louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06382831: Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery
Official title: Comparing Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery: a Single Centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Anesthesia and Analgesia
Anesthesia, Endotracheal
Keywords: Opioid free anesthesia
Ocular surgery
Ophthalmology surgery
Dexmedetomidine
Post operative nausea and vomiting
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 104
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: Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery


Eligibility criteria: Inclusion Criteria:

* Physical status of ASA 1-2
* Undergo elective ophthalmology surgery under general anesthesia with laryngeal mask insertion
* BMI 17.5-34.9

Exclusion Criteria:

* Allergy to study drugs
* Baseline heart rate \< 70 beat per minute or systolic blood pressure \< 100 mmHg
* Will undergo regional block
* Operation lasting for \> 4 hours or \< 90 minutes
* Consumes opioid routinely prior to operation

Primary outcomes:
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 24 hours
measure: Pain score
timeFrame: 24 hours
measure: Time to laryngeal mask exertion
timeFrame: Intraoperative
measure: Adverse effect
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01245231: Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia
Official title: Stat3 Activation as a Potential Prognostic Marker and Therapeutic Target in Pediatric AML-II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-11-22
Enrollment: 150
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia (AML)

Brief summary: RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is studying prognostic biomarkers in cell samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

Primary

* To determine the percentage of primary acute myeloid leukemia (AML) samples with increased Stat3 signaling pathway activity.
* To evaluate the presence of constitutive Stat3 activation and the sensitivity of Stat3 activation to low- and high-doses of cytokines.
* To evaluate the expression levels of Stat3 protein and the upstream and downstream regulators of Stat3 activation.

Secondary

* To classify samples according to a Stat3 activation pattern and correlate this result with event-free survival (EFS) and overall survival (OS).

OUTLINE: Cryopreserved AML specimens are analyzed for pStat3 and pStat5 levels, response to cytokine levels, and expression level of proteins known to influence stat activity by flow cytometry and western blot assays. Results are also compared with prognostic variables determined in CCG-291 study, including age, race, WBC, and cytogenetic risks.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia (AML)
* Cryopreserved AML specimens

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Correlation of constitutive pStat3 with inducible pStat3
measure: Correlation of pStat3 responses with pStat5 responses, and G-CSF-induced responses with IL-6- induced responses
measure: Correlation of pStat3- and pStat5-induced responses with surface G-CSFR and gp130 expression
measure: Correlation of constitutive pStat3/pStat5 with levels of the negative regulators SOCS3 and SHP1
Secondary outcomes:
measure: Correlation between pStat3/pStat5 and event-free survival and overall survival
Other outcomes:
Locations:
Study officials:
affiliation: Texas Children's Cancer Center
name: Michele S. Redell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04622631: Using 18F- FDG,18F-DOPA and 68Ga-DOTATATE PET/CT in Detection and Evaluation of Response in Patients With NET Undergoing PRRT
Official title: the Use of 18F-FDG, 18F-DOPA and 68Ga-DOTATATE PET/CT in Patients With NETs That Are Potential Candidates for PRRT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuroendocrine Tumors
Keywords: Peptide Receptor Radionuclide treatment
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Sheba Medical Center
First posted: 2020-11-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with neuroendocrine tumor who were found to be eligible for Peptide Receptor Radionuclide Therapy (PRRT)

Brief summary: the investigators will follow up after patients with neuroendocrine tumors who undergo PRRT treatment and evaluate the response for treatment using PET/CT with different tracers

Detailed description: patients with suspected or biopsy proven NET will undergo imaging using a Combination of 18F- FDG , 18F-DOPA and 68Ga-DOTATATE PET/CT before the stat of PRRT . after two cycles of treatment another two PET/CT are done using 18F- FDG and 18F-DOPA and about 6-8 weeks from last treatment the patient will undergo PET/CT using 18F-DOPA .

Eligibility criteria: Inclusion Criteria:

* patient with neuroendocrine tumor
* eligible for PRRT

Exclusion Criteria:

* younger than 18 years old
* pregnancy

Primary outcomes:
measure: Number of participants with good response to Peptide Receptor Radionuclide Therapy (PRRT)
timeFrame: 7 months
measure: Number of participants with no response to Peptide Receptor Radionuclide Therapy (PRRT) treatment
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT02410031: Risk Minimisation Study for Diane-35 and Its Generics
Official title: Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: RTI Health Solutions
First posted: 2015-04-07
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians eligible to participate who have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics

Brief summary: The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist.

Specifically, the following objectives will be addressed:

* Investigate whether physicians have received any educational material related to Diane-35 or its generics
* Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card
* Assess physicians' knowledge and understanding of key safety information pertaining to the following areas:
* Contraindications relevant to thromboembolism
* Risk factors for thromboembolism
* Signs and symptoms of thromboembolism


Eligibility criteria: Inclusion Criteria:

-Physicians eligible to participate will have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics

Primary outcomes:
measure: The knowledge of the physician concerning Diane-35
timeFrame: Day1
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Austria
city: Many Locations
country: Czech Republic
city: Many Locations
country: France
city: Many Locations
country: Netherlands
city: Many Locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00743431: Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)
Official title: Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Neoplasms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 224
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with advanced ovarian cancer with:

previous platin/taxane therapy and

documented measurable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.

Brief summary: The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.

Detailed description: This observational program is aimed at gaining tolerability and safety data with the routine use of Caelyx in its labelled indication in ovarian cancer, focusing on infusion reaction and PPE.

Data will be raised about the premedication routinely used for the prevention of side effects caused by Caelyx. Premedications for infusion reactions include corticosteroids, serotonin 3 (5HT3) antagonists, histamine 1 (H1) blockers, and histamine 2 (H2) blockers. Premedications for PPE include oral dexamethasone and vitamin B6.

The management of infusion reactions and PPE will be recorded. A detailed record of the medical history may reveal patient groups at a higher risk of experiencing these side effects.

Eligibility criteria: Inclusion Criteria:

* Women with advanced ovarian cancer with:

  * previous platin/taxane therapy and documented measureable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.

Exclusion Criteria:

* Patients that are not treated according to the Austrian Summary of Product Characteristics (SPC)

Primary outcomes:
measure: Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)
timeFrame: The observational program was conducted over a period of 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Steppan I, Reimer D, Sevelda U, Ulmer H, Marth C, Zeimet AG. Treatment of recurrent platinum-resistant ovarian cancer with pegylated liposomal doxorubicin--an evaluation of the therapeutic index with special emphasis on cardiac toxicity. Chemotherapy. 2009;55(6):391-8. doi: 10.1159/000262452. Epub 2009 Nov 30.
Clinical trial NCT00851331: Genetic Basis of Idiopathic Focal Epilepsies With Cognitif Deficits
Official title: Genetic Basis of Idiopathic Focal Epilepsies With Cognitif Deficits
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: Benign childhood epilepsy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2009-02-25
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Epilepsy is a frequent neurological disease in childhood, characterized by recurrent seizures and sometimes with major effects on social, behavioral and cognitive development. Childhood focal epilepsies particularly are age-related diseases mainly occurring during developmental critical period. A complex interplay between brain development and maturation processes and susceptibility genes may contribute to the development of various childhood epileptic syndromes associated with language and cognitive deficits. Indeed, the Landau-Kleffner syndrome (LKS), the continuous spike-and-waves during sleep syndrome (CSWS), and the benign childhood epilepsy with centrotemporal spikes (BCECTS) or benign rolandic epilepsy, are different syndromes that are considered as part of a single continuous spectrum of disorders. While genetic component in those three syndromes remains elusive, novel and high throughput genome analyzes could bring interesting insights into the possible genetic defects and pathophysiological mechanisms underlying and linking the various disorders associating epilepsy with speech and cognitive impairments.


Eligibility criteria: Inclusion Criteria:

* iodiopathic focal epilepsy with cognitif deficit

Exclusion Criteria:

* medical history of status epilepticus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant - Hospices Civils de Lyon, Service Epilepsie, Sommeil et Exploration fonctionnelle neurologique pédiatrique
state: 69500
city: Reims
country: France
facility: American Memorial Hospital, CHU de Reims, Unité de Neurologie Pédiatrique - Service Pédiatrie A
city: Strasbourg
country: France
facility: Clinique neurologique, Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Hôpital de Hautepierre, Service de pédiatrie 1
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Edouard HIRSCH, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03273231: The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection
Official title: The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Systemic inflammation caused by surgery may aggravate immunosuppression in immunocompromised cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity. ketamine, a N-methyl-D-asparate receptor antangonist, has anti-inflammatory activity and opioid-sparing effect. This study investigate the effect of intraopertaive ketamine administration on immune function in patients undergoing laparoscopic colorectal cancer resection.


Eligibility criteria: Inclusion Criteria:

* patient between 20 and 80 of age with ASA physical status Ⅰ-Ⅲ
* patient scheduled for laparoscopic colorectal cancer resection

Exclusion Criteria:

* ASA physical status Ⅳ
* severe hepatorenal disease
* heart failure
* infection
* increased intracranial pressure, seizure
* preoperative chemotherapy
* immune or endocrine disease
* metastasis to other organ
* problem with communication
* pregnancy
* body mass index \> 35 kg/m2

Primary outcomes:
measure: natural killer cell cytotoxicity
timeFrame: Baseline
measure: natural killer cell cytotoxicity
timeFrame: 1 hour after surgery
measure: natural killer cell cytotoxicity
timeFrame: postoperative day 1
measure: natural killer cell cytotoxicity
timeFrame: postoperative day 2
Secondary outcomes:
measure: proinflammatory cytokine
timeFrame: Baseline
measure: proinflammatory cytokine
timeFrame: 1 hour after surgery
measure: proinflammatory cytokine
timeFrame: postoperative day 1
measure: proinflammatory cytokine
timeFrame: postoperative day 2
measure: recurrence
timeFrame: 1 year after surgery
measure: metastasis
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Cho JS, Kim NY, Shim JK, Jun JH, Lee S, Kwak YL. The immunomodulatory effect of ketamine in colorectal cancer surgery: a randomized-controlled trial. Can J Anaesth. 2021 May;68(5):683-692. doi: 10.1007/s12630-021-01925-3. Epub 2021 Feb 2.
Clinical trial NCT01947231: GPR vs Manual PT for Chronic Neck Pain
Official title: Randomized Controlled Trial of Global Postural Re-education vs. Standard Manual Physical Therapy for Non-specific Chronic Neck Pain With Cross-over
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonspecific Chronic Neck Pain
Keywords: neck pain
chronic
Global Postural Re-education
manual therapy
physical therapy
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Effective treatment for nonspecific chronic neck pain is a clinical challenge. Patients will be randomized into two groups to compare the outcomes of Global Postural Re-education (GPR) with standard manual physical therapy on with respect to pain, function, kinesiophobia, range of motion, perceived effect, and satisfaction.

Detailed description: These study will use two groups: one to receive GPR which is a systematic method of addressing musculoskeletal pain and related functional deficits and the other to receive "usual care" manual PT which will be individualized to the patient's condition. Usual care will include techniques commonly used in clinical practice selected by the physical therapist after initial examination. After nine weeks of treatment, baseline measures will be re-evaluated. After conclusion of the first phase of the study, patients who were randomized to the "usual care" group will cross-over and receive GPR.

Eligibility criteria: Inclusion Criteria:

-nonspecific neck pain lasting at least 3 months

Exclusion Criteria:

* acute or subacute cervical pain
* specific or known cause of pain
* central or peripheral neurological signs
* systemic pathology
* rheumatologic pathology
* neuromuscular pathology
* cognitive impairment
* surgical intervention in the last 6 months prior to study
* physical therapy treatment in the last 6 months prior to study

Primary outcomes:
measure: Pain
timeFrame: 9 weeks after start of intervention
measure: Cervical Functional Limitations
timeFrame: 9 weeks after start of intervention
Secondary outcomes:
measure: Kinesiophobia
timeFrame: 9 weeks after start of intervention
measure: Cervical Range of Motion
timeFrame: 9 weeks after start of intervention
measure: Self-reported Global Effect of the Intervention
timeFrame: 9 weeks after start of intervention
measure: Patient Satisfaction
timeFrame: 9 weeks after start of intervention
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi
state: Emiglia-Romagna
Study officials:
affiliation: University of Bologna
name: Paolo Pillastrini
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05530473: Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts
Official title: Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Lens Rotation
Capsular Tension Ring
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2022-09-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study included cataract patients who underwent intraocular lens (IOL) implantation with or without capsular tension ring (CTR), which aimed to evaluate the contribution of the use of CTR in clinical visual outcomes and rotational stability of IOL after cataract surgery.


Eligibility criteria: Inclusion Criteria:

-cataract

Exclusion Criteria:

* preexisting corneal pathology
* small pupil
* glaucoma
* zonular dehiscence
* a history of ocular trauma or surgery
* uveitis
* intraoperative complications

Primary outcomes:
measure: IOL rotation degree at one hour
timeFrame: one hour
measure: IOL rotation degree at 1 day
timeFrame: one day
measure: IOL rotation degree at 3 days
timeFrame: three days
measure: IOL rotation degree at 1 week
timeFrame: one week
measure: IOL rotation degree at 2 weeks
timeFrame: two weeks
measure: IOL rotation degree at 1 month
timeFrame: one month
measure: IOL rotation degree at 3 months
timeFrame: three months
measure: IOL rotation degree at 6 months
timeFrame: three months
measure: IOL rotation degree at 12 months
timeFrame: three months
measure: Residual astigmatism (RAS) at two weeks
timeFrame: two weeks
measure: Residual astigmatism (RAS) at one month
timeFrame: one month
Secondary outcomes:
measure: visual acuity (VA) at 1 day
timeFrame: two weeks
measure: visual acuity (VA) at 3 days
timeFrame: two weeks
measure: visual acuity (VA) at 1 weeks
timeFrame: two weeks
measure: visual acuity (VA) at 2 weeks
timeFrame: two weeks
measure: visual acuity (VA) at 1 month
timeFrame: one month
measure: visual acuity (VA) at 3 months
timeFrame: three months
measure: visual acuity (VA) at 6 months
timeFrame: six months
measure: visual acuity (VA) at 12 months
timeFrame: twelve months
measure: IOL tilt at 1 day
timeFrame: one day
measure: IOL tilt at 3 days
timeFrame: three days
measure: IOL tilt at 1 week
timeFrame: one week
measure: IOL tilt at 2 weeks
timeFrame: two weeks
measure: IOL tilt at 1 month
timeFrame: one month
measure: IOL tilt at 3 months
timeFrame: three months
measure: IOL tilt at 6 months
timeFrame: six months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital
name: Jin Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: