louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00171977: Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
Official title: Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST
Imatinib
Postoperative Adjuvant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.


Eligibility criteria: Inclusion Criteria:

* underwent macroscopically curative resection;
* immunohistochemically confirmed KIT (CD117)-positive tumors;
* judged as being high-risk according to the criteria for risk classification

Exclusion Criteria:

* synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years;
* received therapy with Imatinib Mesylate prior to study entry;
* cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)

Other protocol-defined inclusion / exclusion criteria may apply.

Primary outcomes:
measure: To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy
timeFrame: 3 years
Secondary outcomes:
measure: To evaluate overall survival, relapse free
timeFrame: 3 years
measure: Safety
timeFrame: 3 years
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Kanda T, Nishida T, Wada N, Kobayashi O, Yamamoto M, Sawaki A, Boku N, Koseki M, Doi T, Toh Y, Kakeji Y, Sugiyama T, Komatsu Y, Kikuchi S, Ogoshi K, Katai H, Miyachi K, Hirota S, Ohtsu A. Adjuvant therapy with imatinib mesylate after resection of primary high-risk gastrointestinal stromal tumors in Japanese patients. Int J Clin Oncol. 2013 Feb;18(1):38-45. doi: 10.1007/s10147-011-0339-7. Epub 2011 Nov 23.
citation: Essat M, Cooper K. Imatinib as adjuvant therapy for gastrointestinal stromal tumors: a systematic review. Int J Cancer. 2011 May 1;128(9):2202-14. doi: 10.1002/ijc.25827.
Clinical trial NCT01202045: Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients
Official title: Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients With Indirect Signs of Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Scleroderma, Systemic
Hypertension, Pulmonary
Keywords: Echocardiography, Stress
right heart catheterization
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Systemic slerosis patients with indirect signs of arterial pulmonary hypertension:

* Effort dyspnea (NYHA \>= 2/4)
* DLCO \< 60%
* FVC% / DLCO% \> 1.6
* SPAP \> 40 mmhg and \< 55 mmhg

Brief summary: The purpose of this study is to assess the value in terms of sensitivity, specificity and likelihood ratio of the stress echocardiography in the screening of pulmonary arterial hypertension in patients with systemic sclerosis and indirect signs of pulmonary arterial hypertension.

Detailed description: Pulmonary artery catheterization (rest and exertion) and treadmill stress echocardiography will be done to all patients of the study.

Eligibility criteria: Inclusion Criteria:

* At least one of the prespecified indirect sign of pulmonary arterial hypertension
* Able to exercise on treadmill

Exclusion Criteria:

* left ventricular dysfunction at rest
* Absence of pulmonary regurgitant flow
* Pregnancy or breastfeeding
* Smoking with \> 60 pack-year

Primary outcomes:
measure: Correlation of a 20 mmhg increase in the pulmonary artery pressures (PAP) during stress echocardiography and PAP using right heart catheterization.
timeFrame: 5 years
Secondary outcomes:
measure: Correlation of a 20 mmhg increase in the PAP during stress echocardiography and elevated NT-proBNP.
timeFrame: 5 years
measure: Function of the left ventricle (left ventricular ejection fraction) at rest and at stress.
timeFrame: Follow up every year X 5
measure: Diastolic function at rest and at stress
timeFrame: follow up every year X 5
measure: Function of the right ventricle
timeFrame: Follow up every year X 5
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Paul Farand, md, msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05492045: A Study to Evaluate D-1553 in Combination Therapy in Non-Small Cell Lung Cancer
Official title: A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combination Therapy in Subjects With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: NSCLC
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combination Therapy in Subjects with KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.


Eligibility criteria: Inclusion Criteria:

* Subject with histologically proven, locally advanced or metastatic NSCLC for which has no standard treatment or the subject has been previously treated with first- or second-line systemic therapy.
* Subject has KRasG12C mutation in tumor tissue or other biospecimens containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a local laboratory.
* Subject has measurable disease according to RECIST v1.1. For phase 1b subjects who have no measurable lesions but whose disease can be evaluated are also acceptable.

Exclusion Criteria:

* Subject with unstable or progressive central nervous system (CNS) metastases.
* Subjects with clinically significant cardiovascular disease.
* Subject with interstitial lung disease (ILD) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
* Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
* Subject is pregnant or lactating.

Primary outcomes:
measure: Subject incidence of Dose-limiting toxicities (DLT)
timeFrame: Through out the DLT period, approximately 21 days
measure: Number of subjects participants with adverse events
timeFrame: Till study completion, approximately 3 years
measure: Antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation
timeFrame: Till study completion, approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences
state: Zhejiang
Study officials:
References:
Clinical trial NCT03018145: Effect of Transportation Method on Preoperative Anxiety in Children
Official title: Effect of Transportation Method on Preoperative Anxiety in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Child Behavior
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car for reducing preoperative children's anxiety.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist physical status I
* scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* history of anesthesia or surgery
* developmental delay
* weighing over than 38kg
* severe pain
* administrated psychotomimetic drug

Primary outcomes:
measure: Preoperative anxiety score using the Modified Yale Preoperative Anxiety Scale
timeFrame: From entry of operating room to induction of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
References:
Clinical trial NCT03118245: Ambu AuraGain Laryngeal Mask Airway and I-gel in Children
Official title: A Randomized Comparison of Ambu AuraGain (Original Name of Product) Laryngeal Mask Airway and I-gel in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 94
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Children aged below 7 years are randomly assigned to AuraGain Group or I-gel group. After anesthetic induction, AuraGain or I-gel is inserted and mechanical ventilation is started. Oropharyngeal leak pressure, peak inspiratory pressure, success rate for insertion, ease for insertion, ease for gastric tube insertion and fiberoptic bronchoscopic views will be compared between two groups.


Eligibility criteria: Inclusion Criteria:

* Children \< 7 years old who scheduled for general anesthesia using supraglottic airway

Exclusion Criteria:

* Children who require tracheal intubation
* Emergency operation without nil per os
* History of C-spine surgery or disease
* History of Esophageal disease or surgery

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: 30 seconds after AuraGain or I-gel insertion
Secondary outcomes:
measure: Peak inspiratory pressure
timeFrame: through study completion, an average of 1 hour
measure: Success rate
timeFrame: Within 5 minutes after anesthetic induction
measure: Ease of AuraGain or I-gel insertion
timeFrame: Within 5 minutes after anesthetic induction
measure: Ease of gastric tube insertion
timeFrame: Within 5 minutes after anesthetic induction
measure: fiberoptic bronchoscopic veiw
timeFrame: Within 10 minutes after anesthetic induction
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01822145: A Feasibility Study on Prediction of an ICD Shock by ICD-derived Data
Official title: PREDICTion of Implantable-Cardioverter Defibrillator Shock Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sudden Cardiac Arrest
Ventricular Tachycardia
Ventricular Fibrillation
Keywords: implantable-cardioverter-defibrillator
ventricular tachycardia
ventricular fibrillation
sudden cardiac arrest
Lead sponsor: Princess Margaret Hospital, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2013-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICD recipients with documented cardiac arrest, ventricular tachycardia or ventricular fibrillation

Brief summary: The primary hypothesis is that an ICD shock may be predicted days in advance by a combined score derived from different data obtainable from the ICD


Eligibility criteria: Inclusion Criteria:

1. Age ≧ 18 and ≦ 80
2. Patients have documented spontaneous and sustained ventricular arrhythmias in the last six months prior to the enrollment
3. Patients who are in sinus rhythm, have dual-chamber ICD or CRT-D implanted at least one month before enrollment
4. Patients who are in atrial fibrillation, have single-chamber ICD or CRT-D implanted at least one month before enrollment
5. Patients who are compliant to CareLink follow-up

Exclusion Criteria:

1. Patients who are pregnant
2. Patients who are incapable of giving consent to the study
3. Patients who have a life-expectancy of less than 2 years

Primary outcomes:
measure: ICD-derived T-wave alternans amplitude before ICD shock
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Princess Margaret Hospital
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Ngai Yin Chan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06288945: Effect of an Educational Program on Health-related Outcomes of Patients With Dry Eye Syndrome
Official title: Effect of an Educational Program on Health-related Outcomes of Patients With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dry eye syndrome (DES) is a widespread ocular disease affecting the general population. It is a complex disorder affecting the surface of the eye, marked by an imbalance in the tear film and ocular symptoms. Therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with DES including the severity of symptoms related to DES and their influence on visual-related functions

Detailed description: Dry eye syndrome (DES) is a prevalent chronic, inflammation resulting in eye discomfort, irritation, tiredness, and visual abnormalities that can make it difficult to read, use a computer, drive, or engage in other activities (1). It represents a set of tears film disorders caused by decreased tears formation or increased tears evaporation; it causes visual symptoms, ocular surface inflammation, and discomfort. In addition, DES leads to impaired visual function and can negatively affect the outcomes of cataract surgery (2).Therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with DES including the severity of symptoms related to DES and their influence on visual-related functions

Eligibility criteria: Inclusion Criteria:

* Age: 20 to 60 years old.
* Alert, and able to communicate.

Exclusion Criteria:

* patients with recent ocular surgeries in the last 3 months

Primary outcomes:
measure: ocular irritation symptoms associated with Dry eye syndrome and their effect on functions related to vision
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing, Alexandria university
Study officials:
References:
citation: Al-Mohtaseb Z, Schachter S, Shen Lee B, Garlich J, Trattler W. The Relationship Between Dry Eye Disease and Digital Screen Use. Clin Ophthalmol. 2021 Sep 10;15:3811-3820. doi: 10.2147/OPTH.S321591. eCollection 2021.
citation: Akpek EK, Amescua G, Farid M, Garcia-Ferrer FJ, Lin A, Rhee MK, Varu DM, Musch DC, Dunn SP, Mah FS; American Academy of Ophthalmology Preferred Practice Pattern Cornea and External Disease Panel. Dry Eye Syndrome Preferred Practice Pattern(R). Ophthalmology. 2019 Jan;126(1):P286-P334. doi: 10.1016/j.ophtha.2018.10.023. Epub 2018 Oct 23. No abstract available.
Clinical trial NCT00839345: Clopidogrel Resistance and the Possibility of Its Affection
Official title: Resistance to Antiplatelet Agents, Its Etiology and the Possibility of Its Affection
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Coronary Artery Disease
Keywords: platelet
clopidogrel
VerifyNow
ticlopidine
thrombosis
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2009-02-09
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of the study is to determine, whether the resistance to clopidogrel could be affected by higher doses of this drug, or by replacement of clopidogrel with another ADP-antagonist ticlopidine.

Detailed description: Patients after percutaneous coronary intervention (PCI) with stent implantation have to be treated by dual antiplatelet therapy, which standard part represents clopidogrel. The response to clopidogrel in population exhibits wide interindividual variability. According to some recent works, patients with clopidogrel resistance are in higher risk for recurrence of myocardial infarction in comparison with the patients with sufficient clopidogrel effectiveness. The treatment of clopidogrel resistance is still unknown. Our project should contribute to the better understanding of the clinical impact of clopidogrel resistance and its genetical determination. We will test the hypothesis, whether the clopidogrel resistance could be influenced by higher dose of this drug or by replacement to ticlopidine (ADP antagonist with different biotransformation in the liver). Therefore, 500 pts. will be tested to clopidogrel resistance. We expect 5-10% of resistent pts. This pts. will be treated by higher dose (150mg or 225mg/day) with repeated tests of clopidogrel effectiveness after each dose enhancement. If 225mg/day will be insufficient, clopidogrel will be replaced by ticlopidine with repeated test. We expect, that better definition of clinical and and genetic correlate of clopidogrel resistance will improve our knowledge of this disorder. Nevertheless, the achievement of sufficient effect of clopidogrel in some still resistant patients will lead to the improvement of the treatment

Eligibility criteria: Inclusion Criteria:

* written informed consent
* coronary artery disease verified by coronary angiography
* percutaneous coronary intervention with stent implantation
* standard indication for dual antiplatelet therapy

Exclusion Criteria:

* scheduled surgical revascularization by aortocoronary bypass
* insufficient cooperation of the patient
* coagulopathy in history with a higher risk of bleeding
* life expectancy shorter than 1 year
* severe anemia with hemoglobin level\< 10,0 g/dl
* platelet count \< 100,000)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Cardiocenter, Dept. Of Cardiology, Charles University Hospital
Study officials:
References:
Clinical trial NCT02898545: Recurrent Atrial Fibrillation
Official title: Recurrent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study will evaluate the recurrence rates of atrial fibrillation that develops in the hospital following non cardiac procedures or surgeries or acute medical illnesses.

Detailed description: Eligible individuals with no previous history of atrial fibrillation or flutter who develop a limited episode of atrial fibrillation during a hospital stay for an acute medical illness or non-cardiothoracic surgery or procedure. Patients will be monitored for a period of 1 month using Medtronic SEEQ monitors for recurrence. Subjects will self assign to wear the SEEQ monitor or standard of care. Individuals with implanted cardiac devices capable of detecting atrial fibrillation will also be included.

Eligibility criteria: Inclusion Criteria:

* Development of atrial fibrillation or flutter during a hospital stay following a non-cardiac procedure or acute medical illness
* CHADS2VASc score of 2 or more

Exclusion Criteria:

* Prior history of atrial fibrillation of flutter
* Requiring ventilator support or in shock
* Acute decompensated heart failure or EF =/\< 40%
* Greater than mild valvular heart disease
* Other structural heart disease such as more than mild LVH, constrictive or restrictive cardiomyopathy
* Hyperthyroidism uncontrolled at the time of diagnosis if known
* Pulmonary embolism that requires thrombolysis or resulted in shock
* Use of antiarrhythmic drugs (class I or III) at the time of discharge
* Cardiothoracic surgery in the last 6 months

Primary outcomes:
measure: Recurrence of atrial fibrillation
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Mehran Attari, MD
role: PRINCIPAL_INVESTIGATOR
References: