louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02389790: Extension Study of MT-1303 in Subjects With Crohn's Disease
Official title: A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of the study are:

-To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）


Eligibility criteria: Inclusion Criteria:

* The subject completed 14 week Treatment Period in the double blind MT-1303-E13 study as per Protocol.

Exclusion Criteria:

* Permanent discontinuation of study medication prior to the end of treatment Visit in MT-1303-E13

Primary outcomes:
measure: Number of Subjects with Adverse Events
timeFrame: 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: City Name
country: Czechia
facility: Investigational site
city: City Name
country: France
facility: Investigational site
city: City Nmae
country: Germany
facility: Investigational site
city: City Nmae
country: Hungary
facility: Investigational site
city: City Name
country: Israel
facility: Investigational site
city: City Name
country: Italy
facility: Investigational site
city: City Nmae
country: Japan
facility: Investigational site
city: City Name
country: Netherlands
facility: Investigational site
city: City Name
country: Poland
facility: Investigational site
city: City Name
country: Slovakia
facility: Investigational site
city: City Name
country: Ukraine
facility: Investigational site
Study officials:
References:
Clinical trial NCT03273790: A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan
Official title: Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients - Retrospective Study of Japanese Real-World Data Through Clinical Chart Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2017-09-06
Enrollment: 939
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously treated advanced/metastatic NSCLC patients treated with nivolumab in Japan.

Brief summary: A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan


Eligibility criteria: Inclusion Criteria:

* Previously treated advanced/metastatic NSCLC patients treated with nivolumab at least once from 01-Apr-2016 through 31-Dec-2016

Exclusion Criteria:

Patients who meets the inclusion criteria will be included in the analysis to describe real-world clinical usage of nivolumab. However, patients treated with nivolumab falling in following criteria will be excluded for analysis for the other primary endpoint; overall effectiveness:

* History of participation in any clinical trials prior- or post-nivolumab treatment
* Patients who are a part of a Post-marketing surveillance study

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Description of clinical usage of nivolumab in previously treated NSCLC patients
timeFrame: Approximately 9 months
measure: Overall Survival (OS)
timeFrame: Approximately 9 months
measure: Progression Free Survival (PFS)
timeFrame: Approximately 9 months
Secondary outcomes:
measure: Percentage of patients receiving bi-weekly nivolumab
timeFrame: Approximately 9 months
measure: Percentage of patients receiving monotherapy or combination therapy
timeFrame: Approximately 9 months
measure: Percentage of patients receiving nivolumab as second or later line of therapy
timeFrame: Approximately 9 months
measure: Median treatment duration and range by line and histology
timeFrame: Approximately 9 months
measure: Rate of permanent and temporary discontinuations
timeFrame: Approximately 9 months
measure: Reasons for discontinuation of nivolumab
timeFrame: Approximately 9 months
measure: Reasons for re-challenge of nivolumab
timeFrame: Approximately 9 months
measure: Objective Response Rate (ORR) as assessed by investigator
timeFrame: Approximately 9 months
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02019290: A Study Exmining the Effect of Multiple Doses of Bitopertin on the Single Dose Pharmacokinetics of Midazolam in Healthy Volunteers.
Official title: A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE BITOPERTIN ON SINGLE DOSE PHARMACOKINETICS OF MIDAZOLAM IN HEALTHY VOLUNTEERS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy volunteers.

A single oral dose on Midazolam (7.5 mg) will be administered on Day 1 after an overnight fast. Daily oral doses of bitopertin will be given under fed conditions from Days 2-13 and after fasting on Day 14. Oral doses of bitopertin and Midazolam (7.5 mg) will be co-administered on Day 15, after an overnight fast.

Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15 days.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers, 18 to 65 years of age, inclusive.
* A BMI between 18 to 30 kg/m2, inclusive.
* Healthy as determined by the Investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs and 12-lead electrocardiogram (ECG)
* Female participants must use effective contraception as defined by the protocol and cannot be pregnant or breastfeeding
* Non-smoker or smoker of fewer than 10 cigarettes per day
* Must be able to refrain from smoking during the in-patient stay

Exclusion Criteria:

* Personal or family history of congenital long QT syndrome or family history of sudden death
* Any major illness within the 4 weeks prior to dosing or any acute disease state within 7 days prior to study start
* History of alcoholism, drug abuse or addiction within the last year prior to study start, or suspicion of drug abuse/addiction or alcohol use prior to study start
* Current alcohol consumption averaging more than 24 g of alcohol per day
* Any significant allergic reactions against any drug, or multiple allergies in the judgment of the Investigator

Primary outcomes:
measure: Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration
timeFrame: Days 1 and 15
Secondary outcomes:
measure: Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration
timeFrame: Days 1 and 15
measure: Incidence of adverse events
timeFrame: Approximately 76 days
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05605990: Clinical Application and Validation of Innovative Tourniquet
Official title: Clinical Application and Validation of Innovative Tourniquet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compartment Syndrome of Forearm
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We will recruit 160 nurses in high-risk units of the hospital.
Primary purpose: PREVENTION

Brief summary: Background: Tourniquets are the basic equipment for nurses to perform blood draws, and venous indwelling needles for congestion, or for hemostasis. Therefore, forgetting to remove the tourniquet is a common problem that leads to blood circulation being blocked, and even severe tissue necrosis occurred.

Purpose: The study aimed to evaluate whether this innovative tourniquet could prevent forgetting to remove the tourniquet, and improve the satisfaction of care.

Research design: This clinical research trial was a quasi-experimental study designed for a single group with pre-and post-test. We will recruit 160 nurses in high-risk units of the hospital. The delay in removing the tourniquet as our study outcome is defined as the removing time delay of one minute.

Expected results: The research results will provide some evidence of the efficacy of intelligent tourniquets.


Eligibility criteria: Inclusion Criteria: Nurse group: We included nurses who have working experience of more than 3 months, and are willing to use an innovative tourniquet.

Primary outcomes:
measure: Preventing the forgetting to remove the tourniquet
timeFrame: A three months period
measure: Enhancing nurses' satisfaction
timeFrame: A three months period
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Study officials:
References:
citation: Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.
citation: Lee C, Porter KM, Hodgetts TJ. Tourniquet use in the civilian prehospital setting. Emerg Med J. 2007 Aug;24(8):584-7. doi: 10.1136/emj.2007.046359.
citation: Pinkerton C. New technology enhances expertise of vascular access team. Can Nurse. 2009 Feb;105(2):21-2. No abstract available.
citation: Duignan KM, Lamb LC, DiFiori MM, Quinlavin J, Feeney JM. Tourniquet use in the prehospital setting: Are they being used appropriately? Am J Disaster Med. 2018;13(1):37-43. doi: 10.5055/ajdm.2018.0286.
Clinical trial NCT00584090: Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Urinary Incontinence
Parkinson's Disease
Keywords: urinary incontinence
parkinson's disease
vesicare
solifenacin succinate
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to measure the efficacy of solifenacin succinate (VESIcare) on treating urinary incontinence in Parkinson's disease patients.

The secondary objective of this study is to examine the effect of solifenacin succinate (VESIcare) on symptoms of PD and the patient's quality of life.


Eligibility criteria: Inclusion Criteria:

1. Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
2. Age 30 years to 80 years.
3. Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
4. Patients must score 18 or higher on the UPDRS scale and 1.0 to 2.5 on the Modified Hoehn and Yahr scale.
5. Women of child-bearing potential must use a reliable method of contraception.
6. Must be experiencing symptoms of urinary incontinence (voiding 8 or more times/day or episodes of incontinence 5 or more times per week).
7. Patients must have evidence of normal PSA and urodynamic tests within the last 12 months.
8. Clearance from the patient's urologist or internist who has examined the patient within the last 12-months.

Exclusion Criteria:

1. Any illness that in the investigator's opinion preclude participation in this study.
2. Pregnancy or lactation.
3. Concurrent participation in another clinical study.
4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
5. Legal incapacity or limited legal capacity.
6. Presence of severe renal disease (BUN 50% greater than normal).
7. Presence of major hepatic impairment.
8. Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor.
9. Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
10. History of controlled narrow angle glaucoma.

Primary outcomes:
measure: The primary purpose of this study is to measure the efficacy of solifenacin succinate (VESIcare) on treating urinary incontinence in Parkinson's disease patients.
timeFrame: 1 month
Secondary outcomes:
measure: The secondary objective of this study is to examine the effect of solifenacin succinate (VESIcare) on symptoms of PD and the patient's quality of life.
timeFrame: 1 month
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Theresa A Zesiewicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01560390: Use of Ketamine Associate With an Opioid for Sedation in ICU
Official title: Use of Ketamine Associate With an Opioid for Sedation in ICU : a Randomized Controlled Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation for Mechanical Ventilation
Keywords: Sedation
ICU
Ketamine
Confusion
Hyperalgesia
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 164
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 aim of the study is to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.

Detailed description: All consecutive mechanically ventilated patients admitted in the intensive care unit (ICU)will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.

Eligibility criteria: Inclusion Criteria:

* all patients under mechanical ventilation

Exclusion Criteria:

* pregnant
* psychotic
* chronic use of opiates
* age \< 18 years

Primary outcomes:
measure: Amount of opiate used between study enrollment and mechanical ventilation withdrawal.
timeFrame: after 24 hours
Secondary outcomes:
measure: Confusion Duration assessed by CAM-ICU
timeFrame: after 24 hours
measure: mechanical ventilation duration
timeFrame: after 24 hours
measure: ICU length of stay
timeFrame: after 24 hours
measure: Mortality at D28
timeFrame: at day 28
measure: hyperalgesia during sedation
timeFrame: after 24 hours
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Michel CONSTANTIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00893490: Ahmed Glaucoma Valve Alone, With Amniotic Membrane or With Mitomycin C (MMC) for Treatment of Refractory Glaucoma
Official title: Ahmed Glaucoma Valve Alone,With Amniotic Membrane or With MMC for Treatment of Refractory Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Refractory Glaucoma
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-05-06
Sex: ALL
Minimum age (years): 7
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This randomized, controlled trial (RCT) compares the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation alone, with 3 minutes MMC application or with a single layer coverage of amniotic membrane. Outcomes include intraocular eye pressure (IOP), postoperative glaucoma medication and complications. AGV implantation site will be superior or inferior based on indication and these groups will be randomized separately.


Eligibility criteria: Inclusion Criteria:

* patients with refractory glaucoma

Exclusion Criteria:

* children under 7 years old
* adults above 75 years old
* uncooperative patients
* patients underwent the operation for second time
* patients with major operation with AGV

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT06695390: Scale Development Study
Official title: Development of Humanistic Care Competencies Scale for Nursing Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nursing Students
Keywords: humanistic care
Nursing students
care
Lead sponsor: Bilecik Seyh Edebali Universitesi
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 340
Sex: ALL
Minimum age (years): 17
Maximum age (years): 37
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 340 stduents

Brief summary: The aim of this study was to develop a scale to measure humanistic care competencies for nursing students.

Detailed description: Studies in the literature show that humanistic care perception should develop as a student. At this point, it is of great importance to know the competency level of nursing students regarding humanistic care. Although the evaluation of competency and professional development is an important point in nursing education, the difficulty of defining the concept of competency reveals the need for measurement tools. A valid and reliable scale is needed to be used in measuring the humanistic care competencies of nursing students. Reliable measurement of humanistic care competency in nursing students will guide the education curriculum. This study is an original study in its field as it is the development of a scale measuring competency regarding humanistic care.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate.
* Being a 2nd, 3rd or 4th grade student in the nursing department.

Exclusion Criteria:

* Being a first year student.
* Being absent and on academic leave during the period in which the study was conducted.

Primary outcomes:
measure: Information questionnaire on socio-demographic characteristics of nursing students
timeFrame: 12/11/2024-20/11/2024
measure: Scale questionnaire measuring humanistic care competence of nursing students
timeFrame: 01/11/2024-01/12/2024
Secondary outcomes:
Other outcomes:
Locations:
city: Bilecik
country: Turkey
facility: Bilecik Şeyh Edebali University
Study officials:
References:
Clinical trial NCT02076503: Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status
Official title: Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Neoplasm Staging
Positron-Emission Tomography
Magnetic Resonance Imaging
1-amino-3-fluorocyclobutane-1-carboxylic acid
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Norwegian Cancer Society
First posted: 2014-03-03
Enrollment: 28
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate staging of the disease at the time point of diagnosis is important. The objective of this study is to evaluate the diagnostic potential of a combined PET/MR examination for risk assessment and detection of lymph node metastases. The overall aim of the project is to improve the investigators ability to provide individually tailored treatment to prostate cancer patients.

The study will include 32 men with high-risk prostate cancer, who are eligible for radical prostatectomy. Informed consent is a requirement for inclusion in the study.


Eligibility criteria: Inclusion Criteria:

* High-risk prostate cancer according to EAU guidelines (Gleason score ≥8 and/or PSA ≥20 ng/ml and/or ≥ cT3a cancer)
* Eligibility for the surgical procedure (radical prostatectomy and bilateral pelvic lymph node resection)

Exclusion Criteria:

* Previous treatment (for example TURP or hormone therapy)
* Contraindication for the PET/MR examination (including, but not limited to: pacemaker, aneurysm clips, reduced renal function, metal implants, claustrophobia)

Primary outcomes:
measure: Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Dept Urologic Surgery, St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Anders Angelsen, prof
role: STUDY_DIRECTOR
References:
citation: Elschot M, Selnaes KM, Sandsmark E, Kruger-Stokke B, Storkersen O, Tessem MB, Moestue SA, Bertilsson H, Bathen TF. A PET/MRI study towards finding the optimal [18F]Fluciclovine PET protocol for detection and characterisation of primary prostate cancer. Eur J Nucl Med Mol Imaging. 2017 Apr;44(4):695-703. doi: 10.1007/s00259-016-3562-7. Epub 2016 Nov 5.
citation: Selnaes KM, Kruger-Stokke B, Elschot M, Willoch F, Storkersen O, Sandsmark E, Moestue SA, Tessem MB, Halvorsen D, Kjobli E, Angelsen A, Langorgen S, Bertilsson H, Bathen TF. 18F-Fluciclovine PET/MRI for preoperative lymph node staging in high-risk prostate cancer patients. Eur Radiol. 2018 Aug;28(8):3151-3159. doi: 10.1007/s00330-017-5213-1. Epub 2018 Jan 2.