louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04742660: The Effect of Glycyrrhizin on the Occurrence of Postoperative Nausea and Vomiting
Official title: The Effect of Administration of Glycyrrhizin During Induction Period on the Occurrence of Postoperative Nausea and Vomiting After Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 224
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The anticipants are administered either ramosetron+placebo or ramosetron+glycyrrhizin
Primary purpose: PREVENTION

Brief summary: The investigators investigate the association between the administration of glycyrrhizin during induction of general anesthesia and the occurrence of postoperative nausea and vomiting (PONV) in patients undergo breast surgery

Detailed description: Postoperative nausea and vomiting (PONV) is one of a common complication after general anesthesia with 30-50% of incidence, increased up to 80% in high risk group. The risk factors of PONV include women population, the previous history of PONV, motion sickness in usual life, non-smoker, exposure to inhalants, perioperative opioid and laparoscopic surgery. Women population is a strong risk factor of PONV. Although perioperative management of PONV based on a guideline has been done in a lot of medical centers worldwide, the incidence of PONV is still reported relatively high.

The main ingredient of Glycyrrhizin is liquorice which has been used as antispasmodics, antiemetics or treatment for gastric ulcer in oriental medicine. Utilizing these effects of liquorice, the investigators investigate whether the addition of glycyrrhzin to conventional antiemetics is effective to decrease the incidence of PONV and improvement of severity of PONV.

Eligibility criteria: Inclusion Criteria:

* participants scheduled to undergo breast surgery aged 20 and above

Exclusion Criteria:

* aldosteronism
* electrolyte imbalance
* myopathies
* drug addiction or suspected
* bowel disease
* allergy to drugs
* smoker
* taking any medications

Primary outcomes:
measure: the incidence of postoperative nausea and vomiting (PONV)
timeFrame: up to 24 hours after discharge from postanesthetic care unit (PACU)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Seoul-T'ǔkpyǒlshi
Study officials:
affiliation: Konkuk University Medical Center
name: Sung-Hyop Kim, M.D. Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01907191: Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy
Official title: Comparison of Bupivacaine to Liposomal Bupivacaine for Ultrasound Guided Periarticular Hip Infiltration for Postoperative Analgesia After Hip Arthroscopy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Injuries
Keywords: Hip Arthroscopy
Liposomal Bupivacaine
Bupivacaine
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 23
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: This study is being undertaken to compare the pain control using either bupivacaine versus liposomal bupivacaine. Liposomal bupivacaine can potentially provide pain relief lasting up to 72 hours while regular bupivacaine can provide pain relief up to 12 hours

Detailed description: Patients undergoing hip arthroscopy experience moderate to severe postoperative pain. Effective pain control after surgery is an important component in the overall management of these patients. Good pain control encourages early participation in rehabilitation program, increases success of the surgery, and improves patient satisfaction. Typically, postoperative analgesia is provided to these patients either with nerve blocks or opioid medications. Both these methods provide good pain relief but nerve blocks are associated with weakness of lower extremity muscles which interferes with early ambulation and increase the risk of falls while narcotic medications increase the risk of nausea, vomiting, itching, constipation, ileus, urinary retention, sedation and respiratory depression.

Eligibility criteria: Inclusion Criteria:

* Patients having hip arthroscopy

Exclusion Criteria:

* History of neurologic disease, neuropathy, diabetes
* Allergy to local anesthetic solution
* Chronic use of narcotics
* Inability to give consent/cooperate with study
* History of previous hip arthroscopy on the ipsilateral side
* Pregnancy

Primary outcomes:
measure: Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed)
timeFrame: Post Operative Day 1, 2 & 3
Secondary outcomes:
measure: Pain Scores
timeFrame: Post Operative Day 1, 2 & 3
Other outcomes:
measure: Number of Patients Reporting Sleep Disturbance
timeFrame: Post Operative Day 1, 2 & 3
measure: Satisfaction With Pain Management
timeFrame: Post Operative Day 1, 2 & 3
Locations:
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
Study officials:
affiliation: Saint Francis Hospital and Medical Center
name: Sanjay Sinha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00447291: Safety & Efficacy of Omega-3 Fish Oil in Overweight Children & Adolescents
Official title: Evaluation of the Safety and Efficacy of Omega-3 Fish Oil Dietary Supplementation in Biometric Measurement, Lipid Profile, Serum Markers for Inflammation, and Insulin Resistance in Overweight Children and Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Fish Oil
Lead sponsor: Children's Heart Center
Sponsor class: INDUSTRY
Collaborators: name: Zone Laboratories, Inc.
First posted: 2007-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Children with an excess in body weight, increase the risk of obesity-related co-morbidities and cardiovascular diseases. Childhood obesity may be due to diets laden with fat and lack of physical activity. Omega-3 fish oil is a supplementation that may promote a greater reduction of pro-inflammatory mediators; combined with exercise and nutritional regimens it may also help improve glycemic, lipid markers, and body composition in overweight children and adolescents.


Eligibility criteria: Inclusion Criteria:

* Between 8-18 years old
* BMI ≥95th percentile
* Patient \& parent/guardian consent to participate
* Attendance of Risk Factor Reduction lifestyle modification program

Exclusion Criteria:

* Major surgical Procedure within 1 year
* Significant cardiovascular disease or other morbidity that preclude patients from following dietary regimen or exercising.
* Mentally Challenged
* Currently taking fish oil supplements, unless 1 month wash-out period is achieved.
* Diabetes

Primary outcomes:
measure: To compare effects between Omega 3 fish oil and placebo
timeFrame: 3 months
Secondary outcomes:
measure: To compare effects between Omega 3 fish oil and placebo
timeFrame: 3 months
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Children's Heart Center
state: Nevada
Study officials:
affiliation: Children's Heart Center
name: Gary A. Mayman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04153591: Efficacy and Safety of Direct Oral Anticoagulants for the Treatment of Mural Thrombus
Official title: Efficacy and Safety of Direct Oral Anticoagulants for the Treatment of Mural Thrombus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective chart review of MDMC patients from 4/1/2017 to 8/31/19 with newly diagnosed mural thrombus.

Brief summary: To describe the prescribing patterns at Methodist Dallas Medical Center (MDMC) for the treatment of newly diagnosed mural thrombus and to determine the efficacy and safety of DOACs apixaban, dabigatran, and rivaroxaban in comparison to warfarin.

With limited treatment guideline consensus, minimal evidence to support the use of DOACs for Left Atrial Appendage (LAA) thrombus and Left Ventricular Thrombus (LVT), and a lack of evidence for the use of DOACs in aortic thrombus, further research is warranted to determine the role of DOACs in the treatment of various mural thrombi in comparison to warfarin.

Detailed description: Retrospective chart review of MDMC patients from 4/1/2017 to 8/31/19 with newly diagnosed mural thrombus.

3.1. Study Methods

* Patients will be allocated into two groups: those who were prescribed DOACs upon discharge and those who were prescribed warfarin upon discharge
* Subgroup analyses will occur to evaluate the difference in efficacy and safety endpoints for patients into four categories including: those predisposed to mural thrombus by baseline risk factors (AFIB vs. ACS), location of the mural thrombus (atrial, ventricular, aortic), DOAC by agent (apixaban, rivaroxaban, dabigatran), and DOAC by scheduled dosing indication (AFIB vs. VTE).

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. MHS patients with newly diagnosed mural thrombus from 4/1/2017 to 8/31/19 identified by International Classification of Diseases (ICD) codes: I23.6, I240, I513, I7409, I7411, I7419, I82210, I82229

Exclusion Criteria:

1. Age \<18 years
2. Anticoagulant use at baseline (DOAC, LMWH, VKA)
3. Active cancer
4. Active bleeding
5. Pregnancy
6. Hospice or palliative care upon discharge
7. Warfarin that did not receive adequate bridging from parenteral anticoagulation
8. Non newly diagnosed mural thrombus

Primary outcomes:
measure: Efficacy of the direct oral anti-coagulants
timeFrame: from 4/1/2017 to 8/31/19
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Crystal Brown, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092391: A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)
Official title: A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Measles
Mumps
Rubella
Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 1997
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.


Eligibility criteria: Inclusion Criteria:

* Healthy children 12 to 18 months of age

Exclusion Criteria:

* History or prior exposure to measles, mumps, rubella or varicella
* History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin

Primary outcomes:
measure: Neutralizing antibodies to mumps at 6 weeks postvaccination
timeFrame: 6 weeks postvaccination
Secondary outcomes:
measure: Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination
timeFrame: 6 weeks and 1 year postvaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04403191: Usage of Multiple Drugs in Treatment of Postoperative Vomiting After Laparoscopic Appendectomy
Official title: Comparative Study Between Ondansetron, Isopropyl Alcohol Inhalation and Super Hydration in Treatment of Postoperative Emesis After Laparoscopic Appendectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: to Treat the Vomiting Frequently Occur Post-laparoscopic by Different Anti Emetic Drugs
Lead sponsor: King Abdul Aziz Specialist Hospital
Sponsor class: NETWORK
First posted: 2020-05-27
Enrollment: 240
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: 240 patients admitted to surgical I.C.U of King Abdul-Aziz specialist hospital for post-operative care after laparoscopic appendectomy surgery between March 2019 till February 2020. A Koivuranta Score to Predict Postoperative Nausea and Vomiting done preoperatively for all the patients and only those who had score of more than 3 on Koivuranta vomiting score (had more than 60% chance to develop PONV) enrolled in our study. And randomly allocated in one of three groups group A, B or C.

Brief summary: To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.

Detailed description: This prospective double-blind study done on 240 patients admitted to surgical I.C.U after laparoscopic appendectomy. Those who had preoperative Koivuranta vomiting score of more than 3 enrolled in our study. Every group contains 80 patients. Patients of group A received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group B received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours. The last group C received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours. The duration of the study was 24 hours post-operatively. As PONV is self-limited within 24 hours.

Eligibility criteria: Inclusion Criteria:

postoperative nausea and vomiting

Exclusion Criteria:

systemic disease as diabetes or hypertension local gastric diseases

Primary outcomes:
measure: numbers of vomiting attacks
timeFrame: for one day
Secondary outcomes:
Other outcomes:
Locations:
city: Taif
country: Saudi Arabia
facility: King abd el Aziz specialist hospital
Study officials:
References:
Clinical trial NCT01358591: Effect of a High Calcium Breakfast on Exercise Metabolism and Appetite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Fat Oxidation
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2011-05-23
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the effect of a high calcium breakfast on substrate metabolism during exercise and appetite throughout the day.


Eligibility criteria: Inclusion Criteria:

* Male
* Aged 18-45 years
* Physically active - able to run continuously for 1 h.

Exclusion Criteria:

* Smokers
* Food Allergies
* Metabolic Disorders
* Consuming herbal/dietary supplements
* Gastric Problems

Primary outcomes:
measure: Total fat oxidised during 60 min of exercise (g).
timeFrame: 1 hour
Secondary outcomes:
measure: Blood glucose concentration
timeFrame: 2 hour
measure: Serum Insulin Concentration
timeFrame: 2 hour
measure: Subjective appetite ratings
timeFrame: 3 hour
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne and Wear
Study officials:
References:
Clinical trial NCT03655691: ET-01 in Subjects With Lateral Canthal Lines, LCL-207
Official title: Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Crow's Feet
Lead sponsor: Eirion Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 79
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel dose groups
Primary purpose: TREATMENT

Brief summary: This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

Detailed description: This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.

Eligibility criteria: Inclusion Criteria:

* 25 - 65 years of age
* minimal to moderate Crow's Feet wrinkles at rest
* moderate to severe Crow's Feet wrinkles on contraction
* willingness to refrain from any product affecting skin remodeling
* female subjects must be not pregnant and non-lactating

Exclusion Criteria:

* history of adverse reactions to any prior botulinum toxin treatments
* history of vaccination or non-response to any prior botulinum toxin treatments
* botulinum toxin treatment in the prior 6 months
* present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
* history of peri-ocular surgery, brow lift or related procedures
* procedures affecting the lateral canthal region in the prior 12 months
* application of topical prescription medication to the treatment area
* female subjects who are pregnant or are nursing a child

Primary outcomes:
measure: Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
timeFrame: Week 2, 4, 8,12, and 18
measure: Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
timeFrame: Week 2, 4, 8,12, and 18
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baumann Cosmetic & Research Institute
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC
state: Florida
city: Metairie
country: United States
facility: Dermatology NOLA Inc.
state: Louisiana
city: Austin
country: United States
facility: Westlake Dermatology Clinical Research Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Eirion Therapeutics
name: Klaus Theobald, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01370291: Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) for First-episode Schizophrenia Patients:A Double-blinded , Randomized and Functional Magnetic Resonance Imaging (fMRI)Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Schizophrenia
Keywords: rTMS
Risperidone
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effects of repetitive transcranial magnetic stimulation(rTMS)in the first-episode Schizophrenic patients: the clinical and MRI findings


Eligibility criteria: Inclusion Criteria:

* Age between 16-45 years
* Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)
* PANSS\>=60
* First episode, and the patients haven't use any antipsychotic drugs

Exclusion Criteria:

* Suicide risk
* Diagnose of substance abuse/dependance
* Severe uncontrolled organic disease that may interfere in the patient´s participation in the study
* Contraindication to TMS:

  1. Implanted pacemaker
  2. Medication pump
  3. Vagal stimulator
  4. Deep brain stimulator
  5. Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
  6. Signs of increased intracranial pressure
* Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
* Estimated IQ less than 80
* Have a sibling or parent with epilepsy

Primary outcomes:
measure: PANSS
timeFrame: 1-6 weeks
Secondary outcomes:
measure: Total AHRS score
timeFrame: 1-6 weeks
measure: HAMD Score
timeFrame: 1-6 weeks
measure: CGI
timeFrame: 1-6 weeks
measure: fMRI
timeFrame: 0,6 week
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Yun chun Chen
state: Shaanxi
city: Xi'an
country: China
facility: Yun chun Chen
state: Shaanxi
Study officials:
affiliation: Department of Psychiatry, Xi Jing hospital, Xi'an, China
name: Qingrong Tan, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01935791: Investigating Brown Adipose Tissue Activation in Humans
Official title: Investigating Brown Adipose Tissue Activation in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Diseases
Keywords: Metabolic Diseases
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine what can activate brown adipose tissue (BAT).

Detailed description: We will investigate different stimuli (i.e. hormones) to determine which can stimulate BAT.

Eligibility criteria: Inclusion Criteria:

* aged \>18 years

Exclusion Criteria:

* medical conditions
* recreational drug use
* participation in other trials within the preceding 2 months
* blood donation within 3 months of study participation

Primary outcomes:
measure: Brown Adipose Tissue Activation Following Glucagon or Saline Infusion
timeFrame: 2hours
measure: Increase in Energy Expenditure Following Glucagon or Saline Infusion
timeFrame: 2hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College London
name: Waljit Dhillo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salem V, Izzi-Engbeaya C, Coello C, Thomas DB, Chambers ES, Comninos AN, Buckley A, Win Z, Al-Nahhas A, Rabiner EA, Gunn RN, Budge H, Symonds ME, Bloom SR, Tan TM, Dhillo WS. Glucagon increases energy expenditure independently of brown adipose tissue activation in humans. Diabetes Obes Metab. 2016 Jan;18(1):72-81. doi: 10.1111/dom.12585. Epub 2015 Nov 20.