louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01189435: Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib
Official title: A Phase 2 Trial of Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: OSI-774, TARCEVA (ERLOTINIB)
Lung
recurrent
10-097
Gefitinib
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-08-26
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the ability of erlotinib to effectively treat recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with erlotinib or gefitinib received in the post-surgical or post-radiation setting.


Eligibility criteria: Inclusion Criteria:

* A history of stage I-IIIB NSCLC
* Previously underdone definitive surgery or radiation
* Received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a total of at least 3 months at any time
* Stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first imaging demonstrating recurrence
* Pathologic evidence of recurrent lung cancer, confirmed at MSKCC EGFR sensitizing mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented in the primary or recurrent tumor
* Tissue from their recurrent tumor must be submitted for EGFR mutation testing, and to evaluate for the presence of the T790M mutation (results do not need to have been reported to be eligible)
* Measurable disease by RECIST; if received prior irradiation, then must have a target lesion outside the irradiated field
* Signed informed consent
* Age \> or = to 21 years old
* Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped

Exclusion Criteria:

* Prior progressive disease while receiving erlotinib or gefitinib therapy
* Patients with known pre-existing interstitial lung disease
* Total bilirubin greater than 1.8 mg/dl, excepting patients known to have Gilbert's syndrome
* AST or ALT greater than five times the upper limit of normal
* Pregnant or lactating women
* Medically unfit for erlotinib therapy as determined by treating oncologist

Primary outcomes:
measure: To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christopher Azzoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615835: EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant
Official title: Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-06-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Use of the EnSite NavX system to map the coronary vasculature during CRT implant

Detailed description: Objective(s):

To determine the feasibility of CS mapping with NavX during Biventricular Implantable Cardioverter Defibrillator (BiV ICD) implantation.

Inclusion Criteria:

* Subject is between the age of 18 and 75 years
* Subject is willing and able to sign a study specific informed consent
* Subject is able to fulfill study requirements
* Meet the conventional criteria for implant of a BiV ICD, including; LVEF of ≤35%, QRS ≥ 120 ms and NYHA III-IV
* Have persistent CHF symptoms despite contemporary CHF medical therapy
* Stable and optimal medical therapy (stability is no changes in past 3 months).
* Documented history of ischemic or non-ischemic cardiomyopathy.

Exclusion Criteria:

* Have any standard device exclusions including tricuspid valve prosthesis/ replacement.
* Have a positive urine or serum pregnancy test (if female and of childbearing potential)
* Be currently participating in an IDE or IND study.

Eligibility criteria: Inclusion Criteria:

* Meet criteria for CRT implant including EF\<35%, QRS\>120ms, NYHA class III or IV
* Persistent CHF symptoms despite optimization
* Stable/optimal medical therapy
* History of ischemic or non-ischemic cardiomyopathy

Exclusion Criteria:

* Any standard device exclusion including TVR
* Positive pregnancy test
* Currently participating in IDE/IND study

Primary outcomes:
measure: Determine feasibility of CS mapping with EnSite NavX during CRT implant
timeFrame: Procedural
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
Study officials:
affiliation: Augusta University
name: Adam Berman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02932735: The Efficacy of Probe-based Confocal Laser Endomicroscopy in Staging OLGIM
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Probe-based Confocal Laser Endomicroscopy
the Operative Link on Gastric Intestinal Metaplasia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients scheduled for pCLE examination will be recruited in this study at Qilu Hospital, Shandong University.

Brief summary: Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 40 years or older with Helicobacter pylori infection;
* Histologically verified GIM, atrophic gastritis or dysplasia.

Exclusion Criteria:

* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
* Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium;
* Pregnancy or breastfeeding;
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Primary outcomes:
measure: the sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM).
timeFrame: 6 months
measure: the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM).
timeFrame: 6 months
Secondary outcomes:
measure: the of sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM).
timeFrame: 6 months
measure: the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM).
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Li Yanqing, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03136835: Maternal Hyperoxygenation in Congenital Heart Disease
Official title: Maternal Hyperoxygenation in Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypoplastic Left Heart Syndrome
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pilot study investigating the safety and feasibility of chronic maternal hyperoxygenation in the setting of fetal congenital heart disease

Detailed description: The aim of the study is to investigate the safety and feasibility of chronic maternal hyperoxygenation in pregnancies affected by fetal congenital heart disease, specifically those pregnancies in which the fetus has single ventricle physiology with aortic arch obstruction. The treatment has a potentially neuroprotective effect on the fetus. This would be desirable as the neurodevelopmental outcomes of the survivors of this form of congenital heart disease are significantly below normal. However, transplacental oxygen has not been tried in this setting, and so before embarking on a trial, the investigators need to establish that the treatment is safe and feasible. This will be accomplished by recruiting subjects which meet the eligibility criteria and commence treatment at the time of diagnosis, usually in the second trimester, and by comparing outcomes with a historical cohort with CHD diagnoses with no oxygen intervention. The oxygen will be delivered to the mother via nasal prongs continuously at a rate of up to 4 L/min. Oxygen concentrators will be supplied to the subjects' homes, and a range of portable devices will also be provided to allow them to continue with usual activities of daily living. A series of follow up appointments will be arranged to check the status of the mother and fetus. Mothers will be invited to keep a diary of their adherence to the treatment. A range of routine clinical and research data on the condition of the fetus and newborn will be collected.

Eligibility criteria: Inclusion Criteria:

* Between 20-32 weeks gestation
* Diagnosis of fetus with a single ventricular ventricular heart
* Delivering at Mount Sinai Hospital
* Written informed consent

Exclusion Criteria:

* Opting for termination of pregnancy/ comfort care
* Normal exclusions for MRI (e.g. claustrophobia, cardiac pacemaker, etc.)
* BMI \>37.0
* Infections/ anemia
* Smoker
* Serious cardiorespiratory co-morbidities

Primary outcomes:
measure: The general condition of the child and mother at the time of birth
timeFrame: 2 years
measure: The duration of oxygen therapy tolerated by the subjects
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Mike Seed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03806335: The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy
Official title: The Effect of Local Infiltration Technique on Postoperative Pain After Adult Tonsillectomy: A Randomized Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Tonsillectomy is commonly associated with postoperative pain. The modified pre-incision infiltration of anesthetic mixture combined with general anesthesia was shown to decrease post-tonsillectomy pain in children. Hence, the present clinical trial will assess the effectiveness of this technique in adults undergoing tonsillectomy.

Detailed description: The study will be conducted prospectively, using a randomized double-blind design. Adult patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting from January 2019 till January 2020 will be included.Patients will be allocated randomly into two equal groups using the sealed envelope method. Both groups will receive general anesthesia. Then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. The second group will have placebo infiltration.

Eligibility criteria: Inclusion Criteria:

* patients with total or partial tonsillectomy with or without adenoidectomy

Exclusion Criteria:

* patients who took antiemetics, steroids, or antihistaminics within 24 hours before surgery. - patients who have asthma
* patients who have diabetes
* patients who have bleeding problems
* patients who are suspected to have signs of acute pharyngeal infection

Primary outcomes:
measure: Post operative pain
timeFrame: within 10 days after the operation
Secondary outcomes:
measure: PONV
timeFrame: within 10 days after the operation
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Zoher Naja
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02568735: Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty
Official title: The Central Nervous Penetration of Dexketoprofen and Etoricoxib and Their Effect on Pain and Inflammatory Reaction in Patients Undergoing Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Dexketoprofen
Etoricoxib
hip arthroplasty
pain
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study was to determine the plasma and central nervious system pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their efficacy in postoperative pain treatment.


Eligibility criteria: Inclusion Criteria:

* agreed to participate the study
* American Society of Anesthesiologist s physical status classification 1-3
* elective hip arthroplasty planned
* no contraindications to the study drugs
* no contraindication to lumbar puncture

Exclusion Criteria:

* refused to participate the study
* age less than 40 or over 75 years
* Planned anesthesia method other than spinal anesthesia
* contraindications to the study drugs
* Contraindications to lumbar puncture

Primary outcomes:
measure: Cerebrospinal fluid concentration dexketoprofen and etoricoxib
timeFrame: 0-24 hours
measure: Plasma concentration dexketoprofen and etoricoxib
timeFrame: 0-24 hours
Secondary outcomes:
measure: Pain
timeFrame: 0-24 h
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00159458: Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer
Official title: Phase II Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent Breast Cancer
Metastastic Breast Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if the combination of gemcitabine and oxaliplatin chemotherapy will be effective in reducing or eliminating the tumor(s) in patients with recurrent or metastatic breast cancer.

Gemcitabine is a chemotherapy drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic and lung cancer; oxaliplatin is a chemotherapy drug that is approved by the FDA for the treatment of colon cancer. Neither gemcitabine nor oxaliplatin are approved for the treatment of breast cancer. However, both drugs have been shown to decrease the size of breast cancer tumors.


Eligibility criteria: Inclusion Criteria:

* Histologically proven dx of recurrent or metastatic breast cancer
* Must have received at least 1 but not more than 3 prior chemotherapy regimens for recurrent or metastatic breast cancer. Patients who relapse within 12 months of completing adjuvant chemotherapy can only have had up to 2 prior regimens for metastatic disease. Patients who relapse within 12 months of completing adjuvant chemotherapy containing an anthracycline and a taxane, do not require prior chemotherapy for metastatic disease.
* Unidimensionally measurable dz (by RECIST)
* At least 18 yrs of age
* SWOG PS 0-2
* AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb greater than or equal to 8.0
* Total bilirubin less than or equal to 2 x uln; SGOT and/or SGPT and alk phos up to 2.5 x uln
* Creatinine less than or equal to 2.0
* Fully recovered from acute toxicities secondary to prior tx
* Signed informed consent (including HIPAA authorization)
* Peripheral neuropathy grade 0-1

Exclusion Criteria

* Prior tx with gemcitabine or oxaliplatin. Prior tx with cisplatin or carboplatin allowed if completed \>12 mos prior to enrollment.
* Underlying medical, psychiatric, or social conditions that would preclude patient from receiving tx
* Peripheral neuropathy greater than or equal to Gr 2

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Norris Comprehensive Cancer Center
state: California
city: Santa Monica
country: United States
facility: Premiere Oncology
state: California
Study officials:
affiliation: LAC+USC Medical Center
name: Christy Russell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01072058: Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
Official title: Prospective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Spondylitis, Ankylosing
Keywords: Infliximab
Adalimumab
Etanercept
Heart failure
Diastolic disfunction
TNF blocker
Anti-TNF
Echocardiography
Tissue doppler imaging
Brain Natriuretic Peptide
NT-proBNP
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-02-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine possible alterations in cardiac function in patients with Rheumatoid Arthritis and Ankylosing Spondylitis under anti-TNF therapy, without clinical heart disfunction at baseline, using highly sensitive non-invasive methods.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis eligible to receive TNF blockers
* Diagnosis of Ankylosing Spondylitis eligible to receive TNF blockers

Exclusion Criteria:

* Clinical heart failure
* Chagas'disease
* Stable or unstable angina
* Past history of myocardial infarct
* Systemic árterial hypertension (grade 3)
* Valvulopathy
* Chronic kidney disease

Primary outcomes:
measure: Development, deterioration ou improvement of subclinical heart dysfunction
timeFrame: 0, 6 ,12, 18 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo
Study officials:
name: Eloisa S.D.O. Bonfá, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06253858: Ultrasound (US) Guided External Ventricular Catheter Placement
Official title: Ultrasound (US) Guided External Ventricular Catheter Placement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hydrocephalus
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the accuracy the SOLOPASS® System US based in the placement of external ventricular drain into the cranial cavity. This study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.


Eligibility criteria: Inclusion Criteria:

* Decision made to perform the procedure by the primary consultant
* Age 18 or older
* Neuro ICU stay
* Newly diagnosed hydrocephalus
* Has a recent CT within the past 24 hrs
* Normal platelets and coagulation profile
* No active infection or currently on antibiotics
* The targeted fluid compartment has more than 50 percent CSF vs blood by CT scan imaging

Exclusion Criteria:

* Age \<18
* Not in Neuro ICU setting
* Previous placement of a ventricular catheter
* More than 50 percent of the fluid compartment is filled with blood by CT scan
* Time to include in the trial prohibited by clinical personnel

Primary outcomes:
measure: Average number of passes needed to place the catheter in each subject.
timeFrame: 0 minutes
Secondary outcomes:
measure: Post procedure imaging accuracy of the placement of the EVD will be performed by reviewing post procedure imaging using the Kakarla scoring system
timeFrame: up to 7 days
Other outcomes:
measure: Length of time of the procedure
timeFrame: Up to three hours
measure: Number of revision
timeFrame: up to 7 days
measure: Number of subjects with Cerebrospinal fluid (CSF) infection
timeFrame: up to 7 days
measure: Number of subjects with Superficial surgical site infection (SSI)
timeFrame: up to 7 days
measure: Longevity of the device function
timeFrame: up to 7 days
Locations:
Study officials:
References: