louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03356899: Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering.
Official title: Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering in Cesarean Section: is There a Relation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section; Shivering
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Shivering is very common after spinal anaesthesia. Many studies have investigated the role of adding adjuvants to the local anaesthetics to decrease the incidence of post-spinal shivering. Non of the studies n the literature review have investigated the role of different dose of local anaesthetic alone in reducing the incidence of post-spinal shivering. In the present study the investigators aimed to compare the effect of different local anaesthetic dose in reducing post-spinal shivering.

Detailed description: After approval of the ethics committee, department of anaesthesia, Menoufia University and written informed consent, a hundred full-term pregnant ladies undergoing elective cesarean section were enrolled in this study.

The pregnant ladies were randomly assigned using a computerised software to one of two groups, low dose bupivacaine (LB) and high dose bupivacaine (HB), 50 patients each according to bupivacaine dose. Group LB received low dose bupivacaine (8 mg hyperbaric bupivacaine) Group HB received high dose bupivacaine (10 mg hyperbaric bupivacaine).

Vital signs including heart rate and mean arterial blood pressure intra-operatively until the end of surgery.

The severity of shivering was the primary endpoint. Shivering was graded using a scale: 0, no shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group of muscle; 3, muscular activity in more than one muscle group but not generalized movement; and 4, shivering involving the movement of the whole body. Shivering score was recorded for the whole study period.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 22 and 35 year old, and American Society of Anesthetists (ASA) I or II were included in the study and consented to have spinal anaesthesia for their section.

Exclusion Criteria:

* Patients who had contraindication to spinal anesthesia, high-risk pregnancy, history of seizures, mental illness, acute fetal distress, and patients refused spinal anesthesia were excluded from the study.

Primary outcomes:
measure: Shivering score
timeFrame: Peri-operatively
Secondary outcomes:
measure: Mean arterial blood pressure (mmHg)
timeFrame: Peri-operatively
measure: Heart rate (beat/minute)
timeFrame: Peri-operatively
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine, Menoufia Univeristy
Study officials:
affiliation: Professor
name: Ezzeldin Ibrahim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03482999: Case Series Assessing TissuGlu® Surgical Adhesive in Flap Surgery for Decubitus Repair
Official title: Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Assessing a Lysine-Derived Urethane Adhesive (TissuGlu® Surgical Adhesive) in Flap Surgery for Decubitus Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decubitus Ulcer
Lead sponsor: Cohera Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population included patients undergoing flap surgery for decubitus repair between March 2011 and July 2015. In October 2013, the investigator converted to the use of TissuGlu® Surgical Adhesive in conjunction with surgical drains as their standard of care for flap surgery for decubitus repair. The analysis was performed retrospectively on two consecutive cohort groups.

Brief summary: To evaluate the impact of a high strength lysine-based adhesive (TissuGlu® Surgical Adhesive) on complications and revision rates in large flap surgery for decubitus repair.

Detailed description: A total of 50 subjects undergoing flap surgery for decubitus repair at the Clinic for Plastic and Aesthetic Surgery, Hand Surgery, St. Joseph's Hospital in Hagen, Germany were included in a post-market investigator initiated, retrospective observational series study.

Eligibility criteria: Inclusion Criteria:

* undergoing a procedure for decubitus repair
* be 22 years of age or older

Exclusion Criteria:

* expected flap size less than 5 sqcm

Primary outcomes:
measure: reduce the post-operative duration of stay
timeFrame: 30 days
measure: reduce the surgical revision rate
timeFrame: 30 days
Secondary outcomes:
measure: percent of patients requiring a revision
timeFrame: 30 days
measure: duration of wound drainage
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05462899: Purpose in Life, Goals, and Expectations
Official title: Purpose in Life, Goals, and Expectations of Older Adults After Hospitalization and Their Caregivers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Goals
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults 60y+ and family caregivers after hospitalization

Brief summary: Study investigators are inviting participants to participate in a study to describe older adults' and family caregivers' purpose in life, goals, and expectations for recovery after hospitalization. Study investigators will ask older adults and caregivers to take part in a telephone or online interview to ask questions and answer questionnaires related to their experience with the hospitalization.


Eligibility criteria: Inclusion Criteria:

* Older adults 60y+ and family caregivers
* after hospitalization

Exclusion Criteria:

* We will exclude older adults with a dementia diagnosis, head injury, significant neurological impairment, not expected to live for 6 months or longer, or who receive treatment for medical conditions precluding enrolment.

Primary outcomes:
measure: Experience and perceptions after hospitalization
timeFrame: 1 day
Secondary outcomes:
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: 1 day
measure: Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
timeFrame: 1 day
measure: Life-Space questionnaire
timeFrame: 1 day
measure: Functional Independence Measure
timeFrame: 1 day
measure: Occupational Balance Questionnaire (Short form)
timeFrame: 1 day
measure: Telephone Interview for Cognitive Status (TICS) to screen for cognitive impairment
timeFrame: 1 day
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 day
measure: Ryff Scales of Psychological Well-Being
timeFrame: 1 day
measure: EQ5D-5L
timeFrame: 1 day
measure: ICECAP-O
timeFrame: 1 day
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: The University of British Columbia
state: British Columbia
Study officials:
affiliation: UBC
name: Maureen C Ashe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00093899: A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)
Official title: A Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Fenofibrate Coadministration in Patients With Mixed Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Hypercholesterolemia
Hypertriglyceridemia
Keywords: Mixed Hyperlipidemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-10-08
Enrollment: 611
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).


Eligibility criteria: Inclusion Criteria:

* Men and women 18-79 years of age with high cholesterol and high triglycerides.

Exclusion Criteria:

* Individuals who do not meet specific cholesterol or triglyceride levels as required by the study.

Primary outcomes:
measure: Plasma LDL-C.
Secondary outcomes:
measure: Plasma HDL-C, non-HDL-C, and TG. Tolerability
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Farnier M, Roth E, Gil-Extremera B, Mendez GF, Macdonell G, Hamlin C, Perevozskaya I, Davies MJ, Kush D, Mitchel YB; Ezetimibe/Simvastatin + Fenofibrate Study Group. Efficacy and safety of the coadministration of ezetimibe/simvastatin with fenofibrate in patients with mixed hyperlipidemia. Am Heart J. 2007 Feb;153(2):335.e1-8. doi: 10.1016/j.ahj.2006.10.031.
citation: Farnier M, Perevozskaya I, Taggart WV, Kush D, Mitchel YB. VAP II analysis of lipoprotein subclasses in mixed hyperlipidemic patients on treatment with ezetimibe/simvastatin and fenofibrate. J Lipid Res. 2008 Dec;49(12):2641-7. doi: 10.1194/jlr.P800034-JLR200. Epub 2008 Jul 31.
citation: Gil-Extremera B, Mendez G, Zakson M, Meehan A, Shah A, Lin J, Mitchel Y. Efficacy and safety of ezetimibe/simvastatin co- administered with fenofibrate in mixed hyperlipidemic patients with metabolic syndrome. Metab Syndr Relat Disord. 2007 Dec;5(4):305-14. doi: 10.1089/met.2007.0011.
Clinical trial NCT00611299: Dose-Response Study of Probiotic Bacteria BB-12 and CRL-431 in Healthy Young Adults
Official title: Dose-Response Study of Probiotic Bacteria Bifidobacterium Animalis Subsp. Lactis BB-12 and Lactobacillus Paracasei Subsp. Paracasei CRL-341 in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease
Constipation
Keywords: Probiotics
Immune response
Blood lipids
Intestinal microflora
Tolerance
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study was to investigate the dose-response effect of increasing doses of Bifidobacterium animalis ssp lactis (BB-12) and Lactobacillus paracasei ssp paracasei (CRL-431) on the immune response, blood lipids, gut microflora, recovery from feces and overall tolerance in healthy young adults.

Detailed description: The study included seventy-one healthy young vounteers, and was designed as a double-blind placebo controlled dose-response trial based on a 2 wk run-in period, a 3 wk intervention and 2 wk wash-out period. The subjects were randomly assigned into 5 groups of 15 subjects each, who were supplemented with 0, 10E8, 10E9, 10E10 or 10E10 CFU/d, respectively, og a mixture of BB-12 and CRL-431. Blood samples were collected 4 times and fecal samples 3 times. Diary reporting bowel habits and weel being was kept for all 7 weeks.

There are very few articles concerning the issue dose-response effect of probiotics.The aim of the study was to investigate the dose-response effect of increasing concentrations of probiotics on the immune response, blood lipids, composition of the gut microflora, recovery from feces and the overall tolerance.

The hypothesis was that the increasing dose would influence the immunresponse (eg incresae phagocytosis), improve blood lipid profile (eg.lower HDL-cholesterol), would be recovered in increasing concentrations in feces, would change the intestinal microfloraprofile and would be well tolerated even in high doses.

Eligibility criteria: Inclusion Criteria:

* Healthy young individuals

Exclusion Criteria:

* GI-disease
* Colosomi
* Pregnant or lactating women
* Allergy
* Individuals receiving the following medicine: antacid, antibiotics, steroids, medicine with influence the intestinal function.

Primary outcomes:
measure: Modulation of the immune system
measure: Influence on blood lipids
measure: Bioavailibility of BB-12 and CRL-341
measure: Overall tolerance
measure: Effect on the composition of the gut microflora
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Human Nutrition
Study officials:
affiliation: Michaelsen KF
name: Kim F Michaelsen, Prof dr med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05016999: Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.
Official title: Evaluation of the Effect of the Consumption of a Combination of Allium Extracts on the Intestinal Microbiota in Healthy Elderly Resident Volunteers. Preliminary Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Bacteria Flora Disturbance
Keywords: Garlic
Onion
Microbiota
Lead sponsor: DOMCA S.A.
Sponsor class: INDUSTRY
First posted: 2021-08-23
Enrollment: 53
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: To evaluate the effect of daily consumption of a combination of garlic and onion extracts on the intestinal microbiota and the production of short chain fatty acids in elderly healthy volunteers living in a residence.

Likewise, any incident related to health that occurred during that period will be noted.

Detailed description: This study is a continuation of another (C002, registration number NCT04647071).

The volunteers from study C002 were invited to participate in this new study and, by the end of C002, all gave 2 stool samples.

After 4 weeks of washout, the control group volunteers in C002 will begin consuming 1 capsule per day of garlic and onion extract after lunch. The intervention group volunteers in C002 will not consume anything.

During 36 weeks any incident related to the health of the volunteers will be noted. Likewise, during this time, the volunteers will maintain their lifestyle and eating habits.

At 36 weeks, 2 stool samples will be taken from all volunteers.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 65 years or older who participated in study C002.
* 2. Living in the Claret Residence for the Elderly in Granada during the study.
* Accept being vaccinated for the flu.
* Freely accepted to participate in the study and sign the informed consent document.
* Have the consent of the family.

Exclusion Criteria:

* Having any disease that affects the development and results of the study.
* Be unable to understand the study and sign voluntarily and freely the informed consent.
* Have a low expectation of compliance with the study protocol.

Primary outcomes:
measure: Changes in bacterial species in feces.
timeFrame: 36 weeks.
measure: Short chain fatty acids in stool.
timeFrame: 36 weeks.
Secondary outcomes:
measure: Events during 36 weeks.
timeFrame: 36 weeks
measure: Medication during 36 weeks.
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Residencia de Mayores Claret
Study officials:
affiliation: Claret Residence for the Elderly (Granada, Spain).
name: Carlos Gracián Alcaide, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01595399: Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
Official title: Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bradycardia
Hypoxemia
Keywords: bradycardia
hypoxemia
intubation
premedication
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare heart rate in infants who receive atropine as a part of their medication before intubation to those who do not.

To be able to find out , we need to divided babies into 2 groups;

group 1 : receives atropine + sedation + muscle relaxant group 2 : receives water or saline ( placebo group) + sedation + muscle relaxant

Then we need to compare heart rate during intubation and duration of intubation between the 2 groups.

Detailed description: We hypothesize that premedication for intubation with fentanyl and succinylcholine alone will maintain equal stability of heart rate and oxygen saturation without a prolongation of time to completion of intubation when compared to a protocol using atropine, fentanyl and succinylcholine.

In order to answer this question we plan to undertake a prospective randomized double blinded control trial of use of atropine as an adjunct for elective intubation of infants less than 46 weeks postmenstrual age.

Eligibility criteria: Inclusion Criteria:

* Any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation.
* IV access is obtained
* Informed parental consent

Exclusion Criteria:

* Emergent intubation or need for resuscitation
* Congenital cyanotic heart disease
* Obvious airway abnormalities
* History of myopathy or family history of malignant hyperthermia or known history of phosphocholinesterase deficiency

Primary outcomes:
measure: Heart rate less than 80 BPM and oxygen saturation less than 80%
timeFrame: 5-6 minutes
Secondary outcomes:
measure: Heart rate < 100 BPM
timeFrame: 5-6 minutes
measure: Oxygen saturation < 85%
timeFrame: 5-6 minutes
measure: Duration of intubation attempts
timeFrame: 1-2 minutes
measure: Number of intubation attempts
timeFrame: 5-6 minutes
measure: Lowest heart rate after premedication
timeFrame: 5-6 minutes
measure: Lowest oxygen saturation after premedication
timeFrame: 5-6 minutes
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Michael R Narvey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00710099: Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate in Healthy Volunteers
Official title: Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate on Cutaneous Blood Flow in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: iontophoresis
cutaneous microcirculation
sildenafil
Healthy volunteers
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2008-07-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study investigates cutaneous microcirculation when we associate sildenafil per os with SNP via iontophoresis.

Detailed description: The main outcome is the proof of concept of effect of systemic absorption sildenafil on cutaneous microcirculation associated with SNP iontophoresis.

Eligibility criteria: Inclusion Criteria:

* Age over 18
* No significant medical history

Exclusion Criteria:

* Age under 18
* Period of exclusion for an other study
* Pregnancy
* Breast feeding
* Severe disease
* Cigarette smoking

Primary outcomes:
measure: variation of conductance of nitroprussiate iontophoresis associated with oral sildenafil
timeFrame: one hour
Secondary outcomes:
measure: To assess the effect of oral sildenafil (50 mg and 100 mg) on skin microvascular reactivity to local cooling, on the forearm and the finger
timeFrame: one hour
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinical Researsh Centre
state: Isere
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Jean-Luc CRACOWSKI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cracowski JL, Minson CT, Salvat-Melis M, Halliwill JR. Methodological issues in the assessment of skin microvascular endothelial function in humans. Trends Pharmacol Sci. 2006 Sep;27(9):503-8. doi: 10.1016/j.tips.2006.07.008. Epub 2006 Jul 31.
Clinical trial NCT01391299: Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines
Official title: A Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Single Treatment Cycle Study of BOTOX® Cosmetic (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects With Forehead and Glabellar Rhytides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Rhytides
Glabellar Frown Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 175
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).


Eligibility criteria: Inclusion Criteria:

* Moderate to severe forehead lines

Exclusion Criteria:

* Current or previous botulinum toxin treatment of any serotype within one year
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* Prior facial cosmetic surgery (e.g. prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
* Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
* Oral retinoid therapy within one year

Primary outcomes:
measure: Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation
timeFrame: Day 30
measure: Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation
timeFrame: Day 30
Secondary outcomes:
measure: Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines
timeFrame: Day 30
measure: Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest
timeFrame: Baseline, Day 30
measure: Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest
timeFrame: Baseline, Day 30
Other outcomes:
Locations:
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Solish N, Rivers JK, Humphrey S, Muhn C, Somogyi C, Lei X, Bhogal M, Caulkins C. Efficacy and Safety of OnabotulinumtoxinA Treatment of Forehead Lines: A Multicenter, Randomized, Dose-Ranging Controlled Trial. Dermatol Surg. 2016 Mar;42(3):410-9. doi: 10.1097/DSS.0000000000000626.