louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00624390: Sepraspray™ Laparoscopic Myomectomy Study
Official title: A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Myomectomy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-27
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to obtain preliminary data of the safety and effectiveness of Sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion prevention barrier after laparoscopic myomectomy versus no adhesion barrier.


Eligibility criteria: Inclusion Criteria:

* The patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and SLL.

Exclusion Criteria:

* Pregnant/lactating women.
* The patient has a history of hypersensitivity to exogenous carboxymethylcellulose products and/or hyaluronic acid.
* The patient's procedure resulted in entry of the endometrial cavity, or entry of the bowel including appendectomy.

Primary outcomes:
measure: The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage.
timeFrame: 30 Days post surgery
measure: Efficacy endpoints are on adhesion formation and will include the success the success criterion for the individual patients as either anterior or posterior uterus free of dense adhesions.
timeFrame: Until end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Naperville
country: United States
state: Illinois
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04862390: Incidence of Hypoglycemia in Pregnant Ladies With or Without Gestational Diabetes Fasting Ramadan
Official title: Incidence of Hypoglycemia in Pregnant Women With or Without Diabetes During Fasting in Ramadan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy in Diabetic
Keywords: Pregnant, gestational diabetes, fasting
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant ladies without gestational diabetes (GDM) and with GDM on diet or metformin attending the endocrine and obstetric clinics at National Guards Hospital Jeddah, and who intend to fast Ramadan will be recruited over 2 months period prior to Ramadan. Those who accept and fulfill the inclusion criteria will be consented to participate. During Ramadan they will be requested to do home glucose monitoring which is part of standard of care and will also be put on glucose sensors for 14 days, after which reprots will be downloaded

Brief summary: The physiological change in food and sleep pattern during Ramadan impacted hypoglycemia risks among pregnant women. Few studies investigated the incidence of hypoglycemia pregnant women with or without diabetes during fasting in Ramadan in Saudi Arabia. This study aims to understand the glucose variability in pregnant women during fasting Ramadan in Saudi Arabia.

Detailed description: Women with normal pregnancy will be compared to women with gestational diabetes on diet or Metformin alone during Fasting Ramadan. They will be monitored and will be observed for incidence of hypoglycemia using continuous glucose monitoring devices.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old.
2. Pregnant women without diabetes.
3. Pregnant women with diabetes (pregestational and gestational) on diet +/- metformin.
4. Dedicated to applying a continuous glucose monitoring (CGM) device.

Exclusion Criteria:

1. Age below18 years
2. Pregnant women with diabetes on insulin (type 1 and type 2 diabetes)
3. Renal and liver impairment.
4. Adrenal insufficiency
5. Psychiatric diseases.

Primary outcomes:
measure: Hypoglycemia incidence with fasting
timeFrame: 1 month
Secondary outcomes:
measure: Glucose variability during fasting Ramadan
timeFrame: 1 month
measure: Number of days that needed to break fasting
timeFrame: 1 month
measure: Time in range (TIR)
timeFrame: 1 month
measure: Time above range (TAR)
timeFrame: 1 month
measure: Time below range (TBR)
timeFrame: 1 month
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: KingAbullahIMRC
Study officials:
affiliation: King Abdullah International Medical Research Center
name: Reem M Alamoudi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00862290: Circulating microRNAs as Biomarkers of Sepsis
Official title: Diagnostic and Predictive Value of Circulating microRNAs During Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sepsis
microRNA
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2009-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who develop sepsis and SIRS

Brief summary: MicroRNA has been demonstrated to play a crucial role in regulating cell processes. Recently, microRNA was identified to exist in human serum or plasma, and it might be related to certain diseases. Several microRNAs are involved in sepsis, such as miR-146, miR-155, and so on. But whether serum miR-146 is present in serum of septic patients remains unknown. The present study was designed to identify the existence of specific microRNAs, which might be new markers for sepsis and its prognosis.


Eligibility criteria: Inclusion Criteria:

* patients who develop sepsis and undergo abdominal surgery
* patients who develop SIRS after cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* patients with a primary diagnosis of acute pancreatitis
* patients with cirrhosis or renal dysfunction
* patients with dyscrasia
* patients with autoimmunity diseases
* patients with severe cardiac and pulmonary diseases
* patients with hematological diseases
* patients who had organ dysfunction after cardiac surgery with cardiopulmonary bypass

Primary outcomes:
measure: Relative amount of circulating microRNAs
timeFrame: On the second day of diagnosis of sepsis in ICU
Secondary outcomes:
measure: Serum levels of CRP and IL-6
timeFrame: On the second day of diagnosing sepsis
measure: Apache II score and death
timeFrame: On the second day of diagnosis of sepsis
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Unit
name: Ke-ming Zhu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang JF, Yu ML, Yu G, Bian JJ, Deng XM, Wan XJ, Zhu KM. Serum miR-146a and miR-223 as potential new biomarkers for sepsis. Biochem Biophys Res Commun. 2010 Mar 26;394(1):184-8. doi: 10.1016/j.bbrc.2010.02.145. Epub 2010 Feb 24.
Clinical trial NCT00756990: Depot Naltrexone Treatment of Opioid Dependent Parolees
Official title: Depot Naltrexone Treatment of Opioid Dependent Parolees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Dependence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-09-22
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an investigation involving the use of a long-acting, injectable form (depot) of naltrexone as a treatment for persons who have a history of opioid dependence, with up to 40 on parole/probation and 20 non-parolees. The test is a pilot study of up to 60 subjects treated with 6 months of depot naltrexone plus Psychosocial Treatment .

Detailed description: This is a two phase study. Phase 1 is complete and phase 2 is not yet recruiting.

Eligibility criteria: Inclusion/Exclusion Criteria.

To be eligible to participate, participants must:

* sign an informed consent form;
* be between the ages of 18 and 55;
* have a diagnosis of opioid dependence according to DSM IVTR criteria; and
* be in good general health as determined by complete physical examination and laboratory tests;
* have been assigned to a probation/parole period of at least six months; (except those participants not on parole/probation, see note below); and
* have a negative result for urinary opioids and must self report being at least 3 days opioid free. Participants may have a diagnosis of alcohol dependence so long as they do not have severe alcohol dependence that requires medical supervision for alcohol withdrawal.

Participants with the following characteristics will be excluded from study participation:

* current severe alcohol dependence that requires medical supervision for alcohol withdrawal;
* current psychosis, dementia, mental retardation, or history of schizophrenia;
* significant clinical abnormalities in hematology, chemistry, or urinalysis;
* significant clinical cardiovascular, neurological, hepatic, renal, pulmonary, metabolic, endocrine, or gastrointestinal disorders;
* female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using birth control (oral contraceptives, barrier (diaphragm or condom) plus spermicide, or levonorgestriel implant);
* subjects who have taken an opioid antagonist within the prior 6 months; and
* current diagnosis of chronic pain disorder.

Primary outcomes:
measure: UDS results
timeFrame: 6 months
Secondary outcomes:
measure: Treatment completion
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Charles O'Brien, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00606190: Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
Official title: Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysm of Aortic Arch
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-02-01
Enrollment: 123
Sex: ALL
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery.

Detailed description: The purpose of the clinical trial is to assess the best method of protecting the brain during long periods of circulatory arrest. The significance of this project will be to determine which method of brain protection (1) retrograde brain perfusion or (2) perfusion of the right subclavian artery with antegrade perfusion of the brain protects against brain injury after total arch replacement. Thus reducing the risk of stroke or neurocognitive deficits in patients undergoing this critical surgical procedure.

Eligibility criteria: Inclusion Criteria:

* Undergoing a total arch replacement
* Less than 75 years old

Exclusion Criteria:

* EF less than 35%
* Pt shows evidence of major illness e.g. severe hepatic disease, severe renal failure, active cancer or major infection
* Pt unable to complete preop neuro assessment
* Pt is unwilling or able to complete followup requirements
* Pt is already enrolled in other new device or drug protocols that have not completed the primary endpoint or that clinically interferes with study endpoint
* Pt is a female who is pregnant or lactating
* Pt has history of stroke

Primary outcomes:
measure: To determine what is the best method of brain protection during long periods of circulatory arrest
timeFrame: 6 months
Secondary outcomes:
measure: Will one method of brain protection be better than the other in prevention of post-op stroke and which method will provide freedom from postop neurobehavioural deficit at 6 months postop.
timeFrame: 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Lars Svensson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Svensson LG, Blackstone EH, Apperson-Hansen C, Ruggieri PM, Ainkaran P, Naugle RI, Lima B, Roselli EE, Cooper M, Somogyi D, Tuzcu EM, Kapadia S, Clair DG, Sabik JF 3rd, Lytle BW. Implications from neurologic assessment of brain protection for total arch replacement from a randomized trial. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1140-7.e11. doi: 10.1016/j.jtcvs.2015.07.054. Epub 2015 Jul 26.
Clinical trial NCT04814290: Long-term Follow-up of Living Liver Donors: A Single-center Experience
Official title: Long-term Follow-up of Living Liver Donors: A Single-center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Keywords: Living-donor liver transplantation
Quality of life
Follow up
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 237 living liver donors and 239 matched controls.

Brief summary: Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up.

Detailed description: Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up.

We used the 36-item short-form health survey (short form-36 health survey, version 1 \[SF-36\]). The scores for the 4 following subscales were higher in nondonors than in donors: physical functioning (P = 0.009), role limitations due to physical health (P = 0.002), energy/fatigue (P \< 0.001), and bodily pain (P \< 0.001). The scores on the 8 subscales of the SF-36 were higher in donors with living recipients than in donors whose recipients died (P \< 0.001). Our results suggest that living donor right hepatectomy is safe and results in a postdonation HRQoL similar to that of nondonors in those donors whose recipients are healthy, while donors whose recipients die have a lower HRQoL that is significantly negatively correlated with the time since recipient death and improves over time.

Eligibility criteria: Inclusion Criteria:

* age 18-50 years
* no comorbidities.
* BMI less than 30 kg/m2.
* compatible ABO group.

Exclusion Criteria:

* Older than 50 years.
* Associated comorbidities.
* Obesity.
* Noncompatible ABO group.

Primary outcomes:
measure: health-related quality of life (HRQoL)
timeFrame: 4 to 16 years of follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00664690: Effect of Celecoxib on Transitional Pain After Outpatient Surgery
Official title: Effect of Celecoxib on Transitional Pain After Outpatient Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain
Keywords: shoulder surgery
analgesia
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2008-04-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty adults having shoulder and forearm surgery will receive either placebo or celebrex started preoperatively and continued for 3 days. Rescue medications required as well as pain scores will be assessed using a patient diary to evaluate the effect of celebrex in controlling transitional pain


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective ambulatory surgery of the shoulder
* ASA I - III
* Able to read English
* Male or female

Exclusion Criteria:

* Allergy to local anesthetic, Cox2, sulpha drug, acetaminophen or oxycodone
* Women who are pregnant or lactating and women of childbearing age and not following acceptable contraceptive precautions
* Any major medical or psychiatric problem
* Those with a known history of narcotic dependence, abuse or chronic narcotic intake
* Patients with known history of peptic ulcer or GI bleeding in the past, ulcers, congestive heart failure, angina or previous heart attack, coagulation problems, venous thrombosis, kidney or liver disease or strokes

Primary outcomes:
measure: visual analogue score for pain
timeFrame: post-op period
Secondary outcomes:
measure: severity of nausea
timeFrame: post-op period
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Ngozi Imasogie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00234390: PreAsthmaControl (PAC)
Official title: Prevention of Asthma in Infants/Young Children - PAC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 400
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the ability of budesonide, given during episodes of troublesome lung symptoms to reduce further symptoms in infants and young children at risk of developing asthma


Eligibility criteria: Inclusion Criteria:

* Children of asthmatic mothers form the COPSAC birth cohort study

Exclusion Criteria:

* Children born more than 4 weeks preterm
* children with other systemic illness that atopy/allergy
* Children requiring mechanical ventilation at any time since birth.

Primary outcomes:
measure: symptom free days
measure: days with no use of bronchodilator
measure: days with no use of bronchodilator and no symptoms
measure: number of treated episodes
measure: number of treatment with add-on medication
Secondary outcomes:
measure: asthma status
measure: time to start of algorithm treatment
measure: the total steroid dose
measure: First treatment episode:
measure: number of symptom days
measure: number of days with use of bronchodilator
measure: number of patients who needed add-on medication
measure: BMD
measure: height
measure: serious adverse events
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AB CNS Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Bisgaard H, Hermansen MN, Loland L, Halkjaer LB, Buchvald F. Intermittent inhaled corticosteroids in infants with episodic wheezing. N Engl J Med. 2006 May 11;354(19):1998-2005. doi: 10.1056/NEJMoa054692.
Clinical trial NCT03845790: Pharmacokinetic Study of Vancomycin, Clindamycin And/or Gentamicin Administration During Surgery Using a Microdialysis Procedure
Official title: Pharmacokinetic Study of Vancomycin, Clindamycin And/or Gentamicin Administration During Surgery Using a Microdialysis Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Surgical Site Infection
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pharmacokinetic study
Primary purpose: OTHER

Brief summary: The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective way to prevent surgical site infections. The beta-lactam are the most frequent antibiotics recommended for surgical prophylaxis and patients known to be allergic to beta-lactam are more likely to presented surgical site infection, probably due to use of others antibiotic such as vancomycin or clindamycin.

The main objective of the study is to describe the tissu and plasma pharmacokinetics of vancomycin, clindamycin and gentamicin using as surgical antibiotic prophylaxis in patients with beta-lactam hypersensivity and to predict the probability of target attainment for usual bacteria.


Eligibility criteria: Inclusion Criteria:

* Adult patient between 18 and 80 years old
* Patient with history of beta-lactam hypersensitivity
* Patient who underwent abdominal or orthopedic surgery whose forseeable time exceeds 1 hour and requires a surgical antibiotic prophylaxis by vancomycin or clindamycin + gentamicin

Exclusion Criteria:

* morbid obesity (BMI \> 35 kg/m2)
* mild to severe renal impairment (clearance creatinine \< 60 ml/min)
* vancomycin, clindamycin or gentamicin hypersensitivity
* pregnancy

Primary outcomes:
measure: Total and free plasma of vancomycin, clindamycin or gentamicin
timeFrame: 24 hours
measure: Free tissue concentration of vancomycin, clindamycin or gentamicin every 20 minutes after the beginning of injections
timeFrame: 24 hours
measure: Probability of target attainment of PK/PD index for usual bacteria (AUC/CMI >1 for vancomycin and clindamycin, Cmax/CMI >8 for gentamicin) with the recommended dosing regimen
timeFrame: 2 days
Secondary outcomes:
measure: Probability of target attainment of PK/PD index for usual bacteria (AUC/CMI >1 for vancomycin and clindamycin, Cmax/CMI >8 for gentamicin) with new simulated dosing regimens.
timeFrame: 2 days
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References: