louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02712216: Evaluation of Abdominal Wall Thickness at Possible Trocar Sites Based on Body Mass Index
Official title: Evaluation of Abdominal Wall Thickness at Possible Trocar Sites Based on Body Mass Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to determine which sites are best suited for laparoscopic entry of bariatric trocars in the morbidly obese population.

Detailed description: Patients already scheduled for laparoscopy will be approached for participation prior to surgery. During laparoscopy, the investigators routinely inject port sites with a 21-gauge needle and inject sites with local anesthetic prior to trocar placement. In the study the investigators will insert a 21-gauge 3.5inch spinal needle perpendicular to the abdominal wall at each possible trocar site. The seven insertion sites are the umbilicus; 12cm lateral to umbilicus on right; 12cm lateral to umbilicus on left; Left lower quadrant lateral to inferior epigastric; Right lower quadrant lateral to inferior epigastric, Lower midline of abdomen; Left upper quadrant at Palmer's Point. The needle will be placed after the abdomen is insufflated under direct visualization with the laparoscopic camera. The needle will be inserted to the level of the peritoneum and a hemostat will be place on the needle at the level of the epidermis. The abdominal wall thickness will be measured with a ruler and recorded to the nearest millimeter. The information will be recorded on the case report form attached. The case report form will be kept in a binder in the research coordinators office.

Eligibility criteria: Inclusion Criteria:

* Patients between the age of 18-64; BMI greater than 18.5

Exclusion Criteria:

* Abdominal hernias

Primary outcomes:
measure: Measurement of abdominal wall depths
timeFrame: Measurement of abdominal wall depth will occur during the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Flowood
country: United States
facility: University Physician's Grant's Ferry
state: Mississippi
city: Flowood
country: United States
facility: University Physician's Women's Specialty Care
state: Mississippi
city: Jackson
country: United States
facility: University's Physician Specialty Clinics Jackson Medical Mall
state: Mississippi
city: Jackson
country: United States
facility: Winfred L. Wiser
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Elizabeth Lutz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04833816: Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient
Official title: Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Traumatic Injury
Keywords: ketamine
analgesia
ISS
trauma
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to demonstrate a significant reduction of at least 25% in opioid consumption at 48 hours of management of severe trauma, while demonstrating non-inferiority in terms of analgesia, in a group of patients receiving a continuous infusion of low dose ketamine compared to a placebo group.


Eligibility criteria: Inclusion Criteria:

* Male or female adult
* Trauma patient presenting at least 2 lesions in two different regions as defined by the ISS (injury severity score) (Head or neck, Face, Thorax, Abdomen and pelvic contents, Upper limbs or pelvic girdle, Lower limbs, External (any skin surface).
* Patient presenting at least two regional disorders classified as moderate to maximum defined by an AIS (Abbreviated Injury Scale)\> 1.
* Patient having signed an informed consent

Exclusion Criteria:

* Patients with an indication for deep sedation (intracranial hypertension or acute respiratory distress syndrome).
* Patient in whom the infusion could not be started within the first 6 hours of initial treatment.
* Patient whose state of consciousness is incompatible with understanding the protocol.
* Patient with chronic unbalanced arterial hypertension.
* Patient with severe heart failure.
* Patient with a BMI\> 35 kg / m² or a weight of more than 120 kg.
* Patient with chronic analgesic consumption defined by consumption of opioid derivatives for more than a week for an intercurrent illness.
* Presence of a history of chronic pain.
* Presence of a history of epilepsy.
* Presence of a history of psychosis or drug addiction.
* Presence of a history of stroke.
* Patients with an allergy to the molecule or excipients composing ketamine
* Patients with an allergy to the molecule or to the excipients making up sufentanil or paracetamol.
* Pregnant or breastfeeding woman.
* Patient not understanding French.
* Protected adult patient (under guardianship, curatorship or legal protection).

Primary outcomes:
measure: Total dose of sufentanil
timeFrame: 48 hours
Secondary outcomes:
measure: Total amount of opiods
timeFrame: 5 days
measure: Pain assessment
timeFrame: 5 days
measure: Delirium
timeFrame: 5 days
measure: Global Quality of life
timeFrame: 3 months
measure: Chronical pain
timeFrame: 3 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service Anesthésie Réanimation - Hôpital nord
Study officials:
affiliation: AP-HM
name: Jean Olivier ARNAUD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03381716: Correlation Between Sex and Prognosis of Acute Aortic Dissection in the Chinese Population
Official title: Correlation Between Sex and Prognosis of Acute Aortic Dissection in the Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Aortic Dissection
Sex Role
Keywords: aortic dissection
sex
treatment
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 884
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese

Brief summary: The study evaluated the prevalence, presentation, management, and prognosis of coronary heart disease differ according to sex.

Detailed description: The study included 884 patients enrolled in our institute between June 2002 and May 2016. Considering psychosocial factors, treatments, and the outcomes in men versus those in women with acute aortic dissection, explored the association of sex with psychosocial characteristics and mortality risk. Of 884 patients, 211 (23.9%) were women. The median duration of follow-up was 2.9 years (25th -75th percentiles: 1-4 years ).

Eligibility criteria: Inclusion Criteria:

* acute aortic dissection

Exclusion Criteria:

* Chronic aortic dissection

Primary outcomes:
measure: The outcome measure describes aortic disease-related death，aortic dissection, paraplegia, myocardial ischemia, renal insufficiency and other aortic complications.
timeFrame: 2.9years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bossone E, LaBounty TM, Eagle KA. Acute aortic syndromes: diagnosis and management, an update. Eur Heart J. 2018 Mar 1;39(9):739-749d. doi: 10.1093/eurheartj/ehx319.
Clinical trial NCT03679416: Is There a Benefit of Whole Body Computed Tomography (WBCT) for Patients With Only High Velocity Road Traffic Collision (RTC) Vittel Criteria?
Official title: Is There a Benefit of Whole Body Computed Tomography (WBCT) for Patients With Only High Velocity Road Traffic Collision (RTC) Vittel Criteria?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Velocity Transport Accidents
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: victims of high velocity RTC, with no other Vittel criteria of gravity, normal clinical examination of the thorax, abdomen and pelvis and Glasgow Coma Scale (GCS) score of 15.

Brief summary: For victims of high velocity RTC, with no other Vittel criteria of gravity, normal clinical examination of the thorax, abdomen and pelvis and Glasgow Coma Scale (GCS) score of 15 :

* Study of clinically unsuspected injuries discovered on WBCT
* Description
* Predictive factors
* Diagnostic performances of kinetic elements of Vittel criteria, and results of examinations realised at the ED.


Eligibility criteria: Inclusion Criteria:

Consecutives patients consulting the emergency department between August 1st 2016 and July 31th 2017 :

* Older than 18 y.o.
* WBCT performed,
* Victim of a high velocity RTC as defined by the presence of at least one criteria of the kinetics elements of the Vittel Criteria
* Normal physical exam of the chest, abdomen and pelvis,
* GCS score of 15

Exclusion Criteria:

* Opposition of the patient to the use of their CT-scan for research
* Patients who are under legal protection
* Patients who are incarcerated

Primary outcomes:
measure: Number of injuries diagnosed by Whole Body Computed Tomography (WBCT) that were not clinically suspected.
timeFrame: The day of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
References:
Clinical trial NCT03310216: The Clinical Application of Artificial Intelligent(AI) Visual Inspection System
Official title: The Clinical Application of Artificial Intelligent Visual Inspection System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ophthalmology
Keywords: artificial intelligent
visual inspection
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients are assigned to two groups: participants in group I are provided AI visual inspection system first and EDTRS later, while in Group II, the participants are provided EDTRS first and AI visual inspection system later.
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the investigators provide participants from ophthalmic clinic the AI visual inspection system and EDTRS in the purpose of seeking out a better way of visual inspection with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of AI visual inspection system and EDTRS for visual inspection.

Detailed description: Patients ≤90 years old from ophthalmic clinic are enrolled to a prospective, randomized controlled study. Patients are assigned to two groups: participants in group I are provided AI visual inspection system first and EDTRS later, while in Group II, the participants are provided EDTRS first and AI visual inspection system later. All of the visual inspection methods will be repeated two times. Investigators compare the accuracy and repeatability of the AI visual inspection system, time consuming, costs and the satisfaction level between two groups.

Eligibility criteria: Inclusion Criteria:

* Patients≤90 years old from ophthalmic clinic; Written informed consents provided

Exclusion Criteria:

* Can not cooperate with the visual inspection; Unwilling to participate in this trail

Primary outcomes:
measure: The accuracy of AI visual inspection system
timeFrame: Baseline
Secondary outcomes:
measure: The time taken of visual inspection
timeFrame: Baseline
measure: Costs of AI visual inspection system
timeFrame: Baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References:
Clinical trial NCT06427616: Moderate Intensity Soleus Pushups Versus Sustained Soleus Pushups on Blood Glucose Level Among Young Population
Official title: Effects of Short Duration Moderate Intensity Soleus Pushups Versus Sustained Soleus Pushups on Blood Glucose Level Among Young Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine that the short duration moderate intensity soleus push-ups will have a better effect on blood glucose level as compared to sustained soleus push-ups.

Detailed description: The soleus muscle is a slow oxidative muscle which possesses molecular machinery necessary for regulating blood borne substrates. It has the ability to increase the local oxidative metabolism for a long period of time without experiencing fatigue. The uniqueness lies in this muscle because of its inability to store glycogen and derives its energy directly from the glucose present in the bloodstream. This in turn helps in lowering the blood sugar by using the excess blood glucose as its primary source of fuel. The soleus muscle also stands out because of its high composition of slow oxidative fibers, around 88% of the fibers are slow twitch fibers, making it the only muscle in human body containing greater proportion of slow twitch fiber.

A specific exercise called soleus push-ups (SPU) can have a huge impact on boosting metabolism and regulating blood glucose level better than the total body muscle exercises, intermittent fasting, weight loss etc. According to the previous study it showed a significant effect on the overall blood chemistry when performed for 270 mins.

So,the purpose of this study will be to find the comparison of acute effects of sustained soleus push-ups with moderate resisted soleus push-ups on blood sugar level. To find whether moderate resisted soleus push-ups will give same or better results in short period of time.

Eligibility criteria: Inclusion Criteria:

* Age: 18-35 years.
* Gender: both male and female.
* Healthy young adults.
* BMI: healthy weight.

Exclusion Criteria:

* Patient with cardiac issues.
* Any neurological issues.
* Knee injuries.
* Patient with any lower limb injuries.
* DVT and lower amputation.
* Any known diabetic patient.

Primary outcomes:
measure: Change in Blood Sugar Level
timeFrame: Baseline to 6 hours
Secondary outcomes:
Other outcomes:
measure: Adherence to Exercise Protocol
timeFrame: Baseline to 6 hours
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University Islamabad
name: Waqar Ahmed Awan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00992316: To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects
Official title: A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Parallel Group, Dose Escalation Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Inflammatory pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 80
Sex: MALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young, healthy male volunteers

Brief summary: The purpose of the study is to investigate the safety, toleration and pharmacokinetics of single oral doses of PF-04531083 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* young
* healthy
* male

Exclusion Criteria:

* elderly
* unhealthy
* female

Primary outcomes:
measure: Safety and toleration: adverse events, supine and standing vital sign measurements,telemetry, 12-lead ECGs, blood and urine safety tests
timeFrame: up to 48 hours
measure: Plasma: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F and t½ for PF-04531083
timeFrame: 240 hours post dose
measure: Cmax, Tmax, AUClast, AUCinf and t½ for PF-04335882
timeFrame: 240 hours post dose
measure: Urine: Aet (amount excreted in urine), Aet% and CLr (for selected doses dependent on the emerging pharmacokinetic profile of PF-04531083, PF-04335882 and O-desmethyl metabolite (PF-04959926))where t = 48 hours.
timeFrame: 240 hours post dose
Secondary outcomes:
measure: No secondary endpoints.
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01132716: Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions
Official title: A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Valacyclovir Caplets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Zoster
Shingles
Genital Herpes
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to valacyclovir hydrochloride or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACs Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACs Institute, Ltd.
name: Alan Copa, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04332016: COVID-19 Biological Samples Collection
Official title: Biological Samples Collection From Patients and Caregivers Treated at Bordeaux University Hospital for Asymptomatic and Symptomatic Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Infection (COVID-19).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infection Viral
Keywords: COVID-19
SARS-CoV-2
coronavirus
biological samples
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 2000
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients / caregivers treated at Bordeaux University Hospital for asymptomatic or symptomatic infection by SARS -CoV-2.

Brief summary: The coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization.

In the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline.

The main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.


Eligibility criteria: Inclusion Criteria:

* Patients / caregivers treated at Bordeaux University Hospital for asymptomatic or symptomatic infection by SARS -CoV-2
* men and women, adults and minors as well as pregnant or breastfeeding women
* patients who died following infection with SARS-CoV-2 (specific criterion for post-mortem biopsies)
* Be affiliated with or beneficiary of a social security scheme
* Free and informed consent obtained and signed by the patient

Exclusion Criteria:

* Under guardianship or curatorship

Primary outcomes:
measure: COVID-19 desease description
timeFrame: Inclusion visit (Day 1)
measure: COVID-19 desease description
timeFrame: Day 30 to 90
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
Study officials:
References:
Clinical trial NCT00092716: Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)
Official title: A Multicenter, Double-Blind, Randomized, Parallel Group, 28-Week Study to Evaluate the Efficacy and Safety of Ezetimibe and Simvastatin Co-administration Versus Atorvastatin in Patients With Hypercholesteremia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 655
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 determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.


Eligibility criteria: Inclusion Criteria:

* Elevated cholesterol levels

Exclusion Criteria:

* Liver disease
* Unstable medical conditions

Primary outcomes:
measure: To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.
Secondary outcomes:
measure: Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C
measure: Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level
Other outcomes:
Locations:
Study officials:
References:
citation: Ballantyne CM, Blazing MA, King TR, Brady WE, Palmisano J. Efficacy and safety of ezetimibe co-administered with simvastatin compared with atorvastatin in adults with hypercholesterolemia. Am J Cardiol. 2004 Jun 15;93(12):1487-94. doi: 10.1016/j.amjcard.2004.02.060.
citation: McKenney J, Ballantyne CM, Feldman TA, Brady WE, Shah A, Davies MJ, Palmisano J, Mitchel YB. LDL-C goal attainment with ezetimibe plus simvastatin coadministration vs atorvastatin or simvastatin monotherapy in patients at high risk of CHD. MedGenMed. 2005 Jul 14;7(3):3.
citation: Catapano A, Brady WE, King TR, Palmisano J. Lipid altering-efficacy of ezetimibe co-administered with simvastatin compared with rosuvastatin: a meta-analysis of pooled data from 14 clinical trials. Curr Med Res Opin. 2005 Jul;21(7):1123-30. doi: 10.1185/030079905X50642.