louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04799015: Dexamethasone for Post Traumatic Headache
Official title: A Randomized Study of Dexamethasone as Adjuvant Therapy for Acute Post-traumatic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Traumatic Headache
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 162
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.


Eligibility criteria: Inclusion Criteria:

Meet International Classification of Headache Disorders criteria for acute post-traumatic headache as follows:

* Traumatic injury to the head has occurred
* Headache has developed within 7 days of injury to the head
* Headache is not better accounted for by another diagnosis (e.g., migraine or tension-type headache)
* The headache must be rated as moderate or severe in intensity at the time of initial evaluation

Exclusion Criteria:

* More than ten days have elapsed since the head trauma
* Headache has already been treated with an anti-dopaminergic medication
* Medication allergies
* Contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications

Primary outcomes:
measure: Frequency Moderate or Severe headache after Emergency Department (ED) discharge
timeFrame: Up to 48 hours after ED discharge
Secondary outcomes:
measure: Sustained headache relief
timeFrame: 48 hours after ED discharge
measure: Post concussive symptoms
timeFrame: 48 hours after ED discharge
measure: Post concussive symptoms
timeFrame: 7 days after ED discharge
measure: Use of Rescue medication
timeFrame: Duration of ED admission, up to 3-4 days
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02032615: Let's be Well Red: Efficacy of Gudness Bars in Improving the Hemoglobin and Hematocrit Levels of Anemic Subjects
Official title: Let's Be Well Red (LBWR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar
Keywords: anemia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 358
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To test the efficacy of Gudness Bars in improving the hemoglobin and hematocrit levels of anemic subjects longitudinally.

To quantify the demographics of subjects attending anemia testing camps through LBWR and to explore correlations with the demographics data.


Eligibility criteria: Inclusion Criteria:

* Female
* Ages 18-35 years age

Exclusion Criteria:

* Known allergy towards nuts.

Primary outcomes:
measure: Hemoglobin level
timeFrame: 3 months
measure: Hematocrit level
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Lets Be Well Red
state: Maharashtra
Study officials:
affiliation: Duke University
name: Dennis Clements, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehta R, Platt AC, Sun X, Desai M, Clements D, Turner EL. Efficacy of iron-supplement bars to reduce anemia in urban Indian women: a cluster-randomized controlled trial. Am J Clin Nutr. 2017 Mar;105(3):746-757. doi: 10.3945/ajcn.115.127555. Epub 2017 Jan 18.
Clinical trial NCT01396915: Effects of Increased, Egg-Based Protein Intake on Muscle Composition,
Official title: Effects of Increased, Egg-Based Protein Intake on Muscle Composition,
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Composition
Sarcopenia
Hypertrophy
Inflammation
Keywords: Skeletal muscle lipid content
whole muscle volume
fasting glucose
insulin
blood urea nitrogen
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 22
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and Women between the ages of 65-80

Brief summary: This study is designed to assess the effect of a diet-controlled nutrition program utilizing an egg-based higher protein diet on muscle composition and size, and indices of metabolic health and markers of systemic inflammation in older men and women who are slightly overweight.


Eligibility criteria: Inclusion Criteria:

* Men and Women between the ages of 55-80
* Body Mass Index between 27-35
* Non Diabetic
* Normal liver, kidney and heart functions within 10% of clinical normalcy
* Not currently following a weight loss or other special /non balanced diets
* weight stable

Exclusion Criteria:

* fasting glucose \> 110 mg/dl
* blood pressure \> 160/110 mm Hg
* plasma total cholesterol \> 260 mg/dl
* LDL-cholesterol \>160mg/dl
* triacylglycerol\>400 mg/dl
* \>than 1 hour/week of habitual aerobic and /or resistance exercise
* Currently taking prescribed blood thinners

Primary outcomes:
measure: Effects of Increased, Egg-Based Protein Intake on Muscle Composition, Metabolic Health and Systemic Inflammation in Obese, Older Adults
timeFrame: December 31, 2013
Secondary outcomes:
Other outcomes:
Locations:
city: W. Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06511115: New Technologies for Enhancing Health in Older Adults
Official title: New Technologies for Improving Physical, Mental, and Cognitive Health in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older People
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 76
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: New technologies, such as mobile apps, health monitoring devices, interactive video games, and telemedicine platforms, have become invaluable for improving the physical, mental, and cognitive health of older adults. They help maintain flexibility, strengthen muscles, improve balance and posture, alleviate chronic pain, enhance sleep quality, and reduce stress and anxiety. Tools like the Nintendo Wii promote physical activity, improve coordination, and offer social interaction. Overall, these technologies support better mental health, emotional well-being, and independence, contributing to a higher quality of life for older adults.


