louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01089972: Ultrasonographic Evaluation of the Radial and Ulnar Blood Flow After Radial Arterial Cannulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radial Artery, Regional Blood Flow
Keywords: radial artery
ulnar artery
catheterization
regional blood flow
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2010-03-19
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient(age \>20) who are scheduled for elective surgery and need arterial

Brief summary: The aim of this randomized study was to compare the impact of two different radial arterial catheters - 20G and 22G - on the changes of diameter, blood flow and velocity of radial artery and ulnar artery after induction of anesthesia and after cannulation.


Eligibility criteria: Inclusion Criteria:

* The patient who are scheduled for elective surgery and need arterial cannulation

Exclusion Criteria:

* Coronary occlusive disease
* Known or suspected upper extremity peripheral arterial disease
* Coagulopathy
* DM with peripheral neuropathy
* Infection at puncture site

Primary outcomes:
measure: Radial artery diameter and blood flow before and after cannulation
timeFrame: 30 min
measure: Ulnar artery diameter and blood flow before and after cannulation
timeFrame: 30 min
Secondary outcomes:
measure: The differences of radial artery diameter and blood flow after cannulation between catheter gauge(20- and 22-G)
timeFrame: 30 min
measure: The differences of ulnar artery diameter and blood flow after cannulation between catheter gauge(20- and 22-G)
timeFrame: 30 min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01769872: Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury
Official title: Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
Collaborators: name: Korea University Anam Hospital
First posted: 2013-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with spinal cord injury


Eligibility criteria: Inclusion Criteria:

* Subjects who understand and sign the consent form for this study
* Age : 19-70
* Clinical diagnosis of spinal cord injury(American Spinal Injury Association\[ASIA\] Impairment Scale\[AIS\] grade A or B or C)
* Duration of injury : \> 3 month

Exclusion Criteria:

* Subjects who must put on a respirator
* Subjects who had malignant tumor within 5 years
* Subjects with a infectious disease include HIV and hepatitis
* Subjects who injured brain or spinal cord before spinal cord injury
* Subjects with anemia or thrombocytopenia
* Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
* Subjects with congenital or acquired immunodeficiency disorders
* Patients with clouded consciousness or speech disorder
* treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
* participating another clinical trials within 3 months
* other serious disease or disorder that could seriously affect ability to participate in the study

Primary outcomes:
measure: ASIA (American Spinal Injury Association) scale
timeFrame: 32 weeks
Secondary outcomes:
measure: Magnetic Resonance Imaging
timeFrame: 32 weeks
measure: MEP/SSEP
timeFrame: 32 weeks
measure: ADL (activities of daily living)
timeFrame: 32 weeks
measure: SF-36
timeFrame: 32 weeks
measure: ODI (Oswestry Disability Questionnaire)
timeFrame: 32 weeks
measure: Frequency of Adverse Events
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Tai-Hyoung Cho, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02301572: Aggressive Onset Multiple Sclerosis: A Practical Definition and Study of Its Clinical Course
Official title: Aggressive Onset Multiple Sclerosis: A Practical Definition and Study of Its Clinical Course
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2014-11-26
Enrollment: 750
Sex: ALL
Minimum age (years): 0
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MS.

Brief summary: Chart review.

Detailed description: A chart review will be completed on patients with multiple sclerosis to determine potential early characteristics that might be helpful in defining aggressive onset MS and predicting subsequent disease course and disability

Eligibility criteria: Inclusion Criteria:

* Two or more relapses in the preceding year and 2 or more gadolinium enhancing lesions on brain MRI scan or a significant T 2 lesion burden or
* One relapse if it results in sustained EDSS of 3.0 along with 2 or more gadolinium enhancing lesions or significant T2 lesion burden ( T2 lesion burden being determined by factoring the number of lesions, the size of the lesions and lesion location)

Exclusion Criteria:

-

Primary outcomes:
measure: Disability outcome will be determined based on EDDS.
timeFrame: at the last visit (average time frame from baseline to last follow up visit expected to be 36 months)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jai Perumal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07017972: Data Collection and Professional Simulated Use Study to Develop an Embryo Quality AI Model
Official title: Multicenter Data Collection and Simulated-Use Assessment for CHLOE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fertility Disorders
Lead sponsor: Fairtility
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 4000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women undergoing IVF treatment

Brief summary: This protocol supports the reliable development and improvement of AI-based applications by enabling training, verification, and validation using high-quality real clinical data. It also aims to enhance machine learning in developmental-use AI software.

In addition, the professional user simulated use will ensure correct and easy use of the AI applications.

Detailed description: This data collection protocol aims to allow the reliable and robust development (training, verification, and validations) of AI technology-based applications as well as improving the machine learning stage of released devices/applications - an AI - based software, for developmental use only, through inspection of large body of high quality real clinical data. Another important element in the design of the application is the user interface. It is thus important to run simulated use assessments to ensure correct and easy use of the AI application by professional users.

Eligibility criteria: Inclusion Criteria:

1. Images and data of eggs or embryos available from egg retrievals by women undergoing standard egg-freezing or IVF treatments, using their own eggs or donor eggs.
2. Women at least 18 years of age.
3. Embryos or eggs cultured in a time-lapse incubator connected to the AI Embryo Viewer.

Exclusion Criteria:

* Women with no available own or donor eggs.

Primary outcomes:
measure: Area under the curve (AUC) will be quantified using logistic regression to assess EQ Score's prediction of utilization.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stamford
country: United States
facility: New England Fertility Institute
state: Connecticut
Study officials:
affiliation: Fairtility
name: Klaus Wiemer, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00529750: Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension
Official title: Comparative Trial of the Effects of Irbesartan vs Atenolol on the Endothelial Function of Hypertensive Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 108
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary:

* To evaluate the impact of irbesartan on endothelial function in hypertensive patients with metabolic syndrome.

Secondary:

* To evaluate the oxidative stress status in patients with hypertension with metabolic syndrome.
* To correlate the oxidative stress status with endothelial function in these patients.
* To evaluate the effect of irbesartan on the oxidative stress stage in patients with metabolic syndrome and to correlate it with the effect on endothelial function .
* To correlate the change in endothelial function and oxidative stress stage with the change of arterial pressure levels.


Eligibility criteria: Inclusion Criteria:

* Hypertension grade 1 or 2
* With at least two of the following criteria for the diagnosis of metabolic syndrome:

  * Body mass index \> or = 25 kg/m2 AND waist circumference \> or = 100 cm.
  * Dyslipidemia (triglycerides fasting serum levels \> or = 200 mg/dL OR HDL serum levels \< or = 40 mg/dL)
  * Fasting serum glucose \> or = 110 mg/dL but \< 126 mg/dL

Exclusion Criteria:

* Known hypersensitivity to Irbesartan
* Hypertension grade 3
* History of clinical vascular events such as TIAs, stroke, peripheral arterial disease
* Coronary artery disease
* Renal insufficiency (creatinine serum levels \> or = 1.2 mg/dL)
* Presence of clinical heart failure
* Asthma and COPD
* Valvular cardiopathy clinically relevant
* Current therapy with antioxidant drugs, statins
* Therapy with AIIRA for at least 3 months during the last semester
* Presence of any acute illness or major trauma in the last 8 weeks
* History of a chronic inflammatory disease such as rheumatoid arthritis, immune disorders or connective tissue disease.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Endothelial function in vivo qualification: brachial artery flow mediated vasodilation (FMV%) determined by high resolution ultrasound.
timeFrame: at baseline and at the end of the study-12th wk
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Juan Carlos Gomez
role: STUDY_DIRECTOR
References:
Clinical trial NCT05536050: Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia
Official title: Prospective Observational Pilot Study of Low-dose Naltrexone in Patients With Chronic Migraine With Comorbid Fibromyalgia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Migraine
Fibromyalgia
New Daily Persistent Headache
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be screened and enrolled by study personnel either during their visit with their referring physician, or remotely.

Brief summary: This research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. A few studies suggest low-dose naltrexone is effective for fibromyalgia, but it has not been studied in patients with migraine and headaches. Our goal is to see if there is an improvement in either severity and frequency of attacks and overall impact on quality of life over a three-month period.


Eligibility criteria: Inclusion Criteria:

* Subjects will be adults of all genders ages 18 and older.
* Patients with a diagnosis of CM (with or without NDPH) by IHC-3 criteria, diagnosed by a certified headache specialist.
* Subjects who received a new prescription for LDN
* Fibromyalgia-diagnosed according to Fibromyalgia Rapid Screening Tool
* Subjects should be on stable headache and migraine preventives for the past 2 months with no plans to change medication for the next 4 months.
* Subjects willing to maintain a headache/migraine diary one month prior to taking medication and while taking the medication, either physical or electronic diary of their choice.
* Subjects willing to fill out pre and post intervention surveys
* Subjects willing to comply with planned follow up phone calls and visits.

Exclusion Criteria:

* Not planning on follow up care with clinician.
* Patients with decreased decision-making capacity in which the investigator's opinion would interfere with the person's ability to provide informed consent and complete study questionnaires.

Primary outcomes:
measure: Effectiveness on migraine
timeFrame: 9-12 weeks
Secondary outcomes:
measure: Effectiveness on headache
timeFrame: 9-12 weeks
measure: Intensity
timeFrame: 9-12 weeks
measure: The Migraine Disability Assessment Test
timeFrame: 9-12 weeks
measure: Migraine Specific Quality of Life Index
timeFrame: 9-12 weeks
measure: Patient Health Questionnaire
timeFrame: 9-12 weeks
measure: Fibromyalgia Impact Questionnaire
timeFrame: 9-12 weeks
measure: Patients' Global Impression of Change
timeFrame: 9-12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04026750: Insulin Tolerance Test Study in Patients With Type 1 Diabetes
Official title: A Randomized, Double-Blind, Placebo-Controlled Insulin Tolerance Test Study to Assess the Safety, Tolerability, and Pharmacodynamics OF Pitolisant in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 1 Diabetes
Hypoglycemia
Lead sponsor: High Point Clinical Trials Center
Sponsor class: INDUSTRY
Collaborators: name: Ferox Therapeutics
First posted: 2019-07-19
Enrollment: 5
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: BASIC_SCIENCE

Brief summary: The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria: Diagnosis of diabetes =\> 4yrs, On Insulin =\> 4yrs, HbA1c\<= 10%, At least one episode of severe hypoglycemia in past 12 months, fasting c-peptide \<0.7 ng/ml

Exclusion Criteria:

* Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal function, Anxiety and depression

Primary outcomes:
measure: Change From Baseline in Peak Glucagon Response to Hypoglycemia
timeFrame: Change in peak glucagon during ITT Day 1 vs. Day 7
Secondary outcomes:
measure: Number of Patients Returning to Blood Glucose =>70 mg/dL
timeFrame: Day 7
Other outcomes:
Locations:
city: High Point
country: United States
facility: High Point Clinical Trials Center
state: North Carolina
Study officials:
affiliation: PI
name: Melanie Fein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01087372: Stress Hyperglycemia. Potential Role of Incretin Analogs
Official title: Stress Hyperglycemia in Critically Ill Patients. Potential Role of Incretin Analogs. A Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Critical Illness
Keywords: Stress hyperglycemia
Incretins
GLP-1
GIP
glucoregulatory hormones
Lead sponsor: Hospital Universitari Son Dureta
Sponsor class: OTHER
Collaborators: name: Fundació Mateu Orfila
First posted: 2010-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical-surgical ICU patients

Brief summary: This is a prospective observational study to examine the levels of glucoregulatory hormones, with special focus on incretins levels, in critically ill patients with stress hyperglycemia.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Emergent ICU admission
* Written informed consent from patient or relative.

Exclusion Criteria:

* Previously known type I or type II diabetes.
* Patients who received insulin or oral antidiabetic agents before ICU admission.
* Malignancies.
* Scheduled surgery
* Patients receiving enteral or parenteral nutrition.
* Inability to obtain informed consent.

Primary outcomes:
measure: Incretins plasmatic levels
timeFrame: 28 days
Secondary outcomes:
measure: glucagon
timeFrame: 28 days
measure: insulin
timeFrame: 28 days
measure: cortisol
timeFrame: 28 days
measure: HOMA index
timeFrame: 28 days
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Dureta. Intensive Care Unit
state: Illes Balears
Study officials:
affiliation: Hospital Universitari Son Dureta. Intensive Care Unit
name: Juan A Llompart-Pou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Llompart-Pou JA, Fernandez-de-Castillo AG, Burguera B, Perez-Barcena J, Marse P, Rodriguez-Yago M, Barcelo A, Raurich JM. Stress hyperglycaemia in critically ill patients: potential role of incretin hormones; a preliminary study. Nutr Hosp. 2012 Jan-Feb;27(1):130-7. doi: 10.1590/S0212-16112012000100015.
Clinical trial NCT06154772: Quality of Life, Anxiety and Fatigue Level of Parkison's Patients With Color Therapy
Official title: The Effect of Color Therapy on Quality of Life, Anxiety and Fatigue Levels of Parkison Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson
Keywords: Color therapy
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to investigate the effect of color therapy on quality of life, anxiety and fatigue levels in patients with Parkinson's disease.

Detailed description: Color Therapy aims to balance and heal our body's energy centers using the seven color spectrum, which helps to promote our body's own healing process. Thus good health and well-being is achieved through the balance of all these energies. Color therapy basically consists of color and character analysis with name, color therapy with chakras, programming of the pendulum, chakras and color application, color application with water, color application with colored light device.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with Parkinson's disease for at least 6 months,
* Those who have not taken sleeping pills or sedative drugs,
* Not having undergone brain stimulation surgery,
* Do not have a physical illness or cognitive disability that would prevent them from understanding the education provided, and do not have a diagnosis of a psychiatric disease,
* According to the Parkinson's Fatigue Scale, the scale score is \>8
* The patient or someone living in the same house with the patient is literate,
* Patients have no vision problems.

Exclusion Criteria:

* Parkinson patients who did not agree to participate in the research

Primary outcomes:
measure: Quality of Life Scale (SF36)
timeFrame: At the end of Color Therapy (therapy 9 times in total in 3 months)
measure: Beck Anxiety Inventory (BAI)
timeFrame: At the end of Color Therapy (therapy 9 times in total in 3 months)
measure: Parkinson's Fatigue Scale (PYO-16)
timeFrame: At the end of Color Therapy (therapy 9 times in total in 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Elazıg
country: Turkey
facility: Firat University
Study officials:
References:
Clinical trial NCT06674772: Molecular Phenotyping of Migraine Patients According to Sex and Age Through CGRP Quantification
Official title: Fenotipado Molecular De Pacientes Con Migraña Según Edad Y Sexo a Través De La Cuantificación De CGRP En Saliva Para Realizar Medicina De Precisión: Estudio FAST
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Headache (Migraine)
Migraine
Migraine Headache
Migraine with Aura
Migraine Without Aura
Episodic Migraine
Chronic Migraine Headache
Chronic Migraine, Headache
Episodic Migraine Headache
Keywords: Migraine
CGRP
saliva
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 440
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females otherwise healthy with episodic and chronic migraine in different age groups will be included in the study. Controls matching age and sex will be selected for the control groups.

Brief summary: Patients will be asked to visit the study center 2 times, the first time for clinical assessment and a second time for sample collection. Healthy controls will only be asked to visit the study center for sample collection. A sample of blood and saliva will be collected in order to measure CGRP levels and DNA and hormone testing.

Detailed description: CGRP is a neuropeptide related to migraine pathophysiology, which can be found in human saliva in both patients and healthy controls. The differences in CGRP levels may help us explain the differences in the treatment response.

A sample of saliva will be collected in order to measure CGRP levels and a blood sample will be collected in order to conduct a DNA test and hormones test.

Eligibility criteria: Inclusion Criteria:

* Migraine patients according to ICHD-3 criteria
* Healthy controls paired to patient age and sex, without headache and without first degree family history of headache.

Exclusion Criteria:

* Presence of any major medical or neurological illness.
* Presence of any salivary gland malfunction.
* Abuse or dependence to tobacco, alcohol or any drug in the previous 12 months before the enrollment.
* Active migraine preventive treatment.
* Pregnant or breastfeeding female.

Primary outcomes:
measure: CGRP level
timeFrame: Through study completion, an average of 1 year
measure: Hormone levels
timeFrame: Through study completion, an average of 1 year
measure: DNA test
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
Study officials:
References: