louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00203346: Research Study Examining Nerve Block for Migraine
Official title: Greater Occipital Nerve (GON) Block for Migraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Migraine and the skin sensitivity that accompanies it can go away in minutes after a nerve block, which is a procedure involving an injection of a small amount of a local anesthetic next to a nerve to the skin, causing an area of skin to become numb. We have also noticed that light sensitivity goes away quickly after a nerve block. We would like to see how quickly this happens and how long the benefit of nerve block lasts. We are interested to see if these effects are due to the injection itself or due to the lidocaine.

A subject may be asked to participate in this study if a subjects physician has planned for a subject to receive an injection of BOTOX® in the area of the Greater Occipital Nerve (a spinal nerve located at the back of the head) as part of a subjects routine preventive treatment for migraine today.


Eligibility criteria: Inclusion Criteria:

* Subjects with episodic or transformed migraine age 18to 80 years old.
* Subjects must have unilateral migraine headache and trigeminal distribution brush allodynia at the time of injection.
* Subjects must be able to consent or assent to the study.

Exclusion Criteria:

* Subjects who in their own or in the investigator's opinion are unable to report the severity of four symptoms (pin sharpness to determine efficacy of nerve block, headache severity, photophobia severity and allodynia severity), every 30 seconds for 5 minutes post injection;
* Subjects with skull defect, or history of injury to the area of the GON.
* Subjects with prior adverse reaction to GON block, lidocaine or marcaine.
* Subjects who are pregnant or lactating

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University, Jefferson Headache Center
name: William B Young, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02662946: Evaluation of Intestinal Vascolarization With Indocianine Green Angiography During Rectal Resection or Left Colectomy
Official title: Evaluation of Intestinal Vascolarization by Intraoperative Angiography With Indocianine Green During Laparoscopi Rectal Resection or Left Colectomy: Predictive Value on Anastomotic Leak.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Disease
Sigmoid Disease
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 208
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: PREVENTION

Brief summary: A randomized controlled multicenter trial on the usefulness of intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients who undergo laparoscopic rectal resection or left colectomy.

Detailed description: Anastomotic leakage after colorectal surgery is a severe complication. One possible cause of anastomotic leakage is insufficient vascular supply. The aim of this study is to evaluate the usefulness of intraoperative assessment of vascular anastomotic perfusion in laparoscopic colorectal surgery using indocyanine green (ICG)-enhanced fluorescence, in order to assess if the information of the ICG angiography could lead to change the site of resection and improving the anastomotic leak rate. Two-hundred and eight patients, undergoing rectal resection or left colectomy, for benign or malignant disease, with high vessels ligation, will be randomized intro 2 arms: ICH angiography (colonic perfusion is intraoperatively assed with ICG angiography and level of resection is selected based on the fluorescence) and Control (resection is performed with subjective judgment). The rate of postoperative leak in the two groups will be recorded.

Eligibility criteria: Inclusion Criteria:

* adult patiens
* laparoscopic rectal resection or left colectomy

Exclusion Criteria:

* rectal amputation
* no anastomosis
* allergy to iodine or indocyanine green

Primary outcomes:
measure: Anastomotic leak rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Scientific Institute
Study officials:
affiliation: San Raffaele Scientific Institute
name: Paola De Nardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Nardi P, Elmore U, Maggi G, Maggiore R, Boni L, Cassinotti E, Fumagalli U, Gardani M, De Pascale S, Parise P, Vignali A, Rosati R. Intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients undergoing laparoscopic colorectal resection: results of a multicenter randomized controlled trial. Surg Endosc. 2020 Jan;34(1):53-60. doi: 10.1007/s00464-019-06730-0. Epub 2019 Mar 21.
Clinical trial NCT06318546: Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section
Official title: Efficacy of Dexmedetomidine As Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post Spinal Shivering in Parturients Undergoing Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post Spinal Shivering
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 130
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators will test the effects of intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine and it's direct effect in decreasing incidence of post spinal shivering in Parturients Undergoing Caesarean section

Detailed description: A.Preoperative settings:

All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery.

B.Intraoperative and postoperative settings:

On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\\kg.

For each group, patients will be put in sitting position, the procedure will be performed under complete aseptic precautions, local anaesthesia will be administered by infiltration of the skin and subcutaneous tissues with 3-5 ml lidocaine 1% at L3-L4 and A 25-G needle will be used.

Both groups will be given 2.2ml {11-12 mg} hyperbaric Bupivacaine hydrochloride 0.5%

Eligibility criteria: Inclusion Criteria:

* • ASA I or ASA II patients Scheduled for CS under spinal anaesthesia.

  * Age 20-35 years.
  * Height ≤165 cm.
  * BMI ≤40.
  * Procedure duration ≤ 90 minutes.

Exclusion Criteria:

* • Patients with known neurologic and psychiatric illness.

  * Contraindications for spinal anaesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia.
  * Spine abnormalities.
  * Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
  * Allergy to any of the drugs used in the study.
  * Toxemia of pregnancy or hypertension with pregnancy.

Primary outcomes:
measure: Post spinal shivering
timeFrame: From injection to 3 hours post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Anesthesia resident Ain Shams University
name: Osama M Ragab, M.B.B.CH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01492946: Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome
Official title: Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome (PreopBIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Status
Keywords: Malnutrition
Post-operative outcome
Phase angle
MUST
Clavien Dindo classification
Bioelectrical impedance analysis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elective surgical patients

Brief summary: The aim of this retrospective observational study is to determine the impact of preoperative nutritional status on postoperative outcome. Elective surgical patients were screened with Bio-Impedance-Analysis, Malnutritional Universal Screening Tool, and other variables for body composition. Outcome parameters were collected by patient chart review.


Eligibility criteria: Inclusion Criteria:

1. Elective surgical intervention
2. Patients must be 18 years or older
3. Ambulation
4. ASA-Score I-IV
5. bioelectrical impedance analysis to determine the phase angle

Exclusion Criteria:

1. Emergency surgery
2. Pregnancy
3. ASA Score V-VI
4. Amputated limbs
5. Pacemaker and defibrillators
6. Cerebrovascular events
7. Tattoos on the electrode locations

Primary outcomes:
measure: Phase-angle
timeFrame: preoperative
Secondary outcomes:
measure: body weight
timeFrame: preoperative
measure: body mass index (BMI)
timeFrame: preoperative
measure: preoperative weight loss
timeFrame: 3 month weight loss before operation
measure: hip/waist ratio
timeFrame: preoperative
measure: Malnutrition Universal Screening Tool (MUST)
timeFrame: preoperative
measure: postoperative complications
timeFrame: postoperative
measure: Length of hospital stay
timeFrame: participants will be followed for the duration of hospital stay
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University,
Study officials:
affiliation: Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University, Berlin, Germany
name: Claudia Spies, MD Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03986346: The Vascularity Changes of Scars With Laser Therapy
Official title: The Vascularity Changes of Scars With Receiving Pulsed Dye Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Scar
Keywords: hypertrophic scar
pulsed dye laser
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: Southwest Hospital, China
First posted: 2019-06-14
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the effects of pulsed dye laser on managing scar vascularity and thickness.

Detailed description: The pulsed dye laser is increasingly used in clinical settings to manage scars and shows promising outcomes.The pulsed dye laser targets at micro-vascular structures in scar tissues. This study aims to explore the vascularity changes in scars with pulsed dye laser during the scar formation process.

Eligibility criteria: Inclusion Criteria:

* scars caused by burn injury or related trauma;
* wound healing days over 3 weeks;
* days post injury less than 1 year;
* ability and willingness to comply with all the treatment and assessment procedures.

Exclusion Criteria:

* history of steroid injection or graft surgery;
* history of keloid scarring;
* open wound or active infection;
* conditions that affect wound healing, such as diabetes mellitus.

Primary outcomes:
measure: scar erythema
timeFrame: 3 months
measure: scar blood flow
timeFrame: 3 months
measure: scar thickness
timeFrame: 3 months
Secondary outcomes:
measure: patient and observer scar assessment scale (POSAS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Cecilia Li-tsang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deng H, Li-Tsang CWP. Measurement of vascularity in the scar: A systematic review. Burns. 2019 Sep;45(6):1253-1265. doi: 10.1016/j.burns.2018.10.026. Epub 2018 Dec 10.
Clinical trial NCT03410446: Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care
Official title: A Phase II, Open-label Clinical Trial of Intranasal Ketamine for Depression in Patients With Cancer Receiving Palliative Care (INKeD-PC Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Cancer
Palliative Care
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 2 study of the drug ketamine for the treatment of depression in cancer patients receiving palliative care. The purpose of this study is to see how useful the drug is at decreasing the severity of depression these patients. Ketamine will be given through the nose.


Eligibility criteria: Inclusion Criteria:

* Provide written, voluntary informed consent prior to study enrollment. Participants must be capable of consenting to treatment as substitute decision makers will not be allowed to consent to the study on their behalf
* Males and females ≥ 18 years of age
* Patient is receiving palliative care at Princess Margaret Cancer Centre (PM) including all in-patient units and outpatients
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder (MDD), with a current Major Depressive Episode (MDE)
* Depression severity must be in the moderate to severe range, as determined by a Montgomery-Åsberg Depression Rating Scale (MADRS) score greater than or equal to 20
* Participants must have a confirmed diagnosis of cancer and an estimated life expectancy of less than twelve months, as determined by the palliative care physician

Exclusion Criteria:

* Presence of delirium or suspected delirium
* Severe hypertension or severe cardiac decompensation
* Previous stroke history
* History of intolerability, hypersensitivity or allergy to ketamine
* Patients with bipolar disorder, psychotic disorders, substance use disorders or active suicidality based on a Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician will also be excluded
* Current symptoms of psychosis or perceptual disturbances of any kind per investigator discretion
* Pregnancy or breastfeeding women

Primary outcomes:
measure: Greater than 25% of participants achieving a clinical response
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Madeline Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02781246: Effect of Perineural Dexmedetomidine on the ED50 Ropivacaine for Brachial Plexus Blocks in Pediatric Patients: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dose-Response Relationship, Drug
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine can prolong the duration of local anesthetics, but the effect of perineural dexmedetomidine on the potency of ropivacaine for brachial plexus blocks in pediatric patients has not been investigated. This study was designed to determine the effect of perineural dexmedetomidine on ropivacaine for brachial plexus blocks in pediatric patients

Detailed description: 150 children scheduled for arm and forearm surgery underwent supraclavicle brachial plexus blocks with ropivacaine guided by ultrasound visualisation were randomly assigned to one of the five groups: Group A (perineural ropivacaine), Group B (ropivacaine plus 0.5 mcg/kg dexmedetomidine), Group C (ropivacaine plus 1 mcg/kg dexmedetomidine), Group D (ropivacaine plus 1.5mcg/kg dexmedetomidine) and Group E (ropivacaine plus 2 mcg/kg dexmedetomidine). The primary endpoint was the minimum local anesthetic concentration (MLAC), which was determined using the Dixon up-and-down method. The secondary endpoints were the duration of analgesia and sedation

Eligibility criteria: Inclusion Criteria:

* ASA I,II children, aged between 2 and 6 years, who were scheduled for arm and forearm surgery underwent supraclavicular brachial plexus blocks.

Exclusion Criteria:

* any subjects with neurological, neuromuscular, psychiatric, or blood clotting disorders, or known history of active and severe renal, hepatic, respiratory, or cardiac diseases, or known allergy to systemic or local anesthetics or dexmedetomidine

Primary outcomes:
measure: the minimum local anesthetic concentration (MLAC)
timeFrame: up to 30 minutes after brachial plexus blocks
measure: Postoperative pain
timeFrame: up to 12 hours after brachial plexus blocks
measure: The sedation status
timeFrame: up to 12 hours after brachial plexus blocks
Secondary outcomes:
measure: pulse oximetry
timeFrame: up to 12 hours after brachial plexus blocks
measure: heart rate
timeFrame: up to 12 hours after brachial plexus blocks
measure: noninvasive arterial blood pressure
timeFrame: up to 12 hours after brachial plexus blocks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02113046: Pancreatic Stump Closure After Distal Pancreatic Resection
Official title: Prospective Randomized Study to Decrease Pancreatic Fistula Rate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Distal Pancreatic Resections
Keywords: pancreas
pancreatico-jejunal anastomosis
postoperative pancreatic fistulae
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate whether finnish binding pancreatico-jejunal anastomosis is feasible and prevents the risk for post operative pancreatic fistula after distal pancreeatectomy.


Eligibility criteria: Inclusion Criteria:

* patiens which the distal pancreatic resektions
* the type of resections that is techically possible with finnish binding panceatico-jejunal anastomosis

Exclusion Criteria:

* if the pancreas is not suitable for this kind of anastomosis

Primary outcomes:
measure: postoperative pancreatic fistula rata
timeFrame: 30 days
Secondary outcomes:
measure: Number of patients with resection margin on the left side of portal vein as a measure of feasibility.
timeFrame: 30 days
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University hospital
Study officials:
References:
Clinical trial NCT05545046: Predictive Model for Pain After TACE
Official title: A Predictive Model for Pain After Transarterial Chemoembolization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Yantai Yuhuangding Hospital
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 228
Sex: ALL
Minimum age (years): 34
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A diagnosis of HCC was confirmed either histologically or based on consistent findings obtained from at least two imaging techniques.

Brief summary: The main aim of this study was to analyze the risk factors that helped to predict the pain after transarterial chemoembolization (TACE).This was a prospective observational study enrolled all hepatocellular carcinoma (HCC) patients undergoing TACE in our hospital. Pain score at rest was assessed after TACE by the patients themselves using a Visual Analogue Scale (VAS). Independent variables such as age, gender, tumor location, tumor size and number, drug delivery method and presence of portal vein tumor thrombosis (PVTT) were recorded and analyzed.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of HCC was confirmed either histologically or based on consistent findings obtained from at least two imaging techniques.

Exclusion Criteria:

* patients aged \< 18 year
* significant heart or lung dysfunction
* use of additional analgesics to relieve pain during TACE
* cognitive impairment
* use of psychiatric medications
* drug or alcohol abuse

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 0 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
measure: Visual Analogue Scale (VAS)
timeFrame: 2 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
measure: Visual Analogue Scale (VAS)
timeFrame: 4 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
measure: Visual Analogue Scale (VAS)
timeFrame: 6 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
measure: Visual Analogue Scale (VAS)
timeFrame: 12 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
measure: Visual Analogue Scale (VAS)
timeFrame: 24 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
Secondary outcomes:
Other outcomes:
Locations:
city: Yantai
country: China
facility: Yuhuangding Hospital
state: Shandong
Study officials:
References: