louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03381170: An Extension of the TG1101-RMS201 Trial
Official title: An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Relapsing Multiple Sclerosis
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis


Eligibility criteria: Inclusion Criteria:

* Subjects currently enrolled in TG1101-RMS201 trial
* Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit

Exclusion Criteria:

* Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period
* Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial
* Pregnant or nursing mothers

Primary outcomes:
measure: Number of participants with treatment-related events as assessed by CTCAE V4.0
timeFrame: 96 weeks on therapy
Secondary outcomes:
measure: Evaluate the % of participants with relapses
timeFrame: up to 96 Weeks
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Aurora
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Lexington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kentucky
city: Columbus
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Westerville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Knoxville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Round Rock
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: San Antonio
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
Study officials:
References:
Clinical trial NCT06330870: Brain Metastasis Development Mechanism in BCBM Patients
Official title: Evaluation of Brain Metastasis Development Mechanism in Patients With Breast Cancer With Brain Metastasis(BCBM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Brain Metastasis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis


Eligibility criteria: Inclusion Criteria:

* Breast cancer
* Brain metastasis curative surgery patient

Exclusion Criteria:

* Gamma Knife surgery patient

Primary outcomes:
measure: Intracranial disease free survival
timeFrame: Months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ji-Yeon Kim
Study officials:
References:
Clinical trial NCT06194370: The Application of BOPPPS（Bridge-in,Objective,Pre-assessment,Participatory Learning,Post-assessment,Summary） Model in the Ward Rounds of Nurses' Standardized Training
Official title: The Application of BOPPPS（Bridge-in,Objective,Pre-assessment,Participatory Learning,Post-assessment,Summary） Model in the Ward Rounds of Nurses' Standardized Training
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Standardized Training
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Nursing standardization training students in a top-three hospital in Chongqing from July 2017 to June 2022 were selected as the research objects, excluding nursing students who participated in online courses during the epidemic period. The BOPPPS(Bridge-in,Objective,Pre-assessment,Participatory learning,Post-assessment,Summary) teaching model was applied to the standardized training of nurses and compared with the conventional teaching methods to evaluate the effect of improving the theoretical knowledge, professional skills and comprehensive ability of nursing students.


Eligibility criteria: Inclusion Criteria:

* Nursing standardization training students in a top-three hospital in Chongqing

Exclusion Criteria:

* Nursing students who participated in online courses during the epidemic period

Primary outcomes:
measure: Comprehensive ability evaluation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT05159570: Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Metabolic Effects. (KETO-HFpEF-Metabolic)
Official title: Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Metabolic Effects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Diabetes Mellitus, Type 2
Ketonemia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial effects in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF).

In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on whole body and skeletal metabolism in patients with HFpEF and T2D.


Eligibility criteria: Inclusion Criteria:

(i) Type 2 diabetes, (ii) LVEF \> 40 %, (iii) a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness \> 12 mm) and/or previous myocardial infarction, (iiii) age ≥ 18 years old, and (iv) one of the following criteria (a-d) should be fulfilled:

Echocardiographic signs of diastolic dysfunction E/e' \> 8 Septal e ́\< 7 cm/s and/or lateral e ́ \< 10 cm/s Left atrium volume index ≥34 mL/m2 and/or left atrial diameter \> 4 cm NT-proBNP \> 125 pg/ml.

Exclusion Criteria:

* Insulin treatment, inability to give informed consent

Primary outcomes:
measure: Differences in lipolysis rate
timeFrame: After 14 days treatment
Secondary outcomes:
measure: Changes in glucose kinetic
timeFrame: After 14 days treatment
measure: Changes in signaling in muscle and adipose tissue
timeFrame: After 14 days treatment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT02042170: Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients
Official title: A Phase II, Multi-center, Randomized, Comparative, Parallel, Open, Dose Finding Study to Assess the Efficacy and Safety After 26 Week-treatment of Eutropin Plus (SR-hGH) Compared to Eutropin Inj. in Pre-pubertal Children With Idiopathic Short Stature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Establishing Dose of Sr-hGH in ISS Patients
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2014-01-22
Enrollment: 46
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess dosing requirements and establish the efficacy of SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as multi-center, randomized, active comparator-controlled, parallel, open-label.

45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the other arm received daily hGH at 0.37 mg/kg/week.

Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And patients randomized to daily hGH group injected for 6 days a week.

Patients visited study centers five times, firstly at screening (Visit 1), at randomization (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for follow-up (Visit5).


Eligibility criteria: Criteria

* are older than or equal to age of 4
* are pre-pubertal (Tanner's stage I)
* are younger than bone age of 9 in female; of 11 in male
* have less than 3 years of a difference in bone and chronological age
* have confirmed idiopathic short stature

Primary outcomes:
measure: Change from baseline in height velocity at Week 26, cm/year
timeFrame: Week 0-26
Secondary outcomes:
measure: Change from baseline in height velocity, cm/year
timeFrame: at Week 13
measure: Change from baseline in height, cm
timeFrame: at Week 13 and 26
measure: Change from baseline in IGF (Insulin-like growth factor)-I and IGF-I SDS (standard deviation score)
timeFrame: at Week 13 and 26
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ho Sung Kim
Study officials:
References:
Clinical trial NCT00876070: Community Oncology Setting Cost Analysis and Disease Outcomes of Taxane Use in Metastatic Breast Cancer
Official title: Community Oncology Setting Cost Analysis and Disease Outcomes of Taxane Use in Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer
Breast Cancer
MBC
Abraxane
Paclitaxel
Taxol
Docetaxel
Taxotere
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2009-04-06
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Metastatic Breast Cancer from January 2005 to three months prior to site-specific protocol initiation will be eligible. This will include current/actively being treated patients as well as patients who have previously completed therapy.

Brief summary: This is a retrospective medical record abstraction study. It is a review and evaluation of up to 300 metastatic breast cancer patients treated with Abraxane or other taxanes such as paclitaxel and docetaxel to determine the overall cost of care for Abraxane compared to other taxanes in the first-line metastatic cancer setting and the cost of care for Abraxane compared to other taxanes when broken down by individual components of cost. In addition, the investigators will review the following patient outcomes: response rate, duration of therapy, toxicity, and survival.


Eligibility criteria: Inclusion Criteria:

* Patients that have received Abraxane chemotherapy greater than three months from the time of chart review.
* Patients that have received taxane chemotherapy greater than three months from the time of chart review.

Primary outcomes:
measure: Describe patient demographics, disease and treatment characteristics.
timeFrame: 6 months
Secondary outcomes:
measure: Describe detailed treatment and response characteristics.
timeFrame: 6 months
measure: Describe resource utilization and cost variables.
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Jeffrey F Patton, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02231970: Endoscopic Sleeve Gastroplasty for Treatment of Obesity
Official title: Endoscopic Sleeve Gastroplasty for Treatment of Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Endoscopic sleeve gastroplasty
Weight loss
Lead sponsor: Grupo Hospital de Madrid
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy.

The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the treatment of patients with obesity

Detailed description: The endoscopic sleeve gastroplasty method to perform endoluminal gastric reduction were by a cap-based flexible endoscopic suturing system. Post procedure care includes close follow-up by a nutritionist and a psychologist weekly.The outcome assessment included: change in body weight, percentage of loss of excess body weight and adverse effects

Eligibility criteria: Inclusion Criteria:

Obesity Willingness and ability of patients to be treated by a multidisciplinary team for at least 1 year -

Exclusion Criteria:

Prior endoscopy discarded patients with gastric findings (potentially bleeding lesions and neoformative findings ) Coagulopathy Psychiatric disorders

-

Primary outcomes:
measure: Change in body weight
timeFrame: One year
Secondary outcomes:
measure: Safety
timeFrame: One year
Other outcomes:
measure: Percentage of excess weight loss
timeFrame: One year
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Sanchinarro
Study officials:
affiliation: HOSPITAL UNIVERSITARIO SANCHINARRO
name: GONTRAND LOPEZ-NAVA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02433470: Association of Functional Changes in the Brain and the Perception of Pain in Patients With Chronic Inflammatory Bowel Diseases (IBD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammatory Bowel Disease
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the study the investigators aim to test whether transcranial direct current stimulation (tDCS)-induced pain reduction is in association with functional changes in the brain measured with magnetic resonance imaging (MRI) in patients with chronic inflammatory bowel diseases (IBD).

Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases, which is in association with changes in the brain measured via MRI.


Eligibility criteria: Inclusion Criteria:

* Inflammatory bowel disease
* Chronic pain (more than 3 months)
* Pain (VAS \> 3/10)

Exclusion Criteria:

* Contraindication to transcranial direct current stimulation
* Contraindications to magnetic resonance imaging (MRI)
* Pregnancy
* Sever internal or psychiatric condition

Primary outcomes:
measure: Functional and/or structural changes in the brain measured with cerebral MRI
timeFrame: 1 week
measure: Changes in perception of pain measured with visual analogue scale and pain pressure threshold
timeFrame: 2 weeks
Secondary outcomes:
measure: Changes in quality of life
timeFrame: 2 weeks
measure: Changes in functional symptoms (questionnaire: Irritable bowel syndrome - severity scoring system (IBS-SSS))
timeFrame: 2 weeks
measure: Changes in activity indices (Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index)
timeFrame: 2 weeks
measure: Changes in pain catastophizing scale
timeFrame: 2 weeks
measure: Changes in inflammation bBlood)
timeFrame: 2 weeks
measure: Changes in inflammation (stool - calprotectin)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine
Study officials:
affiliation: Charite University
name: Magdalena S Prüß-Volz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00223470: Cytokine Regulation of Periradicular Pain in Humans
Official title: Cytokine Regulation of Periradicular Pain in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Apical Periodontitis of Pulpal Origin
Keywords: pain
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2005-09-22
Enrollment: 9
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the Endodontics department with an indication for root canal treatment

Brief summary: This clinical trial evaluates the role of cytokines in patients needing root canal treatment with diagnosis of necrotic pulp and chronic apical periodontitis

Detailed description: This study evaluates whether periradicular exudate concentrations of cytokines differ in patients experiencing pain and mechanical allodynia due to pulpal necrosis with an acute exacerbation of a chronic apical periodontitis, as compared to patients with pulpal necrosis with chronic apical periodontitis, but no pain or mechanical allodynia

Eligibility criteria: Inclusion Criteria:

1. Patient must be at least 16 years of age.
2. Clinical indication for Non-Surgical Root Canal Therapy (NSRCT).
3. 1st or 2nd maxillary or mandibular molar
4. Diagnosis must be Chronic Apical Periodontitis (CAP) with or without symptoms.
5. Intact, mature apices.
6. ASA I or II

Exclusion Criteria:

1. Failure to meet any of the above
2. Previous NSRCT
3. Previous pulpotomy or pulpectomy
4. Suppurative apical periodontitis
5. Patients taking medications which can affect their pain rating or medications which effect their immune system ( such as glucocorticoids)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Univerity of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Asma A Khan, BDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03187470: Left Ventricular Dyssynchrony in Multipole Pacing
Official title: The Impact of Multipole Pacing (MPP) on Left Ventricular Dyssynchrony in Patients With Cardiac Resynchronization Therapy (CRT) - a Real-Time Three Dimensional Echocardiography Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure，Congestive
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
First posted: 2017-06-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator.

Detailed description: Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator using a quadripolar left ventricular lead.

Eligibility criteria: Inclusion Criteria:

* Indication for the implantation of a defibrillator with cardiac resynchronisation therapy

Exclusion Criteria:

* Cardiac surgery, acute coronary syndrome / myocardial infarction, percutaneous coronary intervention within the past 4 weeks
* Indication for coronary artery revascularisation
* Atrial fibrillation with insufficient rate control
* ASA (American Society of Anesthesiologists) class V or cardiogenic shock
* age \<18 years, pregnancy, tutelage
* inability to understand the patient consent for or study refusal
* anticipated insufficient echocardiographic image quality

Primary outcomes:
measure: Left ventricular dyssynchrony
timeFrame: 15 minutes
Secondary outcomes:
measure: left ventricular ejection fraction
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Deutsches Herzzentrum München
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Severin Weigand, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weigand S, Karl M, Brkic A, Lennerz C, Grebmer C, Blazek P, Kornmayer M, Schaarschmidt C, Wesemann L, Reents T, Hessling G, Deisenhofer I, Kolb C. The impact of multipole pacing on left ventricular function in patients with cardiac resynchronization therapy - A real-time three-dimensional echocardiography approach. Int J Cardiol. 2018 Dec 1;272:238-243. doi: 10.1016/j.ijcard.2018.08.033. Epub 2018 Aug 15.