louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04933526: The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in CML-CP Patients
Official title: The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in Patients With Chronic Myeloid Leukemia in Chronic Phase: an Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Myeloid Leukemia in Chronic Phase
Keywords: Chronic Myeloid Leukemia in Chronic Phase
Imatinib
Flumatinib
Dasatinib
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 118
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 purpose of this study is to explore the efficacy and safety of switching to flumatinib versus dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase (CML-CP) in China. This is a post-marketing, interventional, double-arm, prospective, open-label, randomized controlled study in CML-CP patients in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given flumatinib or dasatinib under the conditions of informed consent and frequent monitoring according to the clinical guideline.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Diagnosis of CML-CP with Ph+;
* ECOG 0, 1, or 2;
* Patients with imatinib-related Low-grade Adverse Events for more than 12 months and AE lasting for at least 2 months, or relapsed at least 3 times in the past 12 months;
* Ability to provide written informed consent prior to any study related screening procedures being done

Exclusion Criteria:

* Previously documented T315I mutation;
* Previous treatment with any other tyrosine kinase inhibitor except for imatinib;
* Prior accelerated phase or blast phase CML;
* Loss of CHR or cytogenetic response

Primary outcomes:
measure: Change of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with flumatinib or dasatinib at 3 months.
timeFrame: 3 months
Secondary outcomes:
measure: Rate of a Major Molecular Response (MMR) after the switch to flumatinib or dasatinibin the therapy.
timeFrame: 12 months
measure: Time to optimal imatinib-related adverse event improvement.
timeFrame: 12 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT03356626: Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy
Official title: Comparison of Perioperative Outcomes Between Bipolar Sealing Device and Ultrasonic Shears During Laparoscopic Gastrectomy for Early Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Inflammation
Postoperative Fever
Keywords: fever, inflammation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic Spine LLC
First posted: 2017-11-29
Enrollment: 189
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat

comparing postoperative CRP level in each group

Detailed description: To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat

comparing postoperative CRP level in each group

1. post operative 2nd day CRP level
2. post operative 4th day CRP level
3. post operative IL-6, 10 level in 2nd, 4th day

Eligibility criteria: Inclusion Criteria:

* pathologically proven adenocarcinoma in stomach
* patients who are expected for R0 resection with distal gastrectomy
* pre-operative clinical stage should be stage I
* patients who is able to be followed up with in postoperative 30 days
* patients whose CRP is normal before surgery

Exclusion Criteria:

* patients who had an abdominal surgery
* patients who received chemotherapy, radiotherapy before surgery
* patients who received ESD before surgery
* Patients who had an ascites on pre-operative CT scan
* liver cirrhosis
* cardiovascular disease (Ejection Fraction\<50%)
* serum creatinine \> 1.4 mg/dL or BUN\>26mg/dL
* PT INR \>1.2 or aPTT\>45sec
* uncontrolled diabetes
* Crohn's disease, ulcerative colitis
* patients who receives anti-coagulants
* patients who need pre-operative steroid booster because of steroid treatment
* pregnancy
* patients who have allergic reaction to iodine

Primary outcomes:
measure: Postoperative 2nd Day CRP
timeFrame: 2nd day
Secondary outcomes:
measure: Postoperative 4th Day CRP
timeFrame: 4th day
measure: Postoperative 2nd Day IL-6
timeFrame: 2nd day
measure: Postoperative 4th Day IL-6
timeFrame: 4th day
measure: Postoperative 2nd Day IL-10 Level
timeFrame: 2nd day
measure: Postoperative 4th Day IL-10 Level
timeFrame: 4th day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seong-Ho Kong, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02728726: Sugammadex vs Placebo to Prevent Residual Neuromuscular Block
Official title: Randomized Double---Blinded, Controlled Trial to Compare the Effectiveness of Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post---Anesthesia Care Unit as Evaluated With a Non---Invasive Respiratory Volume Monitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: General Surgery
Keywords: Postoperative respiratory depression
Neuromuscular Agents
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: University of Texas
name: Respiratory Motion, Inc.
First posted: 2016-04-05
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery with general anesthesia
* Patients weighing \> or = 80 pounds
* Patients not intubated prior to surgery
* Patients who are able to give informed consent

Exclusion Criteria:

* Patients unable to give informed consent.
* Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron
* Patients who are anticipated to remain intubated in recovery period.

Primary outcomes:
measure: Decreased Minute Ventilation (MV)
timeFrame: 15---30 minutes after Post-anesthesia care unit (PACU) arrival
measure: Decreased Average Minute Ventilation (MV)
timeFrame: 15---30 minutes after Post-anesthesia care unit (PACU) arrival
Secondary outcomes:
measure: Train of Four (TOF) Ratio
timeFrame: upon PACU discharge, approximately 8 hours
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Houston
country: United States
facility: The University of Texas, UTHealth
state: Texas
Study officials:
affiliation: Mayo Clinic
name: J Ross Renew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02714465: Adverse Radiation Effects After Gamma Knife Radio Surgery and Hyperbaric Oxygen Therapy
Official title: Treatment of Adverse Radiation Effects After Gamma Knife Radiosurgery (GKS) by Hyperbaric Oxygen Therapy (HBO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Necrosis
Keywords: Hyperbaric Oxygen Therapy; Gamma Knife Radiosurgery
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 65
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of clinical improvement and the reduction of edema lesion documented by magnetic resonance imaging (MRI) in patients with cerebral radiation necrosis post gamma knife surgery (GKS) by treatment with hyperbaric oxygen therapy (HBO)

Detailed description: Patients will be recruited on the basis of the presence of cerebral radionecrosis post gamma knife surgery, documented by both clinical examination (Rankin Scale) and instrumental imaging (MRI). They will be subjected to hyperbaric oxygen therapy HBO, and during treatment the patient performs clinical examination (Rankin Scale) for 24 sessions of HBO. Then they will have a break of 10-15 days during which also performs the instrumental survey (Magnetic Resonance Imaging). If the radionecrosis has regressed they will suspend the treatment otherwise continue up to a maximum of 40 treatment sessions of HBO

Eligibility criteria: Inclusion Criteria:

* between 10 and 75 years
* understanding of the Italian language
* ability to understand the procedures and carrying out of the study
* signing informed consent for adults and minors in use
* underwent radiosurgery with clinical and instrumental signs of radiation necrosis

Exclusion Criteria:

* younger than 10yrs old and older than 75yrs old
* not capable to understand Italian language or to understand the protocol procedures and visits' scheme
* informed consent not given
* enrolled in another clinical trial
* concomitant pathologies contraindicate HBO as: emphysema, asthma, epilepsy, claustrophobia; Paul Bert Syndrome, Lorrain Smith Syndrome
* under disulfiram, doxorubicine, cisplatinum, mafenide acetate, bleomycins treatment
* life expectancy less than 6 months
* Rankin Scale \>5

Primary outcomes:
measure: Evaluation of clinical improvement
timeFrame: day 2 through day 25
Secondary outcomes:
measure: Evaluation of the reduction of the extent of edema lesion documented by MRI
timeFrame: 1-3 months
measure: Measurement of complications from hyperbaric oxygen therapy and their severity
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: Lombardia
Study officials:
References:
Clinical trial NCT04499365: 68Ga-FAPI PET/CT in Patients With Various Types of Cancer
Official title: 68Ga-DOTA/NOTA-FAPI-04 PET/CT in Patients With Various Types of Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Tumor
Positron-Emission Tomography
Metastasis
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Detailed description: Subjects with various types of cancer underwent 68Ga-DOTA/NOTA-FAPI-04 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.

Eligibility criteria: Inclusion Criteria:

* (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References:
citation: Chen Y, Zheng S, Zhang J, Yao S, Miao W. 68Ga-DOTA-FAPI-04 PET/CT imaging in radioiodine-refractory differentiated thyroid cancer (RR-DTC) patients. Ann Nucl Med. 2022 Jul;36(7):610-622. doi: 10.1007/s12149-022-01742-8. Epub 2022 May 12.
citation: Zheng S, Lin R, Chen S, Zheng J, Lin Z, Zhang Y, Xue Q, Chen Y, Zhang J, Lin K, You X, Yao S, Miao W. Characterization of the benign lesions with increased 68Ga-FAPI-04 uptake in PET/CT. Ann Nucl Med. 2021 Dec;35(12):1312-1320. doi: 10.1007/s12149-021-01673-w. Epub 2021 Aug 23.
Clinical trial NCT04110665: Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery
Official title: Evaluation of Multimodal Oral Strategies Using Sequential Analysis (Tramadol, Opioid) After Shoulder Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tendon Injuries
Keywords: shoulder
surgery
analgesia
opioid
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Evaluation of the treatment based on QoR40 survey every 20 patients
Primary purpose: TREATMENT

Brief summary: This study evaluates the addition of tramadol, or nefopam or opioid to paracetamol and ketoprofene in the treatment of pain in adults after shoulder ambulatory surgery. In a first step, 30 patients will receive tramadol as rescue analgesia in combination with paracetamol and ketoprofene, while the other will receive nefopam or opioid in a sequential analysis that will be performed every 20 patients using the QoR 40 survey.

Detailed description: Multimodal analgesia using acetaminophen with non steroidal anti inflammatory is commonly used for pain relief after ambulatory surgery. Tramadol achieves pain relief when rescue analgesia is needed after this surgery, but induces side effects (nausea, vomiting, discomfort, sleep disorder...). Other drugs could be used to reduce the side effects of tramadol and improve postoperative experience : nefopam or opioid (immediate or delayed release medication). Using a survey that describes pain, comfort, emotion or physical status (QoR 40), the investigators analyse the impact of various multimodal strategies using tramadol or nefopam or opioid that is necessary to improve postoperative experience.

Eligibility criteria: Inclusion Criteria:

* shoulder surgery
* under general anesthesia with an nterscalenic block
* written informed consent
* age \> 18 years

Exclusion Criteria:

* age \< 18years
* emergency surgery
* refusal
* drug or opioid abuses

Primary outcomes:
measure: Quality of Recovery (QoR) 40 survey
timeFrame: Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes, Nimes University, France
name: benjamin Garnaud, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00347165: Intravitreal Bevacizumab for Age-Related Macular Degeneration
Official title: Intravitreal Bevacizumab Therapy for Neovascular Age-Related Macular Degeneration: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Age Related Macular Degeneration
Keywords: macular degeneration
angiogenesis
antibodies
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intravitreal injection of bevacizumab is effective in the treatment of neovascular age related macular degeneration

Detailed description: The neovascular age related macular degeneration(AMD) is a important cause of legal blindness in adults older than 50 years. Currently the treatment is photodynamic therapy that offer stabilization and limited visual improvement after 2 years of therapy. Bevacizumab has been reported effective used as intravenous injection for AMD. But serious side effects have been reported with the use of this drug in oncologic patients. The intravitreal use has been reported in limited case reports and safety and efficacy should be determined.

The purpose of this study is efficacy and safety of 2.5 mg intravitreal of bevacizumab for AMD

Eligibility criteria: Inclusion Criteria:

* age \>50 age related macular degeneration

Exclusion Criteria:

* moderate to severe cataract glaucoma intraocular surgery diabetes mellitus non controlled hypertension coronary artery disease

Primary outcomes:
measure: Improvement of visual acuity at 6 months
Secondary outcomes:
measure: Retinal thickness at 6 months
measure: Leakiness in fluorangiography at 6 months
Other outcomes:
Locations:
city: MExico city
country: Mexico
facility: Hospital Luis Sanchez Bulnes
state: DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Hugo Quiroz-Mercado, MD
role: STUDY_CHAIR
References:
citation: Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):331-5.
Clinical trial NCT06965166: Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
Official title: Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proven rectal cancer clinically referred for staging pelvic MR and contrast-enhanced CT of the abdomen and pelvis.

Brief summary: This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.


Eligibility criteria: Inclusion Criteria:

* Adult patients 18 to 99 years of age
* Patients with proven rectal cancer clinically referred for staging pelvic MRI and contrast-enhanced CT of the abdomen and pelvis (for evaluation of liver and peritoneal disease)
* Endoscopic or imaging report that tumor is 2 cm or larger
* Patients who are able and willing to sign the informed consent
* Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient)

Exclusion Criteria:

* Minors less than 18 years old
* Known mucinous adenocarcinoma (may not enhance well)
* Patient unable to provide written informed consent
* Pregnancy
* estimated Glomerular Filtration Rate (eGFR) ≤ 60
* History of prior moderate or severe contrast reaction including unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis
* Any history of premedication prior to iodinated contrast
* Hip replacement/prosthesis
* Patients that consent to participation but do not undergo their clinically indicated MRI scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication)

Primary outcomes:
measure: Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvement
timeFrame: Baseline (after research CT scan has been performed)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Joel G. Fletcher, MD
role: PRINCIPAL_INVESTIGATOR
References: