louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03388372: Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma
Official title: Efficacy and Safety of Nimotuzumab in Addition to Radiotherapy and Temozolomide for Cerebral Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma
Keywords: glioma
phase 2
nimotozumab
temozolomide
radiotherapy
Lead sponsor: Biotech Pharmaceutical Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2018-01-03
Enrollment: 39
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: TREATMENT

Brief summary: This study aimed to investigate the clinical benefit contribution and safety of nimotuzumab to the standard combined treatment for patients with newly diagnosed glioblastoma.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed, histologically proven single supratentorial GBM (WHO grade 4);
* EGFR positive;
* \>50％ of the gross tumor volume removed by surgery；
* Karnofsky performance score (KPS) ≥ 60;
* Adequate renal function (creatinine ≤1.5×upper limit of normal \[ULN\] or creatinine clearance ≥ 60 mL/min), hepatic function (total bilirubin ≤1.5×ULN and serum transaminases ≤3×ULN), and hematologic function (white blood cell count ≥ 3,000/uL or absolute neutrophil count ≥ 1,500/uL, platelets ≥ 100,000/uL, and hemoglobin ≥ 10 g/dL).
* Tumor tissue was required for central pathology review and re-checking EGFR and MGMT expression status;
* An interval of 2 to 6 weeks between surgery and RT was required.

Exclusion Criteria:

* Negative EGFR expression;
* Prior chemotherapy, anti-EGFR therapy, RT, or a history of malignancy in the previous 5 years;
* Patients with severe complications or active infection;
* Continuous vomiting that could interfere with the oral administration of TMZ;
* Pregnancy

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 6 months
measure: Incidence of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangdong
country: China
facility: Guangdong Brain Hospital
city: Guangdong
country: China
facility: The First Affiliated Hospital/School of Clinical Medicine of Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
Study officials:
affiliation: Sun Yat-sen University
name: Shao-Xiong Wu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01693172: Effect of an Early Mobilization Program on Outcomes After Major Cancer Surgery
Official title: Effect of an Early Mobilization Program After Surgery on Functional Recovery and Clinical Complications in Patients Undergoing Major Cancer Surgey : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasm
Keywords: exercise
neoplasm
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the effect of an early postoperative physical rehabilitation program on the functional capacity and incidence of postoperative complications in patients undergoing major elective surgery for treatment of a neoplasm


Eligibility criteria: Inclusion Criteria:

* Patients who will be submitted to major surgery for cancer treatment.
* Age ≥ 18 years
* Reading and signing the informed consent

Exclusion Criteria:

Acute myocardial infarction (within the last 30 days)

* Unstable Angina
* Cardiac arrhythmia uncontrolled
* symptomatic severe aortic stenosis
* Congestive heart failure NYHA III or IV
* infarction or acute pulmonary thromboembolism
* pericarditis or myocarditis
* Acute Endocarditis
* Acute aortic dissection
* Active infection
* Acute renal failure
* Thyrotoxicosis
* Refusal to participate in the study
* Inability to ambulate independently and / or inability to exercises
* Presence of bone metastasis
* musculoskeletal and neurological conditions that preclude the achievement of an exercise program designed for this study

Primary outcomes:
measure: Ability to walk three meters or crossing a room without assistence
timeFrame: at 5 days after surgery or at hospital discharge
Secondary outcomes:
measure: fatigue
timeFrame: at 5 and 30 days after surgery
measure: quality of life
timeFrame: at 5, 30, 180 and 365 days after surgery
measure: length of hospital stay
timeFrame: at hospital discharge
measure: recurrence of cancer
timeFrame: at 180 days after surgery
measure: hospital costs
timeFrame: at 180 days after surgery
measure: post operatorative complications
timeFrame: at 30 days after surgery
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Câncer do Estado de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Ludhmila A Hajjar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Almeida EPM, de Almeida JP, Landoni G, Galas FRBG, Fukushima JT, Fominskiy E, de Brito CMM, Cavichio LBL, de Almeida LAA, Ribeiro U Jr, Osawa EA, Diz MP, Cecatto RB, Battistella LR, Hajjar LA. Early mobilization programme improves functional capacity after major abdominal cancer surgery: a randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):900-907. doi: 10.1093/bja/aex250.
Clinical trial NCT04217772: OCTA Analysis In Children After Lensectomy
Official title: Optical Coherence Tomography Angiography Analysis After Childhood Lensectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deprivation Amblyopia
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to quantify and compare the foveal avascular zone (FAZ), the parafoveal and foveal vessel density of superficial (SCP) and deep capillary plexus (DCP) and retinal thickness in deprivation amblyopic eyes, fellow non-amblyopic eyes, and age-matched normal eyes, using optical coherence tomography angiography (OCTA). The FAZ, parafoveal and foveal SCP and DCP, and retinal thickness were measured in normal controls and at least 3 months postoperatively in children with unilateral cataract and compared between groups after adjusting for axial length and spherical equivalents.


Eligibility criteria: Inclusion Criteria:

* children after cataract surgery and healthy volunteers

Exclusion Criteria:

* presence of corneal opacity preventing detailed imaging
* nystagmus
* retinal disease,
* persistent fetal vasculature
* intraocular inflammation,
* glaucoma
* vitreoretinal surgery
* premature birth
* neurologic disease
* systemic disease that could alter microvasculature (including diabetes, hypertension, cardiovascular disease and renal disease)

Primary outcomes:
measure: Foveal retinal thickness
timeFrame: up to 36 months
measure: Area of foveal avascular zone
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Eye Hospital of WMU
state: Zhejiang
city: Wenzhou
country: China
facility: The affiliated Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Eye Hospital of WMU
name: Yune Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02253472: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder
Official title: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
First posted: 2014-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is To verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Obsessive-Compulsive Disorder.


Eligibility criteria: Inclusion Criteria:

1. Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis.
2. Severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale.
3. Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance).
4. Treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in 5.Sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic Lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including "exposure and response Prevention" of a minimum of 20 sessions with a documented lack of efficiency.

6.The ability to give written and informed consent.

Exclusion Criteria:

1. Co-morbid psychotic disorder according to DSM-IV criteria
2. Suicidal tendencies in the last 6 months
3. History of cerebral trauma
4. Clinically relevant internal or neurological disorder
5. Substance misuse or dependence in the last six months
6. Ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a DBS
7. Participate in other clinical trial
8. The investigator and/or enrollment review committee, would preclude participation in the study

Primary outcomes:
measure: Yale-Brown obsessive-compulsive psychiatrists rating scale(Y-BOCS)
timeFrame: 12 month
Secondary outcomes:
measure: Hamilton anxiety scale (HAMD)
timeFrame: 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Tsinghua University
name: Li Luming, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06417372: Intraoperative Fluorescent Staining Combined With Microsurgery for Gliomas
Official title: Prospective Study of the Effect of Intraoperative Fluorescent Staining Combined With Microscopy on the Prognosis of Patients With Gliomas
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioma
Keywords: glioma
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosed glioma patients who will undergo surgical treatment in the First Affiliated Hospital of Sun Yet-Sen Universtiy.

Brief summary: Through the modified formulation of sodium fluorescein and methylene blue, the surface of the suspected cut edge of the patient's glioma was stained intraoperatively, and the surgical microscope image acquisition and processing system was used to determine whether the cut edge of the surgically resected tissue was positive or not. And combined with the existing multimodal surgical techniques (imaging, electrophysiology, neuronavigation and other equipment), the glioma is precisely resected.


Eligibility criteria: Inclusion Criteria:

1. any gender, age 5-90 years old;
2. patients with a confirmed diagnosis of glioma (primary tumor or metastatic tumor) by imaging or biopsy;
3. patients who can tolerate the surgery by preoperative evaluation; the expected volume of tumor specimen to be resected intraoperatively is more than 1cm3;
4. subjects who voluntarily enroll in the study, sign the informed consent form, and have a good adherence to the study and cooperate with the follow-up visits;
5. patients with expected survival of not less than 12 months as judged by clinician; and 6. patients who are not in the clinical trial. The expected survival period, as judged by the clinician, is not less than 12 months.

Exclusion Criteria:

1. Serious or unstable diseases of the heart, lungs, kidneys and hematopoietic system that cannot tolerate surgery
2. Pregnant or lactating women
3. Other factors that, in the judgment of the investigator, could lead to termination of the study, such as other serious medical conditions or serious laboratory abnormalities or other family or social factors that would affect the safety of the subject or the collection of test data and samples.

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: From date of randomization until the date of first documented progression, assessed up to 12 months
measure: overall survival (OS)
timeFrame: From date of randomization until the date of death from any cause, assessed up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02444572: Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®
Official title: Comparison of Thromboembolic Events in Patients Undergoing Gastrointestinal Cancer Surgery and Thromboprophylactic Treatment With Two Enoxaparin Formulations (ENOXA® vs Lovenox®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Neoplasms
Thromboembolic Event
Keywords: Enoxaparin
Immunogenicity
Lead sponsor: Les Laboratoires des Médicaments Stériles
Sponsor class: INDUSTRY
First posted: 2015-05-14
Enrollment: 168
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective, monocentric, randomized, parallel group, rater-blinded study using two formulations of Enoxaparin sodium (ENOXA® vs LOVENOX®) to compare the thromboembolic events (symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and thromboprophylactic treatment with either Enoxaparin formulations.

The study has a secondary focus as to evaluate the immunogenicity of the two formulations of Enoxaparin through a subgroup analysis.

Study followup duration is up to 30 days post surgical procedure.


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years
* Gastrointestinal (GI) Cancer
* Elective or emergency surgery
* Preventive administration of enoxaparin sodium

Exclusion Criteria:

* Patients participating in another study
* Unfractionated heparin (UFH) use up to 30 days prior to surgical procedure
* Renal failure with creatinine clearance \<30 ml / min
* Known history of peripheral venous thrombosis and/or deep venous thrombosis in the 3 months prior to inclusion
* Pregnant or breastfeeding women or women of childbearing age not using medically accepted contraceptive method
* Anticoagulant use in the 3 months prior to inclusion
* Patients with known haemostatic disorder
* Patients not consenting to participate in the study, or not capable of understanding its objectives

Primary outcomes:
measure: Incidence of asymptomatic Deep Venous Thrombosis (DVT)
timeFrame: 7 - 10 days postoperative
Secondary outcomes:
measure: Incidence of symptomatic thromboembolic events
timeFrame: 30 days postoperative
measure: Number of adverse events
timeFrame: 30 days postoperative
measure: Incidence of both Enoxaparin formulations immunogenicity
timeFrame: 0 -10 days postoperative
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Charles Nicolle Hospital
state: Tunis BAB Souika
Study officials:
affiliation: Charles Nicolle Hospital
name: Chadli DZIRI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00562172: Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)
Official title: Lantus vs Sulfonylurea as add-on Therapy in Type 2 Diabetic Patients Failing Metformin Monotherapy: Comparison of Effects on Beta Cell Function and Metabolic Profile.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective:

To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients

Secondary objective:

To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment


Eligibility criteria: List of Inclusion and Exclusion Criteria:

Inclusion Criteria:

* Type 2 Diabetes Mellitus patients on metformin monotherapy
* 7% ≤ HbA1c ≤ 12%
* 20 kg/m² ≤BMI ≤ 35 kg/m²
* Diabetes duration: at least 6 months

Exclusion Criteria:

* Type 1 Diabetes Mellitus patients
* Clinical evidence of active liver disease, or serum Alanine AminoTransferase 3 times the upper limit of the normal range
* Serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females
* Acute and chronic metabolic acidosis, including diabetic ketoacidosis
* History of alcohol or other substance abuse
* Pregnancy or not using contraceptive in childbearing aged women
* Known hypersensitivity to Lantus, SU or metformin
* Any disease or condition that in the opinion of the investigator may interfere with completion of the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: ß-cell Function parameter
timeFrame: From the signature of the Informed Consent Form (ICF) up to the end of study
measure: Glucose Homeostasis and glycemic control status
timeFrame: From the signature of the Informed Consent Form (ICF) up to the end of study
Secondary outcomes:
measure: Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine
timeFrame: End of the study
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi
name: Ji Young Ahn
role: STUDY_DIRECTOR
References:
citation: Moon JS, Ha KS, Yoon JS, Lee HW, Lee HC, Won KC; BETA study group. The effect of glargine versus glimepiride on pancreatic beta-cell function in patients with type 2 diabetes uncontrolled on metformin monotherapy: open-label, randomized, controlled study. Acta Diabetol. 2014 Apr;51(2):277-85. doi: 10.1007/s00592-013-0553-z. Epub 2014 Jan 21.
Clinical trial NCT01794468: A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study
Official title: A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Positive-Pressure Respiration, Intrinsic
Critically Ill Patients
Keywords: Dermal blood flow
critically ill
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Background: Conditions of reduced perfusion are characterized by redistribution of blood flow away from the skin to more vital organs.

Study Objectives: To assess the efficacy of a non-invasive, dermal blood flow (DBF) monitor in detecting changes in perfusion in critically ill patients.

Preliminary Study

Study Population: critically ill patients in a general ICU

Detailed description: DBF, finger plethysmography and invasive mean arterial pressure (MAP) were recorded over an 8-hour period. DBF was measured using the I.S. MedTech DBF monitor, based on the hot-wire principle of thermal balance of a heater cooled by a moving medium, via a skin probe placed on the anterior chest wall. Sensitivity was evaluated by visual inspection during active states, either induced, e.g. fluid administration, or spontaneous, e.g. altered hemodynamics. Specificity was evaluated during stable states (minimal fluctuations of MAP and no active interventions applied or required). Data are expressed in terms of standard deviation (SD) and of the difference (SDD) between the MAP and each of the tested methods.

Eligibility criteria: Inclusion Criteria:

* All patients were ventilated and sedated during an 8-hour period of measurement

Exclusion Criteria:

* Age \< 18 years old

Primary outcomes:
measure: Dermal blood flow measurements
timeFrame: over an 8-hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: ICU dep't , Rabin MC
Study officials:
affiliation: ICU dep't, Rabin MC,Petah Tikva, Israel
name: Jonathan Cohen, Professor,MD
role: STUDY_CHAIR
affiliation: ICU dep't, Rabin MC,Petah Tikva, Israel
name: Pierre Singer, Professor,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00692068: Relations Between Residual Renal Function and Oxidative and Carbonyl Stress in Peritoneal Dialysis Patients
Official title: Relations Between Residual Renal Function and Oxidative and Carbonyl Stress in Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Failure
Keywords: residual renal function
oxidative stress
carbonyl stress
peritoneal dialysis
Lead sponsor: Iwata City Hospital
Sponsor class: OTHER
Collaborators: name: University of Shizuoka
name: Hamamatsu University
First posted: 2008-06-06
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: single dialysis center

Brief summary: Residual renal function is reported to contribute to the survival and cardiovascular disease of peritoneal dialysis patients. Oxidative and carbonyl stress are increased in peritoneal dialysis patients and are associated with cardiovascular risk. The aim of this study was to determine the relations between residual renal function and oxidative and carbonyl stress in peritoneal dialysis patients.


Eligibility criteria: Inclusion Criteria:

* chronic renal failure on peritoneal dialysis

Exclusion Criteria:

* malignancy, peritonitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Iwata
country: Japan
facility: Iwata City Hospital
state: Shizuoka
Study officials:
affiliation: Iwata City Hospital
name: Ryuichi Furuya, M.D.
role: STUDY_CHAIR
References: