louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00852046: Adjunct Dexmedetomidine (Precedex®) Therapy Impact on Sedative and Analgesic Requirement
Official title: Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Sedation
Analgesia
Keywords: Mechanical ventilation
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2009-02-26
Enrollment: 0
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: Assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.

Detailed description: Patients identified by selection criteria within 48 hours of intubation will be randomly assigned to one of three study arms: dexmedetomidine 0.2 mcg/kg/hr, dexmedetomidine 0.6 mcg/kg/hr, or placebo. If not already on, patients will be converted to propofol and fentanyl for sedation and analgesia, which will be titrated to a goal SAS score of 3-4.

Patients will be monitored, assessed, and evaluated by all regular policies and procedures of the institution. Extubation will be at the discretion of the physicians and medical team caring for the patient. If the patient is still intubated at five days study drug will then be stopped and further use of dexmedetomidine will be at the discretion of the physicians.

Primary objective will assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.

Secondary objectives include total ventilation time, ICU length of stay, hospital length of stay, patient outcomes/mortality, and total pharmacy expenditures.

Eligibility criteria: Inclusion Criteria:

* surgical, medical, or trauma patients requiring sedation for mechanical ventilation
* age 18-80
* Anticipated ventilation time of \> 24 hrs
* Reasonable chance of recovery

Exclusion Criteria:

* Severe COPD
* Chronic immunosuppression (equivalent to prednisone 7.5 mg daily or higher)
* Heart block
* Bradycardia
* Significant head injury
* Goal SAS score of 1-2
* Severe hepatic impairment
* Hypertriglyceridemia
* Allergy to dexmedetomidine, fentanyl, propofol or eggs

Primary outcomes:
measure: Total daily dose of fentanyl and propofol
timeFrame: Daily
Secondary outcomes:
measure: Total ventilation time
timeFrame: Study ended
measure: ICU length of stay
timeFrame: Study ended.
measure: Hospital length of stay
timeFrame: Study ended
measure: Patient outcomes/mortality
timeFrame: Study ended.
measure: Total pharmacy expenditures
timeFrame: Study ended.
Other outcomes:
Locations:
Study officials:
affiliation: Avera McKennan Hospital
name: John A Kappes, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01473446: Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients
Official title: Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients. A Randomized, Assessor-blinded Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Complications
Keywords: Goal directed fluid therapy
perioperative fluid therapy
LiDCOrapid
Postoperative outcome
Open abdominal surgery
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 30
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: Is goal directed fluid therapy reducing postoperative complications in comparison to traditional fluid therapy for gastro surgical ASA III/IV patients?

The investigators compare two groups of patients: one group receives goal directed fluid therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the "traditional" fluids, ie the current regime.


Eligibility criteria: Inclusion Criteria:

* Adult ASA class III \& IV (high risk) patients
* \>18 years
* scheduled for gastrointestinal surgery involving laparotomy
* Both elective and emergency cases

Exclusion Criteria:

* Atrial fibrillation
* Mental impairment, unable to give informed consent
* Severe aortic or mitral stenosis
* Type of surgery: Liver surgery, transthoracic oesophagectomy

Primary outcomes:
measure: Postoperative complications
timeFrame: 5 days after surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 3 month after surgery
measure: Complications until discharge and readmission within 30 days
timeFrame: 3 month after surgery
measure: Mortality within 30 days and 3-month after surgery
timeFrame: 3 month after surgery
measure: Renal function
timeFrame: 5 days after surgery
measure: Vasoactive agents need
timeFrame: 3 month after surgery
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital, Department of Anesthesia and Intensive Care
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Stavanger
country: Norway
facility: Stavanger Universityhospital, Division for medical service, anesthesia and intensive care
Study officials:
affiliation: Helse Bergen HF, Norway
name: Ib Jammer, MD
role: STUDY_CHAIR
References:
citation: Jammer I, Tuovila M, Ulvik A. Stroke volume variation to guide fluid therapy: is it suitable for high-risk surgical patients? A terminated randomized controlled trial. Perioper Med (Lond). 2015 Jul 22;4:6. doi: 10.1186/s13741-015-0016-x. eCollection 2015.
Clinical trial NCT01903746: Epidemiology of Septic Shock in Medical or Polyvalent ICU in the North-East Region of France
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Severe Sepsis
Persistent Hypotension
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 1495
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in septic shock

Brief summary: The epidemiology of this study aims and outcome of patients with septic shock in the intensive care unit (or versatile) of the North-East region in france as well as the modalities of care.


Eligibility criteria: Inclusion Criteria:

* Patients in septic shock defined by hypotension that is not reversed by volume resuscitation and requires the use of vasopressors.

Exclusion Criteria:

* None

Primary outcomes:
measure: Sequential Organ Failure Assessment
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: department Medical Intensive Care
name: jean pierre Quenot
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04618146: Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.
Official title: Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine. A Prospective Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Pruritus
Nausea, Postoperative
Vomiting, Postoperative
Keywords: pain
morphine
cesarean section
enhanced recovery
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to see the effect of low dose intrathecal morphine on promting enhanced recovery after cesarean delivery with early ambulation and reduction of hospital stay.

Detailed description: Parturients showing for elective cesarean section will be randomized into 3 groups by a computer generated randomization list. Each randomization slip will be put in a sealed envelope until patient enrollment. Patients will be divided into Group C: control group, given intrathecal bupivacaine 12.5 mg. Group M25: intrathecal bupivacaine 12.5mg + morphine 25 microgram. Group M50: intrathecal bupivacaine 12.5mg + morphine 50 microgram.

Eligibility criteria: Inclusion Criteria:

* Females scheduled for cesarean section
* Age: 16-45 yrs.
* Gestation age \>38 weeks.
* ASA I,II

Exclusion Criteria:

* Refusal to participate.
* Significant cardiac, hepatic or renal dysfunction.
* History of chronic itching problem, or hyperemesis during pregnancy

Primary outcomes:
measure: Pain postoperative
timeFrame: 2 hours postoperatively
measure: Pain postoperative
timeFrame: 4 hours postoperatively
measure: Pain postoperative
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: vomiting
timeFrame: 2 hours postoperative
measure: vomiting
timeFrame: 4 hours postoperative
measure: vomiting
timeFrame: 24 hours postoperative
measure: itching
timeFrame: 2 hours postoperative
measure: itching
timeFrame: 4 hours postoperative
measure: itching
timeFrame: 24 hours postoperative
measure: respiratory depression
timeFrame: 4 hours postoperative
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university
Study officials:
affiliation: Anesthesia and ICU department, Faculty of Medicine, Minia University
name: Sohair A Megalla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04043546: Observational Feasibility Study of Home-based Training With Therabands in PAD-patients
Official title: Observational Feasability Study of Home-based Training With Therabands in PAD-patients - Addressing the Uncertainty of Acceptance, Satisfaction and Usability of a Home-based, Tele-monitored Program Combining Aerobic and Resistance Components in PAD-patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Intermittent Claudication
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients enrolled in the study receive a novel physiotherapy program.
Primary purpose: TREATMENT

Brief summary: The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC.


Eligibility criteria: Inclusion Criteria:

* age ≥ 50 yrs;
* ankle-brachial index (ABI) ≤ 0.9 in one or two legs;
* Fontaine stage II (Rutherford I 1-3) of PAD (new onset or conservatively treated);
* body mass index \<35 kg/m 2 ;
* resting systolic blood pressure (BP) \<160 mmHg and diastolic BP \<105 mmHg;
* ability to walk at least 2 min at 2.0 mph;
* ability to undertake an incremental treadmill test;
* decrease of at least 15% in ABI after a maximal treadmill test;
* not currently engaging in any regular exercise program.

Exclusion Criteria:

* exercise induced signs of myocardial ischemia or complex ventricular arrhythmias;
* no access to laptop or internet;
* no medical clearance for exercise

Primary outcomes:
measure: user satisfaction
timeFrame: 4 weeks
measure: walking distance
timeFrame: 4 weeks
Secondary outcomes:
measure: Physical activity
timeFrame: 2 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References:
citation: Cornelis N, Buys R, Dewit T, Benoit D, Claes J, Fourneau I, Cornelissen V. Satisfaction and Acceptability of Telemonitored Home-Based Exercise in Patients With Intermittent Claudication: Pragmatic Observational Pilot Study. JMIR Rehabil Assist Technol. 2021 Mar 22;8(1):e18739. doi: 10.2196/18739.
Clinical trial NCT01976546: Intubation With McGrath Video Laryngoscope and Boedeker Intubation Foreceps in a Population of Patients With Predictors of Difficult Airway
Official title: Intubation With McGrath Video Laryngoscope and Boedeker Intubation Foreceps in a Population of Patients With Predictors of Difficult Airway, an Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With One or More Predictors of Difficult Airway
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 25
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: Patients with one or more predictors of difficult airway

Brief summary: Tracheal intubation with videolaryngoscopes have been widely studied, and is now often used in the management of difficult airways.

Videolaryngoscopes with angulated blades can improve laryngeal view, however this does not always match with a higher intubation succes. To adress this matter the aim of this study is gathering experience with intubation with mcgrath videolaryngoscope and a blade-shape intubation foreceps (Boedeker intubation foreceps, Karl Storz, Germany).

The hypothesis is that intubation with this combination is easy and can be a good alternative when using the McGrath videolaryngoscope in patients with predictors of difficult airway.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective surgery
* age over 18 or more
* planned intubation with mcgrath videolaryngoscope
* informed conscent obtained
* patients are
* patients shall be able to read and understand Danish

Exclusion Criteria:

* Patients planned to awake intubation
* stridor
* hypoxia defined by saturation under 90% without oxygen supply
* patients with oxygentreatment at home
* patients that need a wired tube
* patients that need a preshaped tube
* patients that need crash induction
* use of gastric tube

Primary outcomes:
measure: Time to intubation
timeFrame: within one day
Secondary outcomes:
measure: Sore throat
timeFrame: within 2 days
measure: succesful intubation
timeFrame: within one day
measure: Damage on teeth
timeFrame: 2 days
measure: Intubation difficulty
timeFrame: within one day
measure: Intubation conditions
timeFrame: within one day
measure: Intubation attempts
timeFrame: within one day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Anaesthesia, Centre of Head and Orthopedics 4231, Rigshospitalet
Study officials:
affiliation: Dept. of anaesthesia, centre of head and orthopedics, Rigshospitalet, Denmark
name: Camilla Strøm, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04956146: Fruquintinib Combined With Sintilimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer
Official title: A Single Arm,Open-label, Study of Fruquintinib Combined With Sintilimab and Chemotherapy in Patients With Unresectable or Metastatic Advanced Wild-type Genotype Non-squamous Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 46
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: A phase II study to assess the efficacy and safety of Fruquintinib Combined With Sintilimab and Chemotherapy as a first-line treatment in patients with unresectable or metastatic advanced Wild-type Genotype non-squamous Non-small Cell Lung Cancer.


Eligibility criteria: Inclusion Criteria:

1. Voluntary provision of informed consent.
2. Males or females aged 18-75.
3. Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ).
4. Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, gene mutation)
5. At least one lesion can be measured by imaging.
6. Have not received systemic treatment in the past.
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
8. Life expectancy ≥ 12 weeks.
9. Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.

Exclusion Criteria:

1. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
2. Diagnosed with other malignant diseases other than NSCLC within 5 years.
3. Have participated in other interventional clinical research treatments now or within 4 weeks.
4. Have previously received multi-targeted kinase inhibitors therapy.
5. Have active autoimmune diseases requiring systemic treatment within 2 years.
6. Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks.
7. Clinically uncontrollable pleural effusion/abdominal effusion.
8. Vaccinated vaccines or attenuated vaccines within 4 weeks before the group;
9. Pregnant or breastfeeding females.
10. Other serious hazards to the safety of patients.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: up to 24 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to 24 months
measure: Disease control rate (DCR)
timeFrame: up to 24 months
measure: Overall Survival（OS）
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT04121546: Collaborative Care for Opioid Dependence And Pain Pilot Study
Official title: Collaborative Care for Opioid Dependence And Pain Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid Dependence
Chronic Pain
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-10-10
Enrollment: 6
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: This pilot study evaluates a collaborative care program to assist with opioid tapering in patients with chronic pain. Patients will be randomized to receive the intervention or usual care.


Eligibility criteria: Inclusion Criteria:

* Chronic pain for at least 6 months
* Receiving daily opioid treatment

Exclusion Criteria:

* Not speaking English
* Significant psychiatric impairment including severe cognitive impairment, suicidality, schizophrenia, or bipolar disorder
* Known life expectancy of less than 6 months

Primary outcomes:
measure: Opioid Dose Change
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in PROMIS Pain Interference
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Michael A Bushey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00555269: Membrane Blue Versus Infracyanine Green
Official title: Comparison of Macular Function and Visual Fields After Membrane Blue or Infracyanine Green Staining in Vitreoretinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Pucker
Macular Hole
Keywords: Macular pucker
Macular hole
Membrane Blue
Infracyanine Green
Peripheral Visual Field
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
First posted: 2007-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Study population: Patients with a macular pucker or a macular hole, without any other retinal disease

Brief summary: To compare possible toxicities of membrane blue and infracyanine green in vivo by macular function and peripheral visual field.


Eligibility criteria: Inclusion Criteria:

* Macular pucker or macular hole

Exclusion Criteria:

* Any other retinal disease

Primary outcomes:
measure: Visual acuity, macular thickness and peripheral visual field
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
name: Katharina E Schmid-Kubista, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmid-Kubista KE, Lamar PD, Schenk A, Stolba U, Binder S. Comparison of macular function and visual fields after membrane blue or infracyanine green staining in vitreoretinal surgery. Graefes Arch Clin Exp Ophthalmol. 2010 Mar;248(3):381-8. doi: 10.1007/s00417-009-1213-4. Epub 2009 Oct 13.
Clinical trial NCT06916169: A Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042
Official title: An Open-label, Randomized, Fasting, Single, Group 2, Stage 2, Cross-over Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the pharmacokinetic characteristics of AG2304 in healthy subjects.

Detailed description: To evaluate the pharmacokinetic characteristics and safety profiles of AG2304 compared with coadministration AG23041 and AG23042 after a single oral dose administration in healthy Korean subjects under fasting conditions.

Eligibility criteria: Inclusion Criteria:

* A healthy adults aged 19-65 years at the time of screening
* Subjects who are deemed eligible based on the screening tests

Exclusion Criteria:

* Subjects who have taken the investigational drug within 6 months prior to the first dose
* Other exclusions have been applied

Primary outcomes:
measure: AUC
timeFrame: Pharmacokinetic plasma samples collected over a 72-hour period
measure: Cmax
timeFrame: Pharmacokinetic plasma samples collected over a 72-hour period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: