louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01040013: Gut Oxygenation and Laparoscopy
Official title: GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Laparoscopy
Laparotomy
Oxygenation,
Ischemia-Reperfusion Injury
Keywords: LAPAROSCOPY,
LAPAROTOMY,
OXYGENATION,
ISCHEMIA-REPERFUSION INJURY
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2009-12-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with left-colon cancer will be randomized to laparoscopic or laparotomic operation. during surgery and for 6 days after operation, intestinal oxygen tension and ischemia-reperfusion injury markers will be evaluated to understand if pneumoperitoneum is associated with reduced splanchnic blood flow and ischemia-reperfusion injury.


Eligibility criteria: Inclusion Criteria:

* Proven Cleft Colon Cancer, Signed Informed Consent

Exclusion Criteria:

* Emergency surgery,
* Cancer infiltrating adjacent organ (at CT scan),
* Severe cardiovascular (New York Heart Association class \> 3 ),
* Respiratory (arterial PO2 \< 70 mmHg),
* Renal (plasma creatinine \> 3 MG/dL) or hepatic (Child C) dysfunction

Primary outcomes:
measure: Intestinal oxygenation
timeFrame: 7 DAYS
Secondary outcomes:
measure: Ischemic reperfusion injury
timeFrame: 7 DAYS
Other outcomes:
Locations:
city: Monza
country: Italy
facility: San Gerardo Hospital
Study officials:
affiliation: Milano-Bicocca university
name: Luca Gianotti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moore K, Roberts LJ 2nd. Measurement of lipid peroxidation. Free Radic Res. 1998 Jun;28(6):659-71. doi: 10.3109/10715769809065821.
citation: Gianotti L, Nespoli L, Rocchetti S, Vignali A, Nespoli A, Braga M. Gut oxygenation and oxidative damage during and after laparoscopic and open left-sided colon resection: a prospective, randomized, controlled clinical trial. Surg Endosc. 2011 Jun;25(6):1835-43. doi: 10.1007/s00464-010-1475-2. Epub 2010 Dec 7.
Clinical trial NCT04022213: A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum
Official title: Phase II Combination of 131I-Omburtamab Radioimmunotherapy and External Beam Radiotherapy for Desmoplastic Small Round Cell Tumor
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Desmoplastic Small Round Cell Tumor
Peritoneal Cancer
Peritoneal Carcinoma
Keywords: Solid Tumor
Peritoneal Solid Tumor
DSRC
I131-Omburtamab
Memorial Sloan Kettering Cancer Center
19-182
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Y-mAbs Therapeutics
First posted: 2019-07-17
Enrollment: 31
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test any good and bad effects of the study drug 131I-omburtamab. 131I-omburtamab could prevent the cancer from returning, or delay the cancer from getting worse, but it could also cause side effects. Researchers hope to learn more about how 131I-omburtamab works in the body, and how effective it is in treating cancer. 131I-Omburtamab is not approved by the FDA to treat DSRCT or other cancers of the peritoneum.


Eligibility criteria: Inclusion Criteria:

* Have the diagnosis of DSRCT confirmed at MSKCC
* Age \>1 year and able to cooperate with radiation safety restrictions during therapy period.
* Prior to intraperitoneal catheter placement

  * At least 1 weeks must have elapsed since prior chemotherapy
  * At least 2 weeks must have elapsed since biologic therapy
  * Toxicities of prior therapy must have resolved to grade 1 or less or to the patient's baseline

At the completion of surgery, patients must fulfill all of the additional following criteria:

* Have no definitive radiological evidence of disease active in liver or outside the abdomen/pelvic OR have had GTR of this disease at the time of catheter placement

Exclusion Criteria:

* Prior progression of disease
* Prior hypothermic intraperitoneal chemotherapy (HIPEC)
* Cardiac, pulmonary, and neurologic toxicities are greater grade 1 per NCI CTCAE version 5
* Renal, gastrointestinal, and hepatic, toxicities are greater than grade 2 (per NCI CTCAE version 5)
* History of allergy to mouse proteins
* Patients with grade 4 hypersensitivity reaction to radiolabeled iodine

Primary outcomes:
measure: Progression Free Survival/PFS
timeFrame: Up to 2 years after treatment is discontinued
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: Emily Slotkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366313: The Median Effective Dose (ED50) of Paracetamol and Morphine : A Study of Interaction Study
Official title: The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: paracetamol
morphine
median effective dose
pain
Lead sponsor: Procare Riaya Hospital
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 90
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 aim of our study is to define the median effective analgesic doses (ED50) of paracetamol, morphine, and their combination and determination the nature of their interaction administered IV for postoperative pain after moderate painful surgery using up-and-down and isobolographic methods.

Detailed description: Ninety patients scheduled to undergo moderately painful surgery were included in one of three groups. Determination of median effective (ED50) doses was performed by the Dixon and Mood up-and-down method. Initial doses were 1.5g and 5mg, with dose adjustment intervals of 0.5g and 1 mg, in the paracetamol and morphine groups, respectively. The initial doses of paracetamol and morphine were 1.5g and 3mg, respectively in the paracetamol-morphine combination group with dose adjustment intervals of 0.25g for paracetamol and 0.5mg for morphine. Analgesic efficacy was defined as a decrease to less than 3 on a 0-10 numeric pain scale, 45 min after the beginning of drug administration. Isobolographic analysis was used to define the nature of their interaction.

Eligibility criteria: Inclusion Criteria:

1. ASA physical status І or ІІ
2. Moderately painful surgery patients
3. postoperative pain more than 3 on a numerical pain score (NPS) -

Exclusion Criteria:

1. contraindication to the use of paracetamol and morphine
2. Pregnancy
3. age younger than 18 yr
4. patient weight less 65kg
5. intra-operative regional anesthesia,
6. intra-operative administration of analgesics other than fentanyl,
7. postoperative pain less than 3 on a numerical pain score (NPS)

Primary outcomes:
measure: ED50s of Paracetamol, morphine and their combination
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary outcomes:
measure: Paracetamol-Morphine interaction nature
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Other outcomes:
Locations:
city: Al Khobar
country: Saudi Arabia
facility: Procare Riaya Hospital
state: Estern
Study officials:
affiliation: Procare Riaya Hospital
name: AHED ZEIDAN, MD
role: STUDY_CHAIR
References:
citation: Zeidan A, Mazoit JX, Ali Abdullah M, Maaliki H, Ghattas T, Saifan A. Median effective dose (ED(5)(0)) of paracetamol and morphine for postoperative pain: a study of interaction. Br J Anaesth. 2014 Jan;112(1):118-23. doi: 10.1093/bja/aet306. Epub 2013 Oct 24.
Clinical trial NCT01920113: A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection
Keywords: Endoscopic submucosal dissection
propofol
remifentanil
dexmedetomidine
efficacy
safeness
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine is a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but it is limited to use alone. The investigators designed this study to compare the effect and safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal Dissection (ESD), when sufficient analgesia-remifentanil is administered all throughout the procedure.


Eligibility criteria: Inclusion Criteria:

* Age ≥20
* American Society of Anaesthesiologists(ASA) physical status classification I\~III
* Early gastric cancer patients who were scheduled for Endoscopic submucosal dissection

Exclusion Criteria:

* Age \< 20
* American Society of Anaesthesiologists(ASA) physical status classification IV
* those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
* known drug allergies or history of drug abuse
* psychological disease

Primary outcomes:
measure: A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
timeFrame: right after the drugs had administered
Secondary outcomes:
measure: A comparison of efficacy during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
timeFrame: right after the drugs had administered
Other outcomes:
measure: A comparison of patient's satisfaction during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
timeFrame: within 24hrs after procedure
measure: A comparison of gastric motility, easiness for procedure, operator's satisfaction during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
timeFrame: right after the drugs had administered
Locations:
city: Seoul
country: Korea, Republic of
facility: Anesthesiology & Pain Medicine, Yonsei university college of medicine
Study officials:
References:
citation: Kim N, Yoo YC, Lee SK, Kim H, Ju HM, Min KT. Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection. World J Gastroenterol. 2015 Mar 28;21(12):3671-8. doi: 10.3748/wjg.v21.i12.3671.
Clinical trial NCT00211913: StaphVAX in Cardiovascular Surgery Patients
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Undergoing Cardiovascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Staphylococcal Infections
Cardiovascular Diseases
Cardiovascular Surgical Procedures
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: S. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and during the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for cardiovascular surgery.


Eligibility criteria: Inclusion Criteria:

* Candidate for cardiovascular surgery
* Expected to comply with protocol
* Negative pregnancy test where appropriate
* Written informed consent

Exclusion Criteria:

* Known S. aureus infection in past 3 months
* Known infection in the past 2 weeks
* Known HIV infection
* Pregnancy or breast-feeding
* Immunomodulatory drugs
* Malignancy or treatment for malignancy within the past six months, other than basal cell, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or early stage prostate cancer
* investigational drugs, vaccines or products in the past 30 days
* Hypersensitivity to components of StaphVAX

Primary outcomes:
measure: Serotype-specific antibody concentrations
timeFrame: 6 weeks after the vaccine dose
Secondary outcomes:
measure: Serotype-specific antibody concentrations
timeFrame: at other time points 7-180 days after the vaccine dose.
measure: adverse events
timeFrame: 0-180 days after vaccine dose
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Preston Holley, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00448513: Effects of Tea Catechin Extracts on Oxidative Damage
Official title: Effects of Tea Catechin Extracts on the Frequency Changes of Micronuclei in Peripheral Lymphocytes in Late Middle Aged Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: catechin
oxidative stress
chromosome damage
aged
Lead sponsor: University of Shizuoka
Sponsor class: OTHER
First posted: 2007-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to clarify the effects of tea catechin extracts on the frequency changes of micronuclei in peripheral lymphocytes compared with other oxidative stress markers in late middle aged healthy volunteers

Detailed description: Experimental studies have revealed that tea catechin extracts induce preventive effects on oxidative stress, but there have been few clinical trials conducted to verify the effects. Also, there have been few clinical markers indicating oxidative damage, and therefore, more accurate and reliable markers have been expected. The study is designed for evaluating the effects of tea catechin extracts on the frequency changes of micronuclei in peripheral lymphocytes as the indicator of oxidative damage, compared with other oxidative stress markers in late middle aged healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* aged 40 to 65 years old
* healthy volunteers
* obtained written informed concent before participation

Exclusion Criteria:

* participant who is not able to refrain from drinking tea for 2 weeks during the study
* participant taking supplements or herbal products including folate, vitamin B, C, E, coenzyme Q10, calcium, for 2 weeks before the study
* participant taking supplements or herbal products including folate, vitamin E for 3 months before the study
* participant possessing tea allergy

Primary outcomes:
measure: the frequency changes of micronuclei in peripheral lymphocytes
timeFrame: After seven days untervention
Secondary outcomes:
measure: the change of markers of oxidative damage, as measured by 8-hydroxyguanosine (8-OHdG), vitamin C, folate, homocysteine
timeFrame: After seven days intervention
Other outcomes:
Locations:
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital
Study officials:
affiliation: University of Shizuoka
name: Hiroshi Yamada, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03595813: Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy
Official title: Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy-IMMUNO-SUP-IPC 2017-002
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer Metastatic
Locally Advanced Malignant Neoplasm
Non Hodgkin Lymphoma
Urologic Neoplasms
Keywords: Immune check point blockade
biomarkers
immunomonitoring
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Cancer Research Center of Marseille
First posted: 2018-07-23
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The development of Immune Checkpoint Blockade (ICB) is a revolution in medical oncology as ICB have changed the standard treatments of several metastatic tumor types. However, the response rate to ICB is low, and the biological bases for this response heterogeneity are poorly understood.

In the frame of Immunosup study, we will collect blood (at baseline, post infusion of ICB n°2/4/8 and at progression) and tumor samples (optional: at baseline and progression) from patients with locally advanced or metastatic cancer, treated with ICB, in order to determine if the dynamics of immunosuppressive actors (MDSC, TReg, Immunosuppressive cytokines) predicts response to these immunotherapies.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Diagnosis of locally advanced or metastatic solid tumor or lymphoma treated with Immune check blockade
* Signed informed consent
* Affiliated to(or beneficiary of) the French Social Security

Exclusion Criteria:

* Pregnant or breastfeeding woman or woman who does not apply effective contraception
* Emergency
* Vulnerable person or unable to provide informed consent
* Emergency
* Person unable to comply with required study follow up
* Contraindication to the study procedure

Primary outcomes:
measure: Evaluation of Plasma immunosuppressive actors in patients treated with a Checkpoint inhibitor
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du-Rhône
Study officials:
References:
Clinical trial NCT00991913: Risk Factors of Recovery Room Delirium After Elective Non-cardiovascular Surgery
Official title: Risk Factors of Recovery Room Delirium After Elective Non-cardiovascular Surgery in Post-anaesthesia Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Delirium
Postoperative
Non-cardiovascular surgery
Post-anaesthesia care unit
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18yr, who were admitted to the PACU after elective surgery under general anaesthesia during regular working hours (9:00Am to 5:00Pm)

Brief summary: Despite recent advances in postoperative delirium research, the proportion of patients with postoperative delirium is still high ranging between 20-80%. Although postoperative delirium is a frequent complication and is associated with the need for more inpatient hospital care and longer length of hospital stay, little is known about risk factors for recovery room delirium (RRD) occurred in postanaesthesia care unit. The aim of the study was to determine pre- and intraoperative risk factors for the development of RRD among patients undergoing non cardiovascular surgery.

Detailed description: Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to CAM-ICU criteria. Pre-, intra-, and postoperative data of patients undergoing elective non cardiovascular surgery were prospectively collected, univariate and multivariate logistic regression were performed to find the risk factors related to postoperative delirium.

Eligibility criteria: Inclusion Criteria:

* elective non-cardiovascular surgery
* general anesthesia

Exclusion Criteria:

* under 18yr of age
* under regional anaesthesia
* refused to sign consent form
* history of substance dependence
* underwent neurosurgery
* history of primary neurologic diseases
* stayed less than 10min in PACU
* received general anaesthesia but recovered in locations outside the recovery room

Primary outcomes:
measure: The incidence of delirium in post anesthesia care unit (PACU) determined by confusion assessment method (CAM) -ICU criteria
timeFrame: at 1 hour after operation
Secondary outcomes:
measure: heart rate in PACU
timeFrame: every 10 mins
measure: Pulse Oximeter Oxygen Saturation (SpO2) in PACU
timeFrame: every 10 mins
measure: Hospital-length of stay
timeFrame: up to 6 months
measure: Total health care fees
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Yuke Tian, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT02896413: The Effects of Perioperative Dexmedetomidine Administration on Immune Suppression and Outcomes in Patients With Uterine Cancer Undergoing Radical Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Surgical stress and anesthesia may cause immunosuppression in immunocompromised cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity. Dexmedetomidine has sympatholytic effect and preserves NK cell function. This study investigate the effect of dexmedetomidine on immune suppression and postoperative outcomes in patients undergoing uterine cancer resection.


Eligibility criteria: Inclusion Criteria:

* patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
* patient scheduled for uterine cancer surgery

Exclusion Criteria:

* ASA physical status Ⅳ
* severe hepatorenal disease
* infection
* metastasis to other organ
* problem with communication

Primary outcomes:
measure: natural killer cell cytotoxicity
timeFrame: 1 minute before surgery
measure: natural killer cell cytotoxicity
timeFrame: postoperative day 1
measure: natural killer cell cytotoxicity
timeFrame: postoperative day 3
measure: natural killer cell cytotoxicity
timeFrame: postoperative day 5
Secondary outcomes:
measure: inflammatory response
timeFrame: 1 minute before surgery
measure: inflammatory response
timeFrame: postoperative day 1
measure: inflammatory response
timeFrame: postoperative day 3
measure: inflammatory response
timeFrame: postoperative day 5
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References: