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00820092: Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers
Official title: A Phase 1,Dose Escalation Study to Compare the Safety, Tolerability,Pharmacokinetic and Pharmacodynamic Profiles of the 24-hour Intravenous Administration of Xerecept in Healthy Japanese and Caucasian Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Edema
Keywords: Xerecept
Pharmacokinetics
Japanese versus Caucasians
Lead sponsor: Celtic Pharma Development Services
Sponsor class: INDUSTRY
First posted: 2009-01-09
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To investigate the safety and tolerability of Xerecept during and following a 24-hour intravenous administration to healthy Japanese to healthy Japanese and Caucasian subjects
2. To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept administration between healthy Japanese and Caucasian subjects

Detailed description: none needed

Eligibility criteria: Inclusion Criteria:

* Healthy male and female Japanese subjects who are citizens of Japan
* Healthy male and female Caucasian subjects
* Age range 20-45 years
* BMI \>19 and \<27 kg/m squared

Exclusion Criteria:

* Female subjects must not be pregnant at the time of study and use adequate birth control methods before,during and 4 weeks after the study
* Subjects must be negative for HCV and HIV
* Subjects must have negative urine tests for drugs of abuse and alcohol at screening
* Subjects must not have any clinically significant medical conditions

Primary outcomes:
measure: Frequency and severity of AEs Clinical laboratory tests( chemistry,hematology,urinalysis) Physical exam and vital signs ECG AUC, Tmax Cmax Terminal half life AUC for cortisol concentration
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials
state: California
Study officials:
References:
Clinical trial NCT04305392: Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment
Official title: Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment (Multicenter, Single Dose, Parallel, Open)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to evaluate pharmacokinetics, pharmacodynamics and safety of SHR4640 in patients with mild, moderate hepatic impairment and normal liver function in phase I clinical study.


Eligibility criteria: Inclusion Criteria:

-

All subjects:

* Signing the informed consent forms.
* 18 years to 65 years (inclusive).
* Body mass index should be between 18 and 30 kg/m2 (inclusive).
* No medication was used before screening#or stable medication for 4 weeks.

Normal liver function:

• Clinical laboratory tests during the screening period were normal or the abnormality has no clinical significance.

Hepatic impaired subjects:

* Child-Pugh Classification score clinically determined as mild or moderate hepatic impairment.
* Liver damage due to primary liver disease.

Exclusion Criteria:

-

All subjects:

• Subject known or suspected of being sensitive to the study drugs or its ingredient.

Normal liver function:

* Previous history of liver function impairment, or physical examination and laboratory examination at screening indicated the presence or possibility of liver function impairment.
* Hepatitis B surface antigen (HBsAg) positive or Anti-hepatitis C virus (HCV) antibody or hepatitis C core antigen positive within 3 months prior to administration.

Hepatic impaired subjects:

* Suspected or diagnosed as liver cancer or with other malignant tumors.
* Drug induced liver injury#acute liver injury#liver transplantation history.
* Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 72 hours after dosing
measure: Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞)
timeFrame: 72 hours after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Meixia Wang
state: Beijing
Study officials:
References:
Clinical trial NCT05333692: Oral Nutritional Supplementation of Hemodialysis Patients
Official title: Oral Nutritional Supplementation of Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Lead sponsor: Fresenius Kabi Taiwan Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chung Shan Medical University
First posted: 2022-04-19
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to demonstrate that increase in serum albumin concentration (week 8 -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not relevantly smaller than that after control treatment with NEPRO®.


Eligibility criteria: Inclusion Criteria:

1. Age 40-80 years
2. Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least.
3. Malnutrition patients. Definition of Malnutrition is serum albumin level\<3.5g/dL, calorie digestion below 35kcal/IBW or protein digestion below 1.2g/IBW.

Exclusion Criteria:

1. BMI\<18.5 and calorie intake unable to reach 50% of the recommended level
2. BMI\>30 kg/m2,
3. abnormal liver function,
4. malignant disease,
5. scheduled surgery within a month or after surgery,
6. infectious disease,
7. suboptimal tolerance of nutritional supplements,
8. inflammatory bowel disease, bowel obstruction,
9. acute condition complicated with multiple organ failure or under palliative care.

Primary outcomes:
measure: Serum Albumin level change
timeFrame: baseline, weerk 4 and week 8
Secondary outcomes:
measure: Body Weight (kg) and Height(cm) change, and these results will be combine to report BMI (kg/m^2) change
timeFrame: baseline, weerk 4 and week 8
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
References:
Clinical trial NCT01168492: Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
Official title: Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pediatric
gastroscopy
colonoscopy
sedation
ketamine
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether ketamine, midazolam, and meperidine are more effective than midazolam and meperidine alone for procedural sedation and analgesia in pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side effects and the necessity of rescue doses.

Detailed description: 90 patients will be included. The sedation will include 0.1mg/kg, max 5mg iv of midazolam, 1mg/kg, max 50mg iv of meperidine, and placebo (0.9%NaCl) or ketamine 0.5mg/kg iv. Rescue doses will be given as usual, using meperidine and or midazolam 50% of the initial dose.

Eligibility criteria: Inclusion Criteria:

* Children =/\> 10 years of age
* Undergoing elective diagnostic colonoscopy
* ASA score class 1-3.

Exclusion Criteria:

* Children younger than 10 years of age
* Known epilepsy under treatment
* ASA score class 4 or more
* Interventional colonoscopy (e.g.polypectomy)

Primary outcomes:
measure: pain score
timeFrame: after one year
Secondary outcomes:
measure: necessity of cardiopulmonary intervention (Oxygen requirements)
timeFrame: after one year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Sainte Justine Hospital
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Denise Herzog, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gilger MA, Spearman RS, Dietrich CL, Spearman G, Wilsey MJ Jr, Zayat MN. Safety and effectiveness of ketamine as a sedative agent for pediatric GI endoscopy. Gastrointest Endosc. 2004 May;59(6):659-63. doi: 10.1016/s0016-5107(04)00180-4.
citation: McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc. 2008 May;67(6):910-23. doi: 10.1016/j.gie.2007.12.046.