Eligibility criteria: Inclusion Criteria:

* Be 60 years old or older.
* Present physical autonomy to participate in the technological and physical activities required by the study.
* Present current affiliation to the social health security system.
* Sign the informed consent.
* Understand the instructions, programs and technological protocols of this project.
* Complete more than 90% of the intervention with technology and exercise.

Exclusion Criteria:

* Present medical contraindications for performing physical tests or using technologies.
* Present diseases that limit cognitive performance and physical activity.
* Present vestibular diseases.
* Present rheumatological diseases that can be exacerbated by the use of technologies or stress articulate.
* Refusing to sign the informed consent

Primary outcomes:
measure: Balance and gait
timeFrame: Up to twelve weeks
measure: Chair sit and reach test
timeFrame: Up to twelve weeks
measure: Back scratch test
timeFrame: Up to twelve weeks
measure: 30 second chair stand test
timeFrame: Up to twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Agustín Aibar Almazán
Study officials:
References:
Clinical trial NCT01632215: Preoperative Gabapentine for Carpal Tunnel
Official title: Effect of Preoperative Gabapentine for Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carpal Tunnel Syndrome
Keywords: gabapentine
postoperative pain
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.

Detailed description: There was studied 40 patients. Group 1 patients received 600 mg of gabapentin 1 hour before surgery; G2 received placebo 1 hour before surgery.

Anesthesia was regional intravenous block. Postoperative analgesia when needed was with acetaminophen. If needed was administered codeine. The evaluation of neuropathic pain was made by DN4 questionnaire. Pain intensity was assessed by numeric scale at block and after 30min, 1h, 2h, 2wk, 4wk, 6m. It was noted the duration of analgesia, and the amount of acetaminophen and codeine.

The statistical program used for analysis of the results was the Instat Graph

Eligibility criteria: Inclusion Criteria:

* carpal tunnel syndrome

Exclusion Criteria:

* disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant

Primary outcomes:
measure: Pain Intensity
timeFrame: 6 months
Secondary outcomes:
measure: Chronic Pain
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal de São Paulo
name: Rioko K Sakata, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02208115: Post-exercise Appetite Responses in Type 1 Diabetes
Official title: A Comparison of the Appetite Responses to High and Low Glycemic Index Post-exercise Meals Under Matched Insulinemia and Fibre in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus
Exercise
Appetite
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Newcastle University
First posted: 2014-08-04
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators hypothesise that manipulating the glycaemic index of the meal after exercise will influence the acute appetite responses of Type 1 diabetes individuals


Eligibility criteria: Inclusion Criteria:

* Aged between 18-50 years old (male or female).
* Free from any diabetes related complications (apart from mild background diabetic retinopathy).
* HbA1c \<8.5%.
* Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
* Demonstrate normal cardiac function in response to exercise.

Exclusion Criteria:

* Aged younger than 18, or older than 50 years.
* Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
* HbA1c \>8.5%.
* Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or detemir, and lispro or aspart for at least 6 months before the start of the study.
* Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.

Primary outcomes:
measure: Acute subjective appetite responses
timeFrame: 4 hours post-exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Clinical Research Facility, Royal Victoria Infirmary
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Daniel J West, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell MD, Gonzalez JT, Rumbold PL, Walker M, Shaw JA, Stevenson EJ, West DJ. Comparison of appetite responses to high- and low-glycemic index postexercise meals under matched insulinemia and fiber in type 1 diabetes. Am J Clin Nutr. 2015 Mar;101(3):478-86. doi: 10.3945/ajcn.114.097162. Epub 2014 Dec 31.
Clinical trial NCT02869737: Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients
Official title: Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Trauma
Keywords: Point of Care Device; post traumatic coagulopathy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admited for a suspicion of severe trauma wirth active bleeding in a level I trauma center

Brief summary: Traumatic coagulopathy is frequent and is an independent risk factor of mortality. Its detection mainly relies upon classic biological test like the prothrombin time and the international normaliezd ratio (INR). These tests are not available at the bedside. Point of care (POC) device for INR measurement are now available like the Coaguchek, Roche, France. The aim of the present study is to test the correlation between the POC INR and the laboratory INR.


Eligibility criteria: Inclusion Criteria:

* Age \> 15 y-o
* Admission for severe trauma

Exclusion Criteria:

* Patients under oral anticoagulant

Primary outcomes:
measure: Concordance between POC INR and laboratory INR using 3 classes: normal < 1.1, moderate : 1.1-1.5, severe: >1.5
timeFrame: Admission
Secondary outcomes:
measure: Prediction of RBC transfusion
timeFrame: 24 hours post admission
measure: Prediction of FFP transfusion
timeFrame: 24 hours post admission
measure: In-hospital mortality assessed using patients' files
timeFrame: up to Day 28
measure: Injury severity (ISS)
timeFrame: Day 1
measure: Organ failure measured with the SOFA score at Day 1
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
citation: Mistral T, Boue Y, Bosson JL, Manhes P, Greze J, Brun J, Albaladejo P, Payen JF, Bouzat P. Performance of point-of-care international normalized ratio measurement to diagnose trauma-induced coagulopathy. Scand J Trauma Resusc Emerg Med. 2017 Jun 21;25(1):59. doi: 10.1186/s13049-017-0404-y.
Clinical trial NCT03980015: Inflammatory Responses in Solitary and Multiple Erythema Migrans
Official title: Inflammatory Responses in Borrelia Afzelii Culture Positive Patients With Early Disseminated or Early Localized Lyme Borreliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erythema Migrans
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
First posted: 2019-06-10
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with erythema migrans

Brief summary: The investigators will evaluate differences in host immune responses (levels of cytokines and chemokines, representative of innate, Th1, and Th17 immune responses) in acute sera from adult patients with solitary or multiple erythema migrans.


Eligibility criteria: Inclusion Criteria:

* erythema migrans in patients \> 18 years
* Borrelia afzelii isolated from skin

Exclusion Criteria:

* pregnancy or immunocompromising conditions
* taking antibiotic with antiborrelial activity within 10 days

Primary outcomes:
measure: inflammatory proteins in erythema migrans patients
timeFrame: at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Daša Stupica, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01963715: A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors
Official title: A Phase 1, Multi-center, Open-label Study of IMGN289 Administered Intravenously in Adult Patients With EGFR-positive Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: EGFR Positive Solid Tumors
Keywords: IMGN289
Antibody Drug Conjugate
antibody
EGFR
NSCLC
SCCHN
Head and neck
Squamous cell carcinoma
Solid tumor
Immunogen
Lung
Phase 1
Lead sponsor: ImmunoGen, Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.


Eligibility criteria: Inclusion Criteria:

* 18 years old at time of consent
* Diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable
* EGFR-positive tumor expression
* Adequate blood and organ function
* Must agree to use contraception while on study and for 12 weeks after the last dose of IMGN289 as applicable
* Must be willing and able to sign informed consent and follow the study schedule and other protocol requirements

Exclusion Criteria:

* Other anti-cancer treatment during the study
* Symptomatic brain metastases
* Other clinically significant disease as defined by the protocol
* Chronic skin condition that requires prescribed oral or intravenous treatment
* History of severe rash that required discontinuation of prior EGFR targeted therapy
* Receiving therapeutic doses of warfarin or heparin for anti-coagulation
* Known diagnosis of HIV or active viral hepatitis
* Women who are pregnant or breast feeding

Primary outcomes:
measure: Number of participants with dose limiting toxicities
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 2 years
measure: Area under the plasma concentration versus time curve
timeFrame: Up to 2 years
measure: Peak plasma concentration (Cmax) of IMGN289
timeFrame: Up to 2 years
measure: Presence of Human Anti Human Antibody and Human Anti Drug Antibody
timeFrame: Up to 2 years
measure: Tumor measurements per RECIST 1:1
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: ImmunoGen, Inc.
name: Andrea Vergara-Silva, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04838015: Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS
Official title: Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: MS-RR
Ocrelizumab
Switch
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject Suffering from relapsing-remitting MS

Brief summary: Multiple Sclerosis (MS) is a chronic, autoimmune, neurodegenerative disease; clinical events are mainly attributed to myelin destruction and inflammatory of the central nervous system.

The diagnosis resides in clinical and radiological criteria according to 2017 McDonald criteria.

Once the diagnosis of MS has been made, treatment should be initiated promptly, in order to delay the onset of severe disability in the long-term, even more ocrelizumab are a treatment of high efficacy.

Ocrelizumab is used as a first-line or second-line treatment in Relapsing Remitting MS (RRMS) It is an anti-CD20 monoclonal antibody that provides rapid depletion of circulating CD20+ B lymphocytes by complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity.

The main objective is the retrospective evaluation of the impact of ocrelizumab on the outcome of MS.

The secondary objective is the search of predictive factors of response to treatment.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Suffering from relapsing-remitting MS (RRMS)
* Supported in a neurology department at Strasbourg or Nancy University Hospital between 10/01/2018 and 11/31/2020.
* Treated with ocrelizumab 600mg every 6 months during the period from 01/10/2018 to 01/05/2020.
* Have had an M0, M3 / M6 and M12 MRI after initiation of treatment.
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Primary progressive multiple sclerosis (MS-PP), secondarily progressive (MS-SP)
* Subject not meeting all the inclusion criteria
* Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.)
* Subjects under safeguard of justice
* Subject under guardianship or guardianship

Primary outcomes:
measure: Retrospective study of the impact of ocrelizumab used in patients with multiple sclerosis
timeFrame: Files analysed retrospectively from October 01, 2018 to November 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hautepierre Clinical Investigation Center - Strasbourg University Hospitals
Study officials:
References: