louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03001843: Ketamine vs Hydromorphone
Official title: Does a Ketamine Infusion Decrease Post Operative Narcotic Consumption After Gastric Bypass Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Gastric Bypass
Obesity
Pain, Postoperative
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 54
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: OTHER

Brief summary: This study will help to determine if investigators can minimize narcotic use in laparoscopic gastric bypass patients while maintaining adequate pain control. This will allow investigators to minimize the negative side effects of narcotics which is a goal in this population.

Detailed description: The study will be a head to head observational study of patients who have undergone gastric bypass surgery. The methods of intraoperative anesthesiology will be Ketamine or Narcotic. Both are FDA approved methods of delivering anesthesia.

The amount of narcotics a patient receives is part of the medical record post-operatively will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of narcotics needed to control the patient's pain (converted to morphine equivalent units) and pain scores (a hospital standard measure) will be collected for 48 hours for the study, or until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows investigators to compare different narcotics the patient may receive in a more standardized way. The results will be analyzed and compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of age

Exclusion Criteria:

* Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.

Primary outcomes:
measure: Pain Measured Based on Pain Medication Used on a Scale of 0-10
timeFrame: 48 hours
Secondary outcomes:
measure: Length of Stay (Hours)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: Shands Hospital at the University of Florida
name: David M Smyth, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02241343: Venous Occlusion and Limb Swelling
Official title: Venous Occlusion and Limb Swelling
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Venous Occlusion
Keywords: Venous occlusion
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Problems affecting the veins in the legs can cause discomfort and swelling. We want to see how artificially and reversibly blocking the leg veins affects swelling in the lower limb.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old, able to consent

Exclusion Criteria:

* History of cardiovascular/renal disease

Primary outcomes:
measure: Leg Swelling
timeFrame: 30 minutes
Secondary outcomes:
measure: Venous Diameter
timeFrame: 30 minutes
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: Alun Davies
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01153243: Vitamin D and Inflammatory Markers of Cardiovascular Disease in African Americans With Type 2 Diabetes
Official title: Does Administration of Vitamin D in African Americans With Hypovitaminosis D and Type 2 DM Improve Inflammatory Markers of Cardiovascular Disease?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vitamin D Deficiency
Diabetes
Keywords: inflammatory markers
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
Collaborators: name: Rush University
First posted: 2010-06-30
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent clinical trials in non diabetics showed that vitamin D supplementation markedly reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix metallo-proteinases. Our study objective is to evaluate if administration of vitamin D in African Americans with hypovitaminosis D and DM Type 2 decreases serum levels of inflammatory/thrombotic markers such as CRP: Highly Sensitive C Reactive Protein.

Detailed description: Other questions in our study: In diabetic African American patients,

1. Prevalence of vitamin D deficiency?
2. Correlation/relationship between vitamin D levels, Calcium level, parathyroid hormone (PTH) and Inflammatory markers

Setting: All visits will take place at the Fantus Diabetes Clinic.

Eligibility criteria: Inclusion Criteria:

* African Americans
* DM type 2

Exclusion Criteria:

* symptomatic vitamin D deficiency
* hypocalcemia
* hypercalcemia
* malabsorption
* liver disease
* patients with creatinine \> 1.5. (CKD \>/= 3)
* pregnancy

Primary outcomes:
measure: Levels of inflammatory markers
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Levels of Vitamin D, PTH and Calcium
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Cook County Health
name: Leon Fogelfeld, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04656743: Comparison of Genicular Nerve Block and Intraarticular Injection for Postoperative Pain in Knee Arthroscopy
Official title: Comparison of Genicular Nerve Block and Intraarticular Injection for Postoperative Pain in Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 66
Sex: ALL
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: This prospective double-blinded randomized study will be conducted to compare ultrasound-guided intra-articular injection and ultrasound-guided genicular nerve block for postoperative analgesia after knee arthroscopy.

Detailed description: Arthroscopic knee surgery has become increasingly popular in modern orthopedics. Post-operative knee pain management has become a challenge to provide early relief and pain-free postoperative care to the patient.

Pain management has become a priority for management as a daycare procedure. Patients operated as a daycare procedure should have minimal postoperative pain which influences the timing of discharge. Pain is due to multifactorial causes such as irritation of free nerve endings of the joint capsule, synovial tissue, anterior fat pad.

Effective pain relief allows the patients to obtain early knee mobilization and optimal rehabilitation and thus improves patient satisfaction.

Postoperative pain after knee arthroscopy is commonly moderate to severe and can affect the patient's activity level and satisfaction.

In an effort to provide safe, effective, and long-lasting post-arthroscopy pain relief, many drug regimens were injected intra-articularly including local anesthetics alone or with additive drugs to prolong and improve the quality of postoperative analgesia.

Genicular nerve block (GNB) and ablation have been used for managing chronic pain from knee osteoarthritis with good success.

Eligibility criteria: Inclusion Criteria:

* scheduled for unilateral knee arthroscopy surgery (ligament reconstruction, cartilage procedures, and diagnostic arthroscopic procedures)
* aged between 18 and 50 years
* of both genders,
* have ASA physical status I and II.

Exclusion Criteria:

* Revision knee arthroscopy,
* previous surgery or trauma to the knee,
* drug allergy,
* regular narcotic use,
* renal \&/ or hepatic impairments,
* neuromuscular diseases
* and coagulopathy disorders.

Primary outcomes:
measure: first time of rescue analgesia
timeFrame: postoperative first day
Secondary outcomes:
measure: Number of patients received rescue analgesia.
timeFrame: postoperative first day
measure: Total doses of postoperative morphine consumption
timeFrame: postoperative first day
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tarek Abdel Hay
state: El Gharbyia
Study officials:
References:
Clinical trial NCT00823043: A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs
Official title: A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With Timolol Hemihydrate 0.5% Solution Once or Twice Daily Versus Timolol Maleate in Sorbate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Vistakon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-01-15
Enrollment: 103
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be performed in centers in the United States with substantial populations of patients prescribed timolol hemihydrate and timilol maleate in sorbate.

Brief summary: The objective of the study was to evaluate whether timolol hemihydrate is more comfortable upon instillation than timolol maleate in sorbate. This was an observational study. Subjects with open-angle glaucoma or ocular hypertension were asked to complete a survey regarding their normal treatment. No treatment was prescribed.


Eligibility criteria: Inclusion Criteria:

* willing to comply with investigator's and protocol's instructions
* patients signature on the informed consent document
* open-angle glaucoma or ocular hypertension
* currently prescribed timolol hemihydrate (once a day (QD) or twice a day (BID))or timolol maleate in sorbate QD as monotherapy or as a part of 2-drug therapy in at least one eye

Exclusion Criteria:

* inability to understand the trial procedures
* inability to give informed consent
* inability to understand, read, or write English
* best corrected visual acuity of 20/200 or worse in each eye
* current moderate to severe infectious or inflammatory condition of the eye or eyelids including
* current moderate to severe dry eye syndrome
* current chronic use of ocular corticosteroids, ocular surgery or intraocular laser surgery to either eye in the prior 3 months
* treated with 3 or more glaucoma medicines in both eye

Primary outcomes:
measure: Subject Reported Burning/Stinging
timeFrame: Upon instillation
measure: Subject Reported Tearing
timeFrame: Upon instillation.
measure: Subject Reported Light Sensitivity
timeFrame: Upon instillation
measure: Subject Reported Blurred Vision
timeFrame: Upon instillation
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Eye Care of San Diego
state: California
Study officials:
affiliation: PRN Pharmacuetical Research Network, LLC
name: William C. Stewart, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03025243: The Effect of Printing Layer Thickness on the Accuracy of Computer Aided Surgical Guides
Official title: The Effect of Printing Layer Thickness on the Accuracy of Computer Aided Surgical Guides : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Guided Surgery
Keywords: computer aided design , dental implants , accuracy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of printing layer thickness on accuracy of computer aided surgical guide

Detailed description: Computer aided surgical guide has many variables that affect its accuracy , in this study one variable is considered that may affect the accuracy of surgical guide which is printing of layer thickness of surgical guide whether 50 micron or 100 micron.

computer aided surgical guide is constructed by imaging the patient pre-operative cone beam CT wearing scan appliance , then virtual implant placement on special soft ware ( Blue sky Bio ) and optical scanning of patient casts , afterword superimposition of the virtual implants on the scanned casts to design the surgical guide and printing on 3D printer ( Zenith 3D printer , Dentis , Korea ) with printing layer thickness 50 micron in first group and 100 micron in second group . Fixation of surgical guide in patient mouth and drilling of implant osteotomy through the guiding sleeves , post-operative Cone Beam CT with the same apparatus and setting as pre-operative scan .

Finally, the pre-operative and post operative scans were then overlapped to measure linear and angular deviation of the virtually planned and actual implants position.

Eligibility criteria: Inclusion Criteria:

* patients partially or totally edentulous arches .
* patients with Bucco-lingual bone thickness \>6 mm allowing flapless implant placement
* patients free from any systemic diseases that may affect bone quality e.g diabetes .

Exclusion Criteria:

* patients with thin ridges.
* patients with systemic disease that may affect bone quality.
* Patients with poor oral hygiene and active periodontal diseases.
* Anatomical situations requiring regenerative procedure.

Primary outcomes:
measure: accuracy of surgical guide
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mahmoud El far, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01951443: Korean Red Ginseng Rg3 Extract on Arterial Stiffness and Blood Pressure
Official title: Acute Effect of Rg3-enriched Korean Red Ginseng (Steamed Panax Ginseng C.A. Meyer) Standardized Extract on Arterial Stiffness and Aortic and Brachial Blood Pressure in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arterial Stiffness, Blood Pressure
Keywords: ginseng
clinical trial
vascular
ginsenosides
blood pressure
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the acute effect of a standardized extract of KRG (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial stiffness and blood pressure, as measured by the following parameters: aortic augmentation index, peripheral blood pressure, central blood pressure


Eligibility criteria: Inclusion Criteria:

* Healthy
* Age 18-70 years
* BMI \< 30 kg/m2
* Brachial systolic blood pressure \< 140 mmHg
* Brachial diastolic blood pressure \< 90 mmHg

Main Exclusion Criteria:

* BMI \>30kg/m2
* Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg)
* Pregnancy

Primary outcomes:
measure: To evaluate the acute effect of Rg3-KRG on arterial stiffness in healthy adult volunteers, as measured by aortic augmentation index (AIx).
timeFrame: Two weeks (measurements taken on two separate visits with minimum one week washout)
Secondary outcomes:
measure: To evaluate the acute effect of Rg3-KRG on aortic and brachial blood pressure in healthy adult volunteers.
timeFrame: Two weeks (measurements taken on two separate visits with minimum one week washout)
Other outcomes:
measure: To evaluate the acute safety of Rg3-KRG in healthy adult volunteers using a 48hr symptoms questionnaire.
timeFrame: Two weeks
Locations:
city: Toronto
country: Canada
facility: Risk Factor Modification Centre, St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Risk Factor Modification Centre - St. Michael's Hospital
name: Dr. Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Dr. Amir Hanna (Qualified investigator), MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01476943: Patterns of Use of Belatacept: Analysis of Data From the Collaborative Transplant Study
Official title: Belatacept in Renal Transplantation: Patterns of Use Analysis Using the Collaborative Transplant Study (CTS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplantation, Organ
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Heidelberg University
First posted: 2011-11-22
Enrollment: 72392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with Belatacept or a CNI based regimen at the time of transplantation

Brief summary: The primary purpose is to describe the pattern of Belatacept use at the time of transplant and up to three years post-transplantation for all Belatacept treated patients.

Detailed description: Time Perspective: Prospective design, Retrospective data collection and analysis

Eligibility criteria: Inclusion Criteria:

* Patients who received solid organ transplantation during study period in one of the transplant centers involved in CTS

Primary outcomes:
measure: The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by Cytomegalovirus (CMV) serostatus
timeFrame: At the time of transplantation
measure: The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
timeFrame: 1 year post transplantation
measure: The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
timeFrame: 2 year post transplantation
measure: The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
timeFrame: 3 year post transplantation
Secondary outcomes:
measure: Extent of switches to or from Belatacept within three years post transplantation, and the temporal trend in switches post regulatory approval of Belatacept
timeFrame: At transplantation, 12 month, 24 month and 36 month post transplantation
measure: Characteristics of Belatacept users vs. Calcineurin inhibitor (CNIs) users at transplantation
timeFrame: At the time of transplantation
measure: Characteristics of those who switch to or from Belatacept vs. those who do not switch one year post-transplant
timeFrame: At transplantation and 12 month post transplantation
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00373243: A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment
Official title: An Open-label, Non-randomised Study of 20 mg GW406381 Single Dose Pharmacokinetics in Healthy Subjects and in Volunteers With Moderate Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: hepatic impairment pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in subjects with moderate hepatic impairment in comparison to matched healthy volunteers. The hepatically impaired and healthy groups will be given a single 20 mg oral dose of GW406381. Blood samples for PK analysis will be collected pre-dose and over the 72 hours post dosing. Subjects will be housed from the evening before dosing until 24 hours after dosing. A follow-up visit will be conducted between 7 to 10 days from the last dose of study drug.


Eligibility criteria: Inclusion criteria:

* Healthy subjects or subjects with moderate hepatic impairment as defined by a Child-Pugh score of 7-9
* Body weight less = 100 kg
* Body mass index (BMI) within range of 19 - 32 32kg/m2

Exclusion criteria:

* Presence of any other significant disease
* Use of any medication within the 2 weeks prior to dosing, unless approved by both the investigator and GSK personnel

Primary outcomes:
measure: GW406381 pharmacokinetic parameters AUC and Cmax
timeFrame: throughout the study
Secondary outcomes:
measure: GW406381 pharmacokinetic parameters Tmax, Total plasma clearance, and if data permits the t1/2 of GW406381 GW404347 pharmacokinetic parameters AUC and Cmax Ex vivo protein binding Clinical laboratory values, adverse events, vital signs and 12 lead ECG
timeFrame: throughout the study
Other outcomes:
Locations:
city: Balantonfured
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: