louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00373854: Study of How Low Blood Sugar Affects the Way Blood Vessels Work
Official title: Hypoglycemia and Endothelial Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoglycemia
Keywords: Hypoglycemia
Endothelial function
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: Hypothesis: Low blood sugar (hypoglycemia) decreases function of the lining of the blood vessels in normal humans.

This study is designed to explore how hypoglycemia affects the function of the blood vessel lining. This will be determined by measuring blood flow to the arm before and after occlusion of flow. Blood vessel function will be measured before induction of hypoglycemia, during insulin induced hypoglycemia, and after recovery from hypoglycemia. A second study will be done but without hypoglycemia.

Detailed description: Purpose: The purpose of the research is to learn more about how low blood sugar (low blood glucose or hypoglycemia) affects the way the blood vessels work in healthy people. Subjects who participate in this research project must be in good health and taking no medications.

Methods: A screening visit to the Clinical Research Center of the Ohio State University will be used to assess eligibility to participate. The main study consists of two visits to the Clinical Research Center that occur two to four weeks apart. Each of these visits will involve a procedure known as an insulin clamp. This involves giving insulin and sugar water into a vein. The amount of sugar given varies to keep the blood sugar at a predetermined level. For one of the two visits the blood sugar will be low and the other it will be normal. The function of the blood vessels will be measured three times during each study by measuring blood flow before and after stopping blood flow to the arm for 5 min.

Eligibility criteria: Inclusion Criteria:

* Age 18-40 years
* BMI \<27 kg/m2

Exclusion Criteria:

* Pregnancy
* Systolic blood pressure \>140 mmHg
* Diastolic Blood pressure \>90 mg/dl
* Spot daytime urine microalbumin concentration \> 20 μg/mg creatinine
* Past or present history of chronic disease (e.g. cancer, hypertension, cardiovascular disease, chronic inflammatory disease) other than diabetes in type 1 diabetic subjects.
* Use of non prescription medications in the past 3 days
* Use of prescription medications in the past 2 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Robert P Hoffman, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00544154: Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis
Official title: Efficacy and Safety of CDP870 400 mg in Combination With Methotrexate Compared to Methotrexate Alone in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Are Partial Responders to Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: CDP870
Certolizumab pegol
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 247
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 main purpose of the study was to determine the efficacy of CDP870 in treating RA signs/symptoms in patients who were partial responders to MTX. Other purposes were to show additional efficacy without increased toxicity and the immunogenic response to CDP870 during combined CDP870 and MTX therapy.


Eligibility criteria: Inclusion Criteria:

* male/female, 18-75 years old, inclusive
* diagnosis of adult-onset RA
* had active disease
* had received methotrexate
* on a stable dose of folic acid

Exclusion Criteria:

* contraindication for methotrexate or anti-TNF

Primary outcomes:
measure: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
Secondary outcomes:
measure: Safety and tolerability
measure: health outcomes measures
measure: immunogenic profile of CDP870 plus methotrexate
measure: systemic exposure of CDP870
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Choy E, McKenna F, Vencovsky J, Valente R, Goel N, Vanlunen B, Davies O, Stahl HD, Alten R. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford). 2012 Jul;51(7):1226-34. doi: 10.1093/rheumatology/ker519. Epub 2012 Feb 16.
Clinical trial NCT02004054: Interest of Dynamic Measures of the Pupil in Optic Neuritis
Official title: Interest of Dynamic Measures of the Pupil in Optic Neuritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Neuritis
Keywords: multiple sclerosis
diameter pupil
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2013-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with unilateral optic neuritis or with multiple sclerosis and an optic neuritis in the previous 5 years

Brief summary: The investigators' hypothesis is that measuring the PCTdynamics would be an easy and reliable symptom to evaluate in pathologies affecting the optic nerve

Detailed description: Physiopathologic study aiming to assess the interest of measuring the lenght of pupil cycle in the dynamic study of the pupillary light reflex.

Eligibility criteria: Inclusion Criteria:

* patients with unilateral optic neuritis or with multiple sclerosis and an optic neuritis in the previous 5 years

Exclusion Criteria:

* previous history of ophthalmic and neurologic pathology
* anisocoria
* minor
* Patient with a measure of legal protection
* Pregnancy
* patient opposition to participation in the study
* no affiliation to social security

Primary outcomes:
measure: Comparison between the PCT frequency of the eye affected by optic neuritis and a sane eye
timeFrame: after 1h
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Cédric Lamirel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06637033: The Impact of Chewing Food on Stroke Patients
Official title: The Impact of Chewing Food on Stroke Patients With Dysphagia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Buraidah Central Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to explore the effect of Chewing Food on quality of life and nutritional status in ischemic stroke patients. Patients will be randomly divided into an interventional group and a control group, all receiving routine rehabilitation treatment and enteral nutrition feeding. On this basis, the interventional group will receive Chewing Food training before each feeding for 10 min. Researchers will compare changes in quality of life, and nutritional status of two groups of patients before and after the study to see if Chewing Food can improve the quality of life and nutritional status in ischemic stroke patients.

Detailed description: The study will last 15 days for each participant. The goal of this clinical trial is to explore the effect of Chewing Food on quality of life and nutritional status in ischemic stroke patients. Patients will be randomly divided into an interventional group and a control group, all receiving routine rehabilitation treatment and enteral nutrition feeding. On this basis, the interventional group will receive Chewing Food training before each feeding for 10 min. Researchers will compare changes in quality of life, and nutritional status of two groups of patients before and after the study to see if Chewing Food can improve the quality of life and nutritional status in ischemic stroke patients.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by Videofluoroscopic Swallowing Study.
* Clear consciousness.
* No history of prior stroke.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.

Primary outcomes:
measure: Dysphagia Handicap Index
timeFrame: Day 1 and day 15
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01043133: Study of Medical Student Use of Templates to Document Outpatient Asthma Care in Electronic Medical Record
Official title: Social Marketing in Medical Education: Influencing Medical Student Use of Evidence-based Templates in Outpatient Documentation of Asthma Care Using an Electronic Medical Record
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disease
Keywords: electronic medical records
documentation templates
clinical encounter notes
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
First posted: 2010-01-06
Enrollment: 155
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: The purpose of the study is to measure the effectiveness of a social marketing-based medical education intervention on student use of evidence-based templates for documenting outpatient asthma care within an electronic medical record.

Detailed description: The purpose of the study was to measure the effectiveness of a physician-educator led clinical documentation workshop, embedded with 7 persuasive social-marketing based messages, on medical student response using a targeted asthma template. Stated differently, whether a physician-educator could "persuade" medical students to use an evidence-based EMR asthma template to document an outpatient mild persistent asthma encounter with a patient.

Eligibility criteria: Inclusion Criteria:

* Third year medical student completing family medicine clerkship Uniformed Services University

Exclusion Criteria:

* All students other than those listed above

Primary outcomes:
measure: Number of Participants Using Evidence-based Template to Document Asthma Care Within an Electronic Medical Record
timeFrame: immediately after invervention and 30+ days in follow-up
Secondary outcomes:
measure: Clinical Note Completeness Score
timeFrame: immediately after intervention and 30+ days in follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Mark B. Stephens, MD, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01747733: Assessment of Sedation During Endoscopy
Official title: Assessment of Sedation During Endoscopy, a Prospective Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedation
Keywords: Endoscopy
ERCP
PCS
Sedation
Bispectral index
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing endoscopic procedures requiring anaesthesist administered sedation in the endoscopy unit in HUCH

Brief summary: Use of sedation is often required in endoscopic procedures such as ERCP (endoscopic retrograde cholangiopancreatography). However, assessment of the level of sedation during these procedures is not investigated in detail.

The purpose of this study is to compare different sedation scales and bispectral index during sedation in endoscopic procedures in order to find the best suited assessment method for sedation under these conditions.


Eligibility criteria: Inclusion Criteria:

All patients undergoing endoscopic procedure in the endoscopy unit in HUCH

Exclusion Criteria:

Primary outcomes:
measure: level of sedation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Jarno Jokelainen', M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005.
Clinical trial NCT05222633: Anti-VEGF in Real-world
Official title: Observation of Anti-vascular Endothelial Growth Factor Therapy in Exudative Age-related Macular Degeneration, Proliferative Diabetic Retinopathy, Macular Edema, and Choroidal Neovascularization.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neovascular Age-related Macular Edema
Diabetic Macular Edema
Choroidal Neovascular Membrane
Non-proliferative Diabetic Retinopathy
Retinal Vein Occlusion
Proliferative Diabetic Retinopathy
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.

Brief summary: Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-vascular endothelial growth factor therapy drugs. In the current study, the primary aim is to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.

Detailed description: Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases, including neovascular age-related macular edema, diabetic macula edema/non-proliferative diabetic retinopathy / proliferative diabetic retinopathy, retinal vein occlusions related macular edema, and choroidal neovascularization secondary to multiple retinal diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-VEGF drugs. In the current study, the primary aim is to aim to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.

Eligibility criteria: Inclusion Criteria:

* Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.
* Undergo intravitreal anti-VEGF therapy

Exclusion Criteria:

* unable to receive OCT examination
* Severe corneal opacity, cataract that affect OCT examination

Primary outcomes:
measure: Visual acuity
timeFrame: 1 year
measure: Central subfield thickness
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wen-Bin Wei
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Wenbin Wei, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03168633: Lifestyle Advises Sent Via Email in Attempt of Improving A1C in DM2 Patients
Official title: Effects of Reading Information Sent Via Email and Glycemic Control and Compliance to Recommendations Among Patients With Type 2 Diabetes Mellitus -Prospective Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: : Type 2 Diabetes Mellitus
Web-based intervention
medication adherence
lifestyle changes
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Diabetic patients need to manage their glucose level, physical activity and food intake to successfully cope with their disease. Previous work has shown that reminders of the disease, be they informational or about ones' condition, can improve management of disease in diabetes.

This trial focuses on delivering these reminders, via email, in attempt to improve the patients glycemic control (measured in Hemoglobin A1C)

Detailed description: The study initially included 50 patients (men and women, over 18 years of age) who were prior diagnosed with DM2 and unbalanced in their glycemic values (HbA1c above 7%). The patient were sent via email , once every other week, a link to web-based pages which provides information on changing DM2 related such as general DM2 information, the importance of keeping a well-balanced diet, benefits of exercising regularly, drug related information and more.

Furthermore, the patients were sent a questionnaire every other week which they were asked to actively reply to.

Each participating patient was monitored for 6 months, during this time he/she was sent 12 web-based information pages.

During the course of the study, information regarding the patients' glycemic control (in the form of HgA1c levels) was collected.

Additional variables (age, sex, BMI, time passed since diagnosed with DM2) were collected and used for statistical comparison.

Eligibility criteria: Inclusion Criteria:

1. Previous diabetes specialist follow
2. Age over 18.
3. Diagnosis of diabetes type 2.
4. HbA1c over 7%
5. Self-admitted less than optimal adherence to physical activity, diet or medications or computer-recorded less than 80% adherence to medication purchase.
6. Able to read Hebrew
7. Uses Email account that is actively read at least twice weekly.

Exclusion Criteria:

* Patients who did not the inclusion criteria

Primary outcomes:
measure: HbA1C values of patients after 6 months
timeFrame: 6 months follow up
Secondary outcomes:
measure: percentage of messages opened and read
timeFrame: 10-12 messages in 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Hospital
name: Irit Hochberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02564133: Hip Fracture and Patent Foramen Ovale
Official title: Are Postoperative Complications More Frequent When Patients Having a Hip Fracture Have a Patent Foramen Ovale ?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Fractures
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of a hip prosthesis may be complicated by intracardiac embolization of various origin.

A patent foramen ovale exists in approximately one fifth of the population; it facilitates the passage of embolus from the right heart to the left one and then especially to the coronary vessels and to the brain.

The hypothesis supported in this research is that the prevalence of postoperative complications, especially neurological ones, is increased after surgery for hip fracture when patients have a patent foramen ovale.


Eligibility criteria: Inclusion Criteria:

* hip fracture requiring a surgical procedure

Exclusion Criteria:

* simultaneous other traumatic lesion

Primary outcomes:
measure: Number of participants with postoperative complications probably related to the presence of a patent foramen ovale
timeFrame: First postoperative week
Secondary outcomes:
measure: Number of participants with postoperative complications probably not related to the presence of a patent foramen ovale
timeFrame: First postoperative week
measure: Number of days before walking without help
timeFrame: One year
measure: Number of days at home during the first postoperative year
timeFrame: one year
measure: Mortality
timeFrame: Three months and one year
Other outcomes:
Locations:
city: Levallois-Perret
country: France
facility: Institut Hospitalier Franco-Britannique
city: Rennes
country: France
facility: CHU
Study officials:
References:
Clinical trial NCT00774033: Epidermal Cells Delivery and Acute Burns
Official title: A Randomized Trial Comparing Recell® Autologous Epidermal Cells Harvesting Kits Versus Classic Skin Grafts for the Treatment of Acute Burn in Adults and Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Burn
Keywords: Keratinocytes
Cell spray
Deep partial thickness burns
Full thickness burns
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns

Detailed description: Comparing the impact in terms of cicatrisation duration and costs between 2 treatments of deep 2nd and 3rd degree burns.

Determine if the costs of the innovating treatment RECELL®, a priori more expensive, are counterbalanced by a shorter cicatrisation duration and an improved evolution versus a conventional strategy.

Give an information about efficiency improvement of RECELL® with additional costs

Eligibility criteria: Inclusion Criteria:

* Thermal burns requiring surgical debridement
* Area involved \< 1260cm²

Exclusion Criteria:

* local or systemic infection
* conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)
* hypersensitivity to trypsin

Primary outcomes:
measure: 80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.
timeFrame: at 1, 2 and 6 weeks
Secondary outcomes:
measure: Medical costs at complete epithelialisation
timeFrame: At 6, 12 and 18 months
measure: Post-operative pain
timeFrame: At 6 weeks
measure: Medical assessment of scar quality
timeFrame: at 6 weeks and 6, 12, 18 months
measure: Patient self assessment of scar
timeFrame: At 6, 12 and 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Trousseau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier GALL, PH
role: PRINCIPAL_INVESTIGATOR
References: