louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05076929: Assessment of Ultrasonographic Measurement of Inferior Vena Cava Collapsibility Index in Prediction of Hypotension Associated With Tourniquet Release in Total Knee Replacement Surgeries Under Spinal Anesthesia
Official title: Assessment of Ultrasonographic Measurement of Inferior Vena Cava Collapsibility Index in Prediction of Hypotension Associated With Tourniquet Release in Total Knee Replacement Surgeries Under Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Hypovolemia, Cerebrospinal
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Total Knee Replacement Surgeries under Spinal Anesthesia

Brief summary: Administration of intravascular fluids is one of the methods to prevent SA-induced hypotension, but empirical intraoperative volume repletion carries the risk of fluid overload during elective surgery. Over fluid resuscitation is associated with organ dysfunction and higher mortality rate , thus, to avoid ineffective or even harmful intravascular volume expansion, it is important to have tools to predict hypotension and fluid responsiveness.


Eligibility criteria: Inclusion Criteria:

* ASA grade I, II, III
* Age 18 -65 yrs
* Spinal Anesthesia

Exclusion Criteria:

* Patient refusal
* Patient having contraindication of Spinal Anesthesia (infection at the site of injection, spine deformity, coagulation disorders ) .
* Known cardiac, renal, neurological, metabolic, endocrine, psychiatric, respiratory disease.

Primary outcomes:
measure: mean arterial blood pressure
timeFrame: 15 minutes after tourniquet release
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT00199329: Antiemetic Effect of the Addition of Ondansetron to the Morphine Solution in Patient-Controlled Analgesia (PCA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: ondansetron
PCA
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 160
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PCA morphine always introduces nausea and vomiting during the postoperative period. Ondansetron can reduce PONV (postoperative nausea vomiting). We, the researchers at Khon Kaen University, are trying to add ondansetron in PCA morphine. Patients receive a small dose of ondansetron when they request morphine.


Eligibility criteria: Inclusion Criteria:

* Age between 15-60 years old

Exclusion Criteria:

* History of motion sickness, smoking

Primary outcomes:
measure: PONV
timeFrame: 24 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Khon Kaen university, Srinagarind Hospital
state: Khon Kaen
Study officials:
affiliation: lecturer in Khon Kaen University
name: Polpun Boonmak, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00790829: Preemptive Use of the Nicotine Patch for Postoperative Pain Relief After Open Abdominal Surgery
Official title: Preemptive Use of Nicotine Patch for Postoperative Pain Relief in Open Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Pain
Keywords: preemptive
Nicotine Patch
Open Abdominal Surgery
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2008-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The efficacy of a low dose nicotine patch of seven milligrams placed before surgery and its effect on decreasing pain after surgery is the main purpose of the study.

Detailed description: Study patients include nonsmokers aged 18-75 undergoing open abdominal wall surgery under general anesthesia. If the patient smokes, receives a regional anesthetic such as an epidural, or is pregnant, then he/she is excluded from the study. There are two randomized study groups. Group B receives a seven-milligram transdermal patch and Group A receives a placebo patch. Generic seven-milligram nicotine patches or identical placebo patches made from band-aids are glued to a 3x4 inch adhesive pad and placed on the individuals' right upper arm 1 hour before surgery. All patients are given a standardized anesthetic consisting of a narcotic infusion, propofol, a neuromuscular blocking agent, anesthetic gas agent, antinauseant medication and a nonsteroidal.

Patients receive postoperative analgesia for twenty four hours after surgery with a narcotic or an additional nonsteroidal medication. All patients receive intravenous controlled patient controlled analgesia (IVPCA) with morphine sulfate one milligram per ten minutes, forty milligram four hour limit. Patients also receive toradol fifteen milligrams for breakthrough pain. The patch is removed from participants twenty four hours post IVPCA initiation. The following items are assessed every four hours for twenty four hours after post anesthesia care unit discharge: a verbal rating of pain, total IVPCA morphine use, nausea occurrence, vomiting occurrence, and sedation score by the nurse.

Eligibility criteria: Inclusion Criteria:

* Study patients include nonsmokers aged 18-75 undergoing open abdominal wall surgery under general anesthesia.

Exclusion Criteria:

* If the patient smokes, receives a regional anesthetic such as an epidural, or is pregnant, then he/she is excluded from the study.

Primary outcomes:
measure: The efficacy of a low dose nicotine patch of seven milligrams placed before surgery and its effect on decreasing pain after surgery is the main purpose of the study.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook University Hospital
name: Ursula N Landman, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03596229: Major Adverse Cardiac Events After Carotid Endarterectomy
Official title: Incidence of Postoperative Major Adverse Cardiac Events in the Patients Underwent Carotid Endarterectomy: A Single Center Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Stenosis
Carotid Endarterectomy
Adverse Cardiac Events
Keywords: carotid endarterectomy
adverse cardiac events
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The carotid stenotic patents scheduled for carotid endarterectomy

Brief summary: Carotid endarterectomy is the operation for curing the significant carotid artery stenotic patients who are also at high cardiac risk. This retrospective study is to find out the incidence and risk factors related.

Detailed description: The investigator plan to retrospectively investigate 175 carotid endarterectomy patients in Siriraj hospital to find the incidences of major adverse cardiac events, including

* Myocardial infarction is defined as rising of cardiac bio-markers in the setting of myocardial ischemia (Relevant anginal symptoms, ECG changes or Imaging e.g. Echocardiography)2,10
* Significant arrhythmia is defined as symptomatic or causing hemodynamic changes without other explainable causes.
* Heart failure is defined according to Modified Framingham criteria3
* Cardiac death is defined as mortality in association and as a direct result from myocardial infarction, arrhythmia or heart failure

if possible, the investigators will try to find the associate or risk factors for those events.

Eligibility criteria: Inclusion Criteria:

* Every patients undergoing carotid endarterectomy in Siriraj hospital

Exclusion Criteria:

* Patients with other simultaneous surgery with carotid endarterectomy

Primary outcomes:
measure: Incidence of major adverse cardiac events after carotid endarterectomy
timeFrame: 7 days
Secondary outcomes:
measure: associate factors with adverse cardiac event
timeFrame: 7 days
measure: other adverse events
timeFrame: 7 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Aphichat Suphathamwit, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. Mutirangura P et al. J Med Assoc Thai 2016; 99 (7): 785-93. 2. Boulanger M et al. Stroke. 2015 Oct;46(10):2843-8. 3. McKee PA et al. N Engl J Med. 1971 Dec 23;285(26):1441-6. 4.Go C et al. Ann Vasc Surg. 2015 Aug;29(6):1265-71. 5.Steinvil A et al. J Am Coll Cardiol. 2011 Feb 15;57(7):779-83. 6.Hoffmann R et al. Heart. 2005 Nov;91(11):1438-41. 7.Sposato LA et al. Journal of the Neurological Sciences. 2011 Oct 15;309(1-2):5-8. 8.Aboyans V et al. Eur Heart J. 2018 Mar 1;39(9):763-816. 9.Varon J, Marik PE. Vasc Health Risk Manag. 2008 Jun; 4(3): 615-627. 10.Landesberg G et al. Circulation. 2009;119:2936-2944
Clinical trial NCT06456229: Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery
Official title: Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery (PICCS-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Ileus Postoperative
Flatus
Diet, Healthy
Keywords: colorectal cancer
colorectal surgery
nutritional supplementation
probiotics
time to bowel movement
time to flatus
length of stay
complications
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 162
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is pre-existing evidence that probiotics could be useful in the improvement of ileus rates. One metaanalysis of 30 studies demonstrated a reduction in the prevalence of post-operative ileus as determined by time to flatus, time to defecation, as well as postoperative abdominal distension (PMID:37373843). More broadly in gastrointestinal surgery, a meta-analysis of 21 randomised controlled trials similarly affirmed the speedier recovery of gastrointestinal function after surgery when probiotics were administered (PMID: 35231076). In spite of these advantages, the routine use of probiotics perioperatively for colorectal cancer surgery is not performed in Singapore. We therefore seek to perform a trial to investigate whether probiotic administration perioperatively may reduce post operative ileus rates.


Eligibility criteria: Inclusion Criteria:

1. undergoing elective colorectal cancer surgery in which an oncologic resection is planned
2. age between 21 and 99 years at the time of consent
3. willing to consider oral nutritional supplementation
4. on an early recovery after surgery (ERAS) pathway
5. able to provide informed consent

Exclusion Criteria:

1. patients with known contraindications to probiotic use
2. patients undergoing emergency surgery
3. taking any other form of probiotics
4. taking oral antibiotics within 7 days of commencement of study
5. vulnerable patients including pregnant patients, inmates, and those who are cognitively impaired and therefore are not able to provide informed consent.

Primary outcomes:
measure: Time to bowel movement
timeFrame: 0 - 14 days
Secondary outcomes:
measure: Time to flatus
timeFrame: 0 - 14 days
measure: Adverse events
timeFrame: From commencement of the intervention to 30 days after surgery
measure: Infective complications
timeFrame: From date of surgery to 30 days after surgery
measure: Length of hospital stay
timeFrame: 0 - 14 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT05054829: Establishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis
Official title: Establishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Skill Training Group
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This project aims to examine the effectiveness of social skill training group in adults with autism spectrum disorders.


Eligibility criteria: Inclusion Criteria:

* Age from 18 to 45 years
* having relational problems
* having motivation to participate
* good chinese speaking
* having a healthy cargiver join together
* IQ \> 70 (WAIS)
* Autism Spectrum Quotient \> 26

Exclusion Criteria:

* ever had psychosis and neurological diseases
* visual and hiring impairment

Primary outcomes:
measure: Outcome analysis
timeFrame: after intervention 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01358929: A Study of RO6807952 in Patients With Diabetes Mellitus Type 2
Official title: A Randomized, Placebo-Controlled, Sequential, Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MAR701/RO6807952 in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18 to 70 years of age, inclusive
* Diagnosis of type 2 diabetes \>/=3 months and \</=10 years prior to screening
* Fasting plasma glucose \>/=110 mg/dL and \</=240 mg/dL
* Patients on a stable dose of metformin for at least 2 months prior to screening
* Hemoglobin HbA1c \>/=6.5% and \</=10.5%
* Body mass index \>/=25 kg/m2 and \</=42 kg/m2
* Systolic blood pressure \<155 mmHg and diastolic blood pressure \<95 mmHg

Exclusion Criteria:

* Patients with type 1 diabetes
* History of significant renal and hepatic diseases
* History of metabolic acidosis and diabetic gastroparesis
* History of pancreatitis
* History of coagulation disorders or unexplained excessive bleeding
* History of clinically significant cardiovascular disease or severe symptomatic hypoglycemia within 6 months of screening

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 8 weeks
Secondary outcomes:
measure: Blood concentrations of RO6807952
timeFrame: 8 weeks
measure: Effect of RO6807952 on Hemoglobin HbA1c level
timeFrame: 8 weeks
measure: Effect of RO6807952 on glucose level
timeFrame: 8 weeks
measure: Change in meal tolerance test
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
city: Cincinnati
country: United States
state: Ohio
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02807129: Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer
Official title: Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 296
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to evaluate frailty in patients aged ≥ 65 years with cancer. The elderly population is very heterogeneous, it is necessary to evaluate these elderly patients before treatment to assess the risk-benefit balance. To date, this assessment relies on subjective clinical methods often not optimal, and slow to implement. An innovative method of evaluation could be the determination of elastin peptides. Indeed, the rate of these peptides, which are linked to serious conditions associated with age, rising inexorably with age and dose could help determine more objectively the type of treatment to offer older patients.

Expected results : This study will allow better identification of the group of frail elderly through more relevant biological marker that clinical assessment, often subjective and not available within a period compatible with the treatment of newly diagnosed cancer. This biological assessment will also enable optimal management of elderly patients in particular by allowing the geriatrician better efficiency.


Eligibility criteria: Inclusion Criteria:

* 65 years or older
* diagnosis of cancer
* affiliation to a social security scheme
* Signed informed consent for the study and for the collection of biological samples

Exclusion Criteria:

* Patient protected by law (guardianship, trusteeship)

Primary outcomes:
measure: elastin peptides quantification
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT01903629: Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy
Official title: A Double-center Self-controlled Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy for Gastric Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastric Symptoms
Indicated for Upper GI Endoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Second Military Medical University
name: Wuhan Union Hospital, China
First posted: 2013-07-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot be used for the large gastric cavity.This blinded prospective study investigates the accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients with gastric symptoms and indicated for Upper GI endoscopy
* Age of 18 years to 70 years

Exclusion Criteria:

* Patients with impaired bowel movement from ileus or organic digestive diseases
* Patients with known large and obstructing tumors of the upper GI tract
* Patients after upper GI surgery or abdominal surgery altering GI anatomy
* Patients under full anticoagulation
* Patient in poor general condition
* Patients using equipment that may be affected by radio transmission
* Patients using equipment that may be affected by magnetic field
* Pregnancy or suspected pregnancy

Primary outcomes:
measure: Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions
timeFrame: 2 days
Secondary outcomes:
measure: Examination times of capsule and standard gastroscopy
timeFrame: 1 hour
measure: Patient acceptance of capsule gastroscopy and standard gastroscopy
timeFrame: 3 days
measure: Adverse events of both procedures
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
Study officials:
References:
citation: Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.
citation: Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031.
citation: Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.
Clinical trial NCT00289029: A Study of Two Iodinated Contrast Agents in Renally Impaired Patients Undergoing Cardiac Angiography
Official title: Visipaque and Isovue in Cardiac Angiography in Renally Impaired Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: CIN
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2006-02-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with moderate to severe renal insufficiency undergoing cardiac angiography. Serum creatinine will be measured before and up to 48-72 hours after the administration of the contrast agent to evaluate renal function.


Eligibility criteria: Inclusion Criteria:

* Referred for cardiac angiography; with a documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2

Exclusion Criteria:

* Unstable renal function; concurrent administration of nephrotoxic drugs, undergoing dialysis

Primary outcomes:
measure: Increase in SCr at 48-72 hours post dose
Secondary outcomes:
measure: Decrease in eGFR at 48-72 hours post dose; occurrence of adverse events; effect on heart rate
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostics, Inc
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Marie Morris
role: STUDY_DIRECTOR
References: