louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03024957: Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity
Official title: Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity in Patients Undergoing Major Abdominal Cancer Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Immune System Suppression
Keywords: morphine
dexmedetomidine
immune system
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this work aims to investigate the effect of intrathecal administration of Morphine, Dexmedetomidine or both in combination on cellular immunity and cytokine production in patients undergoing major abdominal cancer surgeries.

Detailed description: Intrathecal (IT) adjuvants prolong the duration of spinal anesthesia and postoperative analgesia thereby reducing the requirement of postoperative supplemental analgesics. The incorporation of adjuvants also lowers the overall dose of local anesthetic and hence associated side effects. Morphine has been used widely to alleviate various types of pain and to supplement general anesthesia. On the other hand, morphine has been reported to possess some immunosuppressive effects. Postoperative immunity is also important in conjunction with defence against malignant tumour. Dexmedetomidine is a highly selective α2 agonist with analgesia, sedation, anxiolysis, and sympatholysis as its useful pharmacological actions. The extended analgesic efficacy of IT dexmedetomidine (ITD) in the postoperative period has been shown in a few clinical studies. In addition, current insights have identified that dexmedetomidine has a capacity in inhibiting the overproduction of a variety of inflammatory molecules including TNF-α, IL-1β, and IL-6 in several acute inflammatory animal models.

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients scheduled for major abdominal cancer surgeries

Exclusion Criteria:

* patients with known allergy to the study drugs,
* significant cardiac, respiratory, renal or hepatic disease,
* drug or alcohol abuse,
* psychiatric illness that would interfere with perception and assessment of pain.

Primary outcomes:
measure: Change from the base line in cellular immunity
timeFrame: Baseline , immediate postoperative, 4 hours postoperative and 24 hours postoperative
Secondary outcomes:
measure: Change from baseline in Cytokines
timeFrame: Baseline, immediate postoperative, 4 hours postoperative and 24 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT02303457: CO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved
Official title: Multicenter, Prospective, Randomized and Controlled Clinical Study 0f CO2 Laser and Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Squamous Cell Carcinoma of Glottis
Keywords: CO2 laser surgery
open surgery
multicenter prospective
randomized
controlled clinical studies
T1N0 squamous cell carcinoma of glottis with anterior commissure involved
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2014-12-01
Enrollment: 402
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Open surgery and CO2 laser surgery are both established treatment modalities for T1N0 glottic carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure involved.


Eligibility criteria: Inclusion Criteria:

* T1N0 SCC of glottic carcinoma with anterior commissure involve
* No nodal metastasis and distant metastasis
* All patients must have CT/MR and electronic laryngoscope test before surgery and after surgery
* Expected lifetime\>1 year
* Patients and families agreed to participate in the test and sign the informed consent
* Without cognitive impairment.

Exclusion Criteria:

* With severe cardiac insufficiency Liver and kidney function is not complete systemic infection patients
* Patients with pregnancy and lactation
* Have surgery contraindications

Primary outcomes:
measure: disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: recurrence rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: ye cao, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01147757: Effect of Intraoperative Remifentanil Infusion Rate on Postoperative Tolerance and Analgesic Consumption in Pediatric Laparoscopic Ureteroneocystostomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatrics
Keywords: pediatric patients (ASA physical status I or II) aged between
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic consumption in pediatric laparoscopic ureteroneocystostomy.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients (ASA physical status I and II) aged between 1-5 yrs and scheduled elective laparoscopic ureteroneocystostomy

Exclusion Criteria:

* cardiovascular, renal, liver disease or growth retardation

Primary outcomes:
measure: fentanyl consumption for IV-PCA
timeFrame: 24 h and 48 h after surgery
measure: Postoperative pain score
timeFrame: during 48 h after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
name: Jeong-Yeon Hong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06484257: Comparison Between Myopia Versus Hypermetropia With Progressive Addition Lenses in Computer Users
Official title: Comparison Between Myopia Versus Hypermetropia With Progressive Addition Lenses in Computer Users
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Hypermetropia
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study examines how myopia (nearsightedness) and hyperopia (farsightedness) affect the use of progressive addition lenses (PALs) for computer users. PALs offer a range of vision correction within one lens, ideal for presbyopia (age-related near focusing difficulty). We'll compare visual comfort, eye strain, and user preference for PALs between myopic and hyperopic individuals while focusing on computer screens.

Detailed description: The research will also consider if general-purpose PALs differ from computer-specific PALs in these user groups, and how presbyopia progression might influence PAL effectiveness for each condition. This information can help eye doctors recommend the most suitable PAL design for computer users with myopia or hyperopia.

Eligibility criteria: Inclusion Criteria:

* The age of Participant will be 40 to 55 years
* Participant diagnosed with myopia having -0.50 to -3.00DS and astigmatism up to -0.75DC
* Patient diagnosed with Hypermetropia having +050 to +3.00 DS and Astigmatism up to +0.75DC
* Presbyopia addition will range from +1.00 to +2.50 DS
* Participants who have worked more than 4 hours on the computer screen.
* Participants who will be already progressive users and first-time users.
* Patients with no Ocular disease.

Exclusion Criteria:

* Participants with Pre Presbyopia and above 55 years of age
* Participants with significant ocular disease.
* Participants with uncontrolled diabetes and hypertension
* Participants who will not be willing for PAL,s
* Participants with more than 0.75 astigmatism
* Participants with known allergies and sensitivity.

Primary outcomes:
measure: Visual Acuity
timeFrame: 12 Months
measure: Subjective Visual Comfort
timeFrame: 12 months
measure: Visual Fatigue
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society
state: Punjab
Study officials:
References:
Clinical trial NCT06425757: Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia
Official title: Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypoproteinemia
Pharmacokinetics
Ciprofol
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia

Detailed description: This study was a single-center, interventional clinical study. Patients with different plasma albumin levels were selected before surgery and induced by a single injection of Ciprofol at a depth of 0.3 mg/kg. 2ml of venous blood was collected before and 0.5, 1, 2, 3, 5, 8, 15, 30min, 1h, 2h and 4h after administration. The pharmacokinetics of Ciprofol were studied by measuring the concentration of Ciprofol in blood.

Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe hypoproteinemia (albumin \< 30g/L, protein detection time uniformly within three days before surgery）
* Weight greater than 45kg, BMI20-24
* The ASA rating is Class I or Class II

Exclusion Criteria:

* Severe liver dysfunction
* Severe renal dysfunction
* Patients with ASA grade III and above
* Known allergy to eggs, soy products, opioids and their relief drugs, propofol
* Emergency surgery

Primary outcomes:
measure: Blood concentrations at different time points after a single injection
timeFrame: Before administration, after administration 0.5 minute, 1 minute, 2 minutes, 3 minutes, 5 minutes, 8 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours
Secondary outcomes:
measure: Onset time of ciprofol in patients with hypoproteinemia
timeFrame: Day 1
measure: Effect time of ciprofol in patients with hypoproteinemia
timeFrame: Day 1
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: XIE Kangjie, doctoral
role: STUDY_DIRECTOR
References:
Clinical trial NCT02620657: Evaluate EGFR Mutation Status and Impact Factors in North China
Official title: A Retrospective Study on Real-world EGFR Mutation Testing Practice Status and Impact Factors in Patients With Advanced NSCLC in North China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 2809
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3000 advanced NSCLC patients

Brief summary: Approximately 3000 advanced NSCLC patients, who fulfil the inclusion/exclusion criteria, will be recruited by 30 sites in North China.

Detailed description: Approximately 3000 advanced NSCLC patients will be recruited , and the medical information of recruited patients must be recorded in the hospital electronic system from Jan 1st 2014 to Dec 31st 2014 .The study will focus on the EGFR testing rate in adenocarcinoma patients，so the collecting data for non-adenocarcinoma patients will be controlled in less than 10% for each site.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmed NSCLC;
* Patients were diagnosed with advanced NSCLC from Jan 1st 2014 to Dec 31st 2014;
* Researchers should collect the records of consecutive NSCLC patients in each site.

Exclusion Criteria:

* Any patients without NSCLC diagnosis;
* Any patients which were diagnosed with advanced NSCLC before Jan 1st 2014 or after Dec 31st 2014.

Primary outcomes:
measure: To investigate the proportion of advanced NSCLC patients who performed EGFR mutation test
timeFrame: 2014.01.01-2014.12.31
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jilin Provincial Tumor Hospital
name: CHENG NA Ying, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00716157: Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation
Official title: A Prospective Study to Evaluate the Incidence and Patterns of Nausea and Vomiting in Patients Receiving Combined Chemotherapy and Radiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Head and Neck
Cancer of the Lung
Cancer of the Esophagus
Gastro-esophageal Junction Cancer
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University practice patients with aerodigestive malignancy

Brief summary: Questionnaire study to observe the incidence and pattern or nausea and vomiting in patients receiving combined chemotherapy and radiation. 83% of patients experience radiation therapy-induced vomiting; significant nausea and vomiting could develop with concurrent chemotherapy despite standard anti-nauseous medication prophylaxis.

Detailed description: Questionnaires will be answered daily on a weekly basis during period of radiation and chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Concurrent radiation and chemotherapy treatment
* Aerodigestive malignancy

Exclusion Criteria:

* Other causes of vomiting (i.e.gastrointestinal obstruction...)

Primary outcomes:
measure: Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation
timeFrame: week of treatment
Secondary outcomes:
measure: Assess the impact of nausea and vomiting on the patients' daily functioning
timeFrame: week of treatment
measure: Study the incidence of mucositis and esophagitis
timeFrame: week of treatment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Rita Axelrod, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00972257: 24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination
Official title: Quality of 24-hour Intraocular Pressure Control Obtained With Dorzolamide/Timolol Fixed Combination (DTFC) Compared With the Brimonidine/Timolol Fixed Combination (BTFC) in Subjects With Primary Open-angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: 24-hour IOP control
primary open-angle glaucoma
brimonidine/timolol
dorzolamide/timolol
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2009-09-04
Enrollment: 64
Sex: ALL
Minimum age (years): 29
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The proposed study will compare for the first time the quality of 24-hour IOP control with Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may determine the real efficacy of the two fixed combinations and the design of the proposed study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less than might be anticipated.


Eligibility criteria: Inclusion Criteria:

* Consecutive, newly diagnosed or previously untreated POAG patients
* Patients with typical glaucomatous disc, or visual field damage
* Patient must have IOP (at 10:00 ± 1 hour)greater than 25 mm Hg

Exclusion Criteria:

* Uncontrolled glaucoma
* Distance best corrected Snellen visual acuity worse than 1/10
* Contraindications to brimonidine or dorzolamide and β-blockers
* History of lack of response (\<10% morning IOP reduction) to any medication
* Patient can not understand the instructions and adhere to medications
* Patient is a female of childbearing potential or lactating mother
* Prior surgery, past use of steroids (within 2 months)
* Severe dry eyes and use of contact lenses
* History of non-adherence
* Patients with closed angles

Primary outcomes:
measure: To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma.
timeFrame: 3 months
Secondary outcomes:
measure: Assess fluctuation of 24-hour pressure
timeFrame: 3 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Glaucoma Unit, 1st University Dept of Ophthalmology
Study officials:
affiliation: Head of Glaucoma Unit
name: Anastasios Konstas, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Konstas AG, Quaranta L, Yan DB, Mikropoulos DG, Riva I, Gill NK, Barton K, Haidich AB. Twenty-four hour efficacy with the dorzolamide/timolol-fixed combination compared with the brimonidine/timolol-fixed combination in primary open-angle glaucoma. Eye (Lond). 2012 Jan;26(1):80-7. doi: 10.1038/eye.2011.239. Epub 2011 Sep 30.
Clinical trial NCT03560557: Optimization of PK/PD Target Attainment for Meropenem in Critically Ill Patients With Sepsis
Official title: Optimization of PK/PD Target Attainment for Meropenem in Critically Ill Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Pharmacokinetics
Keywords: Pharmacokinetics
Meropenem
Critical illness
Capillary leak
Augmented renal clearance
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 116
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: Critically ill patients with sepsis and receiving meropenem

Brief summary: WP1.1. PK/PD target attainment: Plasma exposure, Excretion via urine \& ELF exposure; WP1.2. Predictive dosing algorithm; WP1.3. ECMO subset

Detailed description: First, the investigators will document exposure to meropenem in plasma and epithelial lining fluid. Moreover excretion in urine will be documented.

Second, the investigators will try to identify risk factors for not attaining PK/PD target. Based on significant predictors for target non attainment a predictive dosing algorithm will be constructed.

Finally in a small subset of ECMO patients PK exposure will be explored.

Eligibility criteria: Inclusion Criteria:

* Severe sepsis or septic shock
* Admitted to an ICU ward
* Treated with meropenem

Exclusion Criteria:

* eGFR(CKD-EPI) \< 70ml/min/1.73m²
* Renal replacement therapy
* Pregnancy
* DNR code 1-3

Primary outcomes:
measure: Risk factors for target non attainment
timeFrame: on day of sampling
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UZ Leuven
name: Isabel Spriet, PharmD PhD
role: STUDY_DIRECTOR
References:
citation: Gijsen M, Elkayal O, Annaert P, Van Daele R, Meersseman P, Debaveye Y, Wauters J, Dreesen E, Spriet I. Meropenem Target Attainment and Population Pharmacokinetics in Critically Ill Septic Patients with Preserved or Increased Renal Function. Infect Drug Resist. 2022 Jan 8;15:53-62. doi: 10.2147/IDR.S343264. eCollection 2022.
Clinical trial NCT03795857: Antenatal Palliative Care
Official title: Lethal Fetal Abnormality : the Experience of Pregnancy by Parents Who Have Chosen to Carry to Term With Palliative Care.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Death
Fetal Anomaly
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will focus on couples who have been diagnosed with lethal fetal pathology and who have chosen to continue the pregnancy for a birth in palliative care.

The death of the child may have occurred in utero or after birth.

Brief summary: In France, according to current legislation, termination of pregnancy could be performed without any upper gestational age limit, if there is a strong probability that the fetus will be affected by a particularly severe and incurable disease. When there is a lethal fetal diagnosis most of parents wish to terminate their pregnancy. However, and despite some medical resistance a few of them do wish to continue pregnancy. In these situations, palliative care seems to be a good way to prepare to welcome the child and surround him until death.

The aim of the study is to describe parents' experience for a better understanding and a better care.


Eligibility criteria: Inclusion Criteria:

* The woman must be between the ages of 18 and 50 and the adult,
* Participants must have received the information and not have objected to participating in the study,
* the lethal / adverse short-term prognosis of the fetal pathology must have been confirmed by a committee of experts (CPDPN),
* The choice to continue the pregnancy should have been clearly expressed,
* The birth of the child should not be older than 24 months.
* The child's death must be more than 6 months old (or not have occurred)

Exclusion Criteria:

* Non-mastery of the French language,
* Measure of legal protection of one of the members of the couple (guardianship, trusteeship, ...),
* Severe psychiatric or neurological disorders inducing significant cognitive impairment.

Primary outcomes:
measure: Description of the pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis
timeFrame: About 1 hour and 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Équipe de psychopathologie périnatale - Service de psychopathologie du développement - Centre Hospitalier Femme-Mère-Enfant - Hospices Civils de Lyon
city: Lyon
country: France
facility: Service de gynécologie obstétrique - Hôpital de la Croix Rousse
city: Pierre-Bénite
country: France
facility: Service de gynécologie-obstétrique - Centre hospitalier Lyon sud
Study officials:
References: