louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00181246: Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Complex Regional Pain Syndromes (CRPS)
Keywords: Neuropathic pain
Efficacy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: PriCara, Unit of Ortho-McNeil, Inc.
First posted: 2005-09-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established, although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has been shown to be effective for treating other types of pain. We propose to measure functional outcomes, pain relief and side effects of fentanyl TTS for the treatment of neuropathic pain. Measures will be made at baseline and after titrating the drug to an effective level.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Neuropathic pain persisting for \> 3 months
* Pain over the immediate previous three months
* The average of the least and usual pain intensity rating of 3 or greater (0-10 numerical rating scale) during the last week prior to enrollment

Exclusion Criteria:

* A history of substance abuse
* Allergic reaction to an opioid
* Significant pain of alternate etiology other than the neuropathic pain state
* Severe pulmonary disease
* Recent myocardial infarction (within the preceding three months)
* Pregnancy
* Dementia
* Encephalopathy
* Those with life expectancy of less than six months and HIV seropositivity.

Primary outcomes:
measure: Change in pain intensity (0-10) and daily activity
Secondary outcomes:
measure: Pain relief (0-100%)
measure: Cognition (digital symbol and grooved peg-board)
measure: Impairment of function (MPI) and affect (BDI)
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Srinivasa N Raja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05377346: Effect of Paratracheal and Cricoid Pressure on the Placement of the I-gel.
Official title: A Comparison of the Effect of Paratracheal and Cricoid Pressure on the Placement of the I-gel.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paratracheal Pressure
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to compare the effect of paratracheal and cricoid pressure on placement of the i-gel in terms of the success rate of i-gel insertion, time to placement, the rate of optimal position of the device, and difficulty of i-gel placement.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* Presence of an upper airway anatomic variation or pathology
* Increased risk of pulmonary aspiration
* Known or predicted difficult airway
* Surgery requiring lateral or prone position, head and neck surgery
* Requirements for postoperative ventilator care.

Primary outcomes:
measure: The success rate of the i-gel placement
timeFrame: Immediately after the placement of the i-gel
Secondary outcomes:
measure: Time to placement of the i-gel
timeFrame: Immediately after the placement of the i-gel
measure: The rate of optimal position of the i-gel
timeFrame: Immediately after the placement of the i-gel
measure: Difficulty of the i-gel placement
timeFrame: Immediately after the placement of the i-gel
measure: Tidal volume
timeFrame: At 1 minute after the placement of the i-gel
measure: Peak inspiratory pressure
timeFrame: At 1 minute after the placement of the i-gel
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
References:
Clinical trial NCT00645346: A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age
Official title: A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Invasive Group B Streptococcus (GBS) Disease
Keywords: GBS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.


Eligibility criteria: Inclusion Criteria:

* healthy females 18 through 40 years of age;
* have provided written informed consent after the nature of the study has been explained;
* are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period);
* are in good health as determined by: medical history ,physical assessment

Exclusion Criteria:

* unwilling or unable to give written informed consent to participate in the study;
* pregnant (serum pregnancy test)
* unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization
* nursing (breastfeeding) mothers

Primary outcomes:
measure: To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine
timeFrame: 1 month
Secondary outcomes:
measure: To study the magnitude and durability of GBS-specific antibody responses over 12 months.
timeFrame: 12 months
Other outcomes:
Locations:
city: Ligornetto
country: Switzerland
facility: Institute for Pharmacokinetic and Analytical Studies I.P.A.S.
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT01622946: The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach
Official title: The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach. A Prospective, Double Blind, Placebo-controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Hip Arthroplasty
Postoperative Blood Loss
Keywords: total hip arthroplasty
tranexamic acid
postoperative blood loss
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the suction drain following a total hip replacement


Eligibility criteria: Inclusion Criteria:

* patients who will receive a unilateral total hip arthroplasty

Exclusion Criteria:

* coagulopathy
* allergy to tranexamic acid
* preoperative anemia (a hemoglobin value of \< 11g/dL in females and \< 12g/dL in males)
* fibrinolytic disorders
* a history of arterial or venous thromboembolic disease
* pregnancy
* breastfeeding
* major comorbidities

Primary outcomes:
measure: postoperative blood loss in patients undergoing primary total hip arthroplasty
timeFrame: Haemoglobin levels, on which the postopererative blood loss is calculated, is measured preoperative and on day 1 and 4 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Pellenberg
country: Belgium
facility: UZ Pellenberg
Study officials:
References:
Clinical trial NCT01776346: Barrett's Esophagus Patient Registry
Official title: Barrett's Esophagus Patient Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Barrett Esophagus
Esophageal Adenocarcinoma
Gastroesophageal Reflux
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been seen at Massachusetts General Hospital.

Brief summary: The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more effective targeted screening strategies and treatment options for Barrett's esophagus and esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a platform. Examples of analyses could include identifying genetic determinants and biomarkers that predict BE, progression of BE to EAC, as well as the response to therapies.


Eligibility criteria: Inclusion Criteria:

* Barrett's (BE): Patients who have Barrett's esophagus (all stages: Barrett's metaplasia, low-grade dysplasia, high-grade dysplasia) based upon standard endoscopic and histologic criteria.
* Adenocarcinoma (EAC): Patients who have esophageal adenocarcinoma.
* The control cohort will include patients ages 18 and older with no prior history of BE and EAC. These may include patients who are being seen or have been previously seen at MGH GI Associates for conditions including gastroesophageal reflux disease, peptic esophagitis, eosinophilic esophagitis, esophageal motility disorders such as achalasia and nutcracker esophagus.

Exclusion Criteria:

* Inability or unwillingness to provide blood samples.
* History of known bleeding disorders.
* Currently awaiting organ transplantation.
* Having an acute or severe chronic illness such as congestive heart failure or any other condition that would prohibit performing the endoscopy.

Primary outcomes:
measure: Progression to esophageal adenocarcinoma
timeFrame: 5 years (on average although follow-up will continue)
Secondary outcomes:
measure: Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy
timeFrame: 5 years on average
measure: Evaluate the natural history of BE with and without treatment based on clinical, functional and economic outcomes of the cases
timeFrame: 5 years on average
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT05831046: Emergency Department Re-evaluation Software Pilot Study
Official title: Pilot Study for Patient Re-evaluation Software to Improve Emergency Department Waiting Room Congestion
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Emergency Department Waiting Room Congestion
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a research study to determine a method in improving emergency department waiting room care by using new software program.

Detailed description: This is a pilot study to determine the effectiveness of an emergency department re-evaluation software, to improve patient flow through an emergency department. The end goal of the study is to provide proof of the efficacy of the software and provide data such that the software can be improved upon. The study will include ED waiting room patients. The study will involve interaction with the software on a tablet for patients and software on a desktop for providers. The providers utilizing the software will not be considered part of the study, but rather focusing on the outcomes of the patients using the software. Patients will be selected by the provider as available for re-evaluation. Each patient will then be randomized into either a control group (software not used) and a "study" group (software used). Data analysis will be performed in conjunction with clinical statisticians at our institution. The risks of this study are primarily derived from patient privacy concerns, which have been addressed in the risk section.

Eligibility criteria: Inclusion:

* Individuals that are 18 and older who have been identified with completed lab work.
* Their primary language must be English to follow the instructions of the study.
* Cognitively sound

Exclusion:

* Minors
* Emergency Severity Index (ESI) class 1 patients
* Individual who cannot legally give consent
* Pregnant patients
* Non-english speakers

Primary outcomes:
measure: Change in LBTC (left before treatment complete) rates
timeFrame: Baseline, up to 1 year
Secondary outcomes:
measure: Change in disposition time
timeFrame: Baseline, up to 1 year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital Emergency Department
state: North Carolina
Study officials:
affiliation: Duke Health
name: Lauren Siewny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06786546: Type 1 Diabetes Autonomic and Vascular Function
Official title: Autonomic Control and Vascular Function in Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Type 1 Diabetes (Juvenile Onset)
Type 1 Diabetes
Diabetes, Autoimmune
Keywords: autonomic function
exercise pressor reflex
muscle sympathetic nerve activity
Reactive hyperemia
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Dell Medical School at The University of Texas at Austin
First posted: 2025-01-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 1 Diabetes

Brief summary: The goal of this clinical trial is to investigate the autonomic and vascular function in men and women with Type 1 diabetes. The main questions it aims to answer are:

1. Patients with type 1 diabetes exhibit attenuated vascular function during steady-state exercise
2. Patients with type 1 diabetes have altered autonomic function at rest and during exercise pressor reflex
3. Patients with type 1 diabetes have attenuated muscle sympathetic activity

Detailed description: Elevated blood glucose levels in individuals with type 1 diabetes can result in both microvascular and macrovascular complications. Research conducted by Song et al. revealed that children with type 1 diabetes exhibit abnormal cerebral perfusion. Additionally, autonomic mechanisms are affected in type 1 diabetes, as indicated in an animal study which demonstrated that the exercise pressor reflex is exaggerated in both male and female rats during the early stages of the disease. However, whether this also occurs in human patients with type 1 diabetes remains unknown.

Therefore, in this study we are interested in studying the autonomic control of exercise and vascular function in T1DM humans.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes or a Healthy control

Exclusion Criteria:

* BMI \> 40kg/m2
* Cancer with current treatment
* HIV
* Smoker cigarettes
* Are pregnant or breastfeeding

Primary outcomes:
measure: Vascular Function
timeFrame: Blood flow will be measured at baseline for 5 min in supine position. During exercise, blood flow will be measured continuously for the 3 minutes of handgrip exercise.
measure: Autonomic Function
timeFrame: Blood presure will be measured at baseline for 10 minutes and continuously during 2 minutes of isometric handgrip.
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT00724269: Comparison of OPTI-FREE RepleniSH and ReNu Multi-Plus Lens Care Regimens on Corneal Epithelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wear
Keywords: Contact lens wear
multi-purpose solution
corneal staining
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The purpose of this study is to evaluate the corneal epithelium after soft contact lens wear and use of two marketed multi-purpose solutions.


Eligibility criteria: Inclusion Criteria:

* Successful contact lens wear on a daily wear basis
* Wear contact lenses at least 8 hours/day
* Vision correctable to at least 20/30
* Normal Eyes
* Other protocol-defined inclusion criteria may apply

Exclusion:

* Topical ocular medication use
* Other protocol-defined inclusion criteria may apply

Primary outcomes:
measure: Confocal microscopy analysis of Corneal Epithelium
timeFrame: 2 weeks
Secondary outcomes:
measure: Patient comfort
timeFrame: 2 weeks
measure: Corneal Staining
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Study Locations
state: Texas
Study officials:
References:
Clinical trial NCT03062969: The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies
Official title: The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Preimplantation Genetic Screening
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 383
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a PGS cycle with own gametes for any of the following indications: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies.

Brief summary: Shortly after the implementation of Comprehensive Chromosome Screening (CCS) techniques for Preimplantation Genetic Screening (PGS) came the transition in biopsy timing. Trophectoderm biopsy is meant to overcome the limitations of cleavage stage biopsy and single cell analysis.

Detailed description: The investigators have recently introduced this new approach and a frozen-thawed policy of euploid blastocysts is routinely performed.

This is a single centre retrospective study in patients undergoing a PGS cycle. The aim of the study is to assess the results obtained in a PGS programme after the implementation of a new biopsy timing and transfer policy. Results obtained in PGS cycles with blastocyst biopsy and frozen-thawed embryo transfer were analysed in comparison to cycles with cleavage stage biopsy and fresh blastocyst transfer.

Eligibility criteria: Inclusion Criteria:

* Own gametes
* PGS for: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies

Exclusion Criteria:

* PGS cycles with gamete donation
* Altered karyotypes
* Combined Preimplantation genetic diagnosis (PGD)+PGS cycles

Primary outcomes:
measure: Ongoing clinical pregnancy rate
timeFrame: 20 weeks after embryo transfer
Secondary outcomes:
measure: Implantation Rate
timeFrame: 6 weeks after embryo transfer
measure: Number of available euploid blastocysts per cycle
timeFrame: Up to 15 days after embryo biopsy
measure: Miscarriage Rate
timeFrame: Until 20 weeks after embryo transfer
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02484469: Impact of the Virtual Human Project on Team-based Learning: A Randomized-controlled Trial
Official title: Educational Virtual Objects (The Virtual Human Project) Assessment Inserted in Learning Based on Team (Team-based Learning) in Leprosy Education on Undergraduate Medical Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leprosy
Lead sponsor: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Sponsor class: OTHER_GOV
First posted: 2015-06-29
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Team-based learning (TBL) is a learner-centered, instructor-directed strategy for small group active learning in large group educational settings. When TBL is conducted correctly, the students' performances are equivalent or improved in comparison to either lecture-based formats or more traditional small group learning models.1 Nevertheless, few studies have been published regarding the insertion of innovative audiovisual tools in the TBL context. The Virtual Human Project is described as powerful sequences of three dimension (3D) computer graphics video of the human body that aids learning by facilitating an understanding in relation to a specific subject. The Virtual Human is composed by video sequences combining anatomy, physiology, and morphology in the context of various diseases. There are video sequences available for many disciplines, including dermatology and with capacity to produce anatomical structures by 3D printer. Despite the incredible potential applications of the Virtual Human, few studies have assessed its impact on medical education. The investigators did not find any study evaluating TBL with the insertion of iconographic educational material that assessed whether this intervention could change the learning progress of students. This is the aim of the present study, by comparing students tests scores after a TBL session with the VIrtual Human videos about leprosy or a standard TBL session, and to evaluate the student's satisfaction with the Virtual Human videos.


Eligibility criteria: Inclusion Criteria:

* undergraduate medical students in the third year of Medical School at the Federal University of Mato Grosso do Sul.

Exclusion Criteria:

* students previously exposed to dermatologic research, extracurricular activities involving dermatology or dermatology rotation in that year

Primary outcomes:
measure: Average of Individual readiness assessment test (IRAT) grades
timeFrame: One year
Secondary outcomes:
measure: The Average of group readiness assessment test (GRAT) grades
timeFrame: One year
measure: The Average of clinical case scores
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References: