louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01750723: Acetazolamide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
Official title: Basic Research on Acetazolamide´s Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow in a Humane Experimental Headache Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Migraine
Keywords: Acetazolamide
Headache
Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the investigators will research the hypothesis that the drug Acetazolamide induce headache and dilation of cerebral arteries and increase the cerebral blood flow in the areas of the brain supplied by these arteries.

Detailed description: To investigate headache score and accompanying symptoms during and after infusion of acetazolamide.

With magnetic resonance imaging the investigators will investigate changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), diameter of MCA, the Internal carotic artery (ICA), the superficial temporal artery (STA) and the Medial Meningeal artery (MMA).

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Aged 18-40
* 50-100 kg
* Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

Exclusion Criteria:

* Tension type headache more than once/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease

Primary outcomes:
measure: Headache scores
timeFrame: 24 h
Secondary outcomes:
measure: Artery circumference
timeFrame: Baseline, 30 min and 60 min
measure: Cerebral blood flow
timeFrame: Baseline, 30 and 60 min.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center
state: Glostrup
city: Copenhagen
country: Denmark
facility: Department of Neurology
state: Glostrup
Study officials:
affiliation: Danish Headache Center
name: Nanna Arngrim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00215423: Study in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Chronic Obstructive Pulmonary Disease
Keywords: COPD
Chronic Obstructive Pulmonary Disease
Formoterol Fumarate
Formoterol
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 49
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which dose of the investigational drug is the most safe and effective for the treatment of COPD compared to the control drug


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* History of cigarette smoking

Exclusion Criteria:

* Clinical diagnosis of asthma
* Significant pulmonary disease other than COPD
* Other significant major organ disease(s)

Primary outcomes:
measure: Measure of lung function
Secondary outcomes:
measure: Change in lung function, as well as vital signs
measure: Physical Exam results, adverse event reporting, etc
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Wheat Ridge
country: United States
facility: Research Site
state: Colorado
city: Hines
country: United States
facility: Research Site
state: Illinois
city: Shawnee Mission
country: United States
facility: Research Site
state: Kansas
city: Butte
country: United States
facility: Research Site
state: Montana
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Medford
country: United States
facility: Research Site
state: Oregon
Study officials:
References:
citation: Gross NJ, Kerwin E, Levine B, Kim KT, Denis-Mize K, Hamzavi M, Carpenter M, Rinehart M. Nebulized formoterol fumarate: Dose selection and pharmacokinetics. Pulm Pharmacol Ther. 2008 Oct;21(5):818-23. doi: 10.1016/j.pupt.2008.07.002. Epub 2008 Jul 8.
Clinical trial NCT06309823: A Single-patient Clinical Trial of MAS825 in a Patient With XIAP Deficiency
Official title: A Single-patient Clinical Trial of MAS825 in a Patient With XIAP Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: X-linked Lymphoproliferative Syndrome Type 2 (XLP-2)
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 1
Sex: MALE
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: MAS825 is a bi-specific IgG1 monoclonal antibody that simultaneously targets IL-1 beta and IL-18, thereby neutralizing both cytokines that are thought to be integral to the pathogenesis of XLP-2. Clinical trials are currently examining its efficacy in other diseases associated with elevations of these cytokines, including NLRC4-associated disease and hidradenitis suppurativa. This study proposes to assess the effectiveness of MAS825 in a single patient with XLP-2, who has previously demonstrated response to blockade of IL-1 beta and IL-18. Given the lack of alternative pharmaceutical options for XLP-2, this represents the only known medication option that avoids the toxicity associated with high-dose corticosteroids and the morbidity associated with hematopoietic stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

* Known patient with XIAP genetic defect under the care of the investigator

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Impact of MAS825 on Physician Global Assessment Score
timeFrame: 5 years
measure: Impact of MAS825 on Physician Severity Assessment of Disease Signs and Symptoms
timeFrame: 5 years
measure: Patient/Parent Global Assessment of Disease Activity
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT03530423: Sensing Ventricular Arrhythmias by His Bundle Leads
Official title: Sensing Ventricular Arrhythmias by His Bundle Leads
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals undergoing routine defibrillation threshold testing of a right ventricular implantable cardioverter defibrillator lead who also have previously placed His bundle lead or who are undergoing placement of a His bundle lead.

Brief summary: The purpose of this trial is to determine if implantable cardiac device leads implanted in the His bundle are capable of detecting ventricular arrhythmias.

Detailed description: During routine testing of implanted leads, the His bundle lead will be connected to a separate device with all therapies disabled. Testing will be done to see if the His bundle lead can detect ventricular arrhythmias.

Eligibility criteria: Inclusion Criteria:

* Individuals undergoing routine defibrillation threshold testing of a right ventricular implantable cardioverter defibrillator lead who also have previously placed His bundle lead or who are undergoing placement of a His bundle lead.

Exclusion Criteria:

* Individuals with contraindications to defibrillation threshold testing

Primary outcomes:
measure: Detection of ventricular arrhythmia from His bundle
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Pramod Deshmukh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03508323: Tenelia Elderly CGMS Study(TEDDY)
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase IV Study to Evaluate the Efficacy and Safety of Tenelia® in Patients Aged 65 and Older With Inadequately Controlled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-25
Enrollment: 65
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.

Detailed description: To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* Patients who are 65 years or older on screening
* Patients with type 2 diabetes mellitus
* Patients with 7.0% ≤ HbA1c ≤ 9.0% at the screening visit
* Patients with FPG \< 270mg/dL on screening visit

Exclusion Criteria:

-

Primary outcomes:
measure: HbA1c
timeFrame: after 12wks on baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: JH Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bae JC, Kwak SH, Kim HJ, Kim SY, Hwang YC, Suh S, Hyun BJ, Cha JE, Won JC, Kim JH. Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study). Diabetes Metab J. 2022 Jan;46(1):81-92. doi: 10.4093/dmj.2021.0016. Epub 2021 Jun 16.
Clinical trial NCT05893823: Retrospective Study on Radiological Factors Predictive of Psoas Impingement
Official title: Retrospective Study on Radiological Factors Predictive of Symptomatic Psoas Impingement Development in Protruding Cups in Primary Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Impingement Syndrome
Prosthetic Complication
Keywords: Iliopsoas Impingement
Overhanging Cup
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had undergone a total hip arthroplasty with symptoms of iliopsoas impingement and radiological evidence of a protruding acetabular cup, detected on a Ct scan

Brief summary: The purpose of this study is to identify radiological factors on TC of the hip that could lead to prediction of development of symptomatic psoas impingement in patients with protruding acetabular cup after primary total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Primary total hip arthroplasty
* Execution of a postoperative Ct scan for pain, noises or planning of the contralateral THA
* 5 years minimum follow-up for the control group, tenotomy of the iliopsoas muscle in the cases group
* Complete clinical and radiological data

Exclusion Criteria:

* Patient's refusal to participate
* Non adequate Ct scans or made for periprosthetic fractures, component mobilization, periprosthetic infection or wearing of the prosthesis
* Incomplete clinical and radiological data
* Inadequate follow-up or regression of the iliopsoas impingement symptoms with non-operative treatment

Primary outcomes:
measure: Acetabular cup antiversion
timeFrame: 0
measure: Acetabular cup inclination
timeFrame: at baseline (day 0)
measure: Femoral offset
timeFrame: at baseline (day 0)
measure: Acetabular offset
timeFrame: at baseline (day 0)
measure: Eccentric Reaming
timeFrame: at baseline (day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: Emilia Romagna
Study officials:
References:
Clinical trial NCT01731223: Group Treatment for Insomnia in Primary Health Care
Official title: Group Treatment for Insomnia in Primary Health Care: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Primary health care
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Karolinska Institutet
First posted: 2012-11-21
Enrollment: 165
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 aim of this study is to analyze if group treatment is effective to treat insomnia in primary healthcare.

Detailed description: Insomnia is a common health problem. Untreated insomnia may lead to decreased physical and mental health. The patients turns to Primary Health Care when daytime symptoms decrease social and occupational function. Previous studies have shown that cognitive and behavioral therapy have effects on insomnia and recommends as first line treatment but is not widely available in primary health care.

The purpose is to test the effect of group intervention in Primary Health Care for patients with insomnia. The outcomes is insomnia severity, sleep habits, use of hypnotics, Fatigue, general health and health related quality of life. Characters with insomnia visiting in Primary Health Care.

Eligibility criteria: Inclusion Criteria:

* Insomnia symptoms regarding DSM-V
* Motivated to group treatment.

Exclusion Criteria:

* Insomnia Severity Index less than 7 points
* Presence of acute life crises, acute psychiatric illness, bipolar disorder
* Shift work
* Linguistic or cognitive difficulties causing inability participate in group or fill in forms
* Insomnia directly caused by medical illness. Other sleep disorder.

Primary outcomes:
measure: Insomnia severity Index
timeFrame: One year
Secondary outcomes:
measure: Fatigue severity scale
timeFrame: one year
Other outcomes:
measure: Sleep Logg
timeFrame: one year
Locations:
city: Stockholm
country: Sweden
facility: Centre for family medicine
state: Huddinge
city: Stockholm
country: Sweden
facility: Centrum för allmanmedicin
state: Huddinge
Study officials:
affiliation: Karolinska Institutet
name: Jeanette Westman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeBlanc M, Beaulieu-Bonneau S, Merette C, Savard J, Ivers H, Morin CM. Psychological and health-related quality of life factors associated with insomnia in a population-based sample. J Psychosom Res. 2007 Aug;63(2):157-66. doi: 10.1016/j.jpsychores.2007.03.004.
citation: Wilson SJ, Nutt DJ, Alford C, Argyropoulos SV, Baldwin DS, Bateson AN, Britton TC, Crowe C, Dijk DJ, Espie CA, Gringras P, Hajak G, Idzikowski C, Krystal AD, Nash JR, Selsick H, Sharpley AL, Wade AG. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol. 2010 Nov;24(11):1577-601. doi: 10.1177/0269881110379307. Epub 2010 Sep 2.
Clinical trial NCT01047150: The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetro and Tc-99m Mibi
Official title: The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetrofosmin and Tc-99m Sestamibi
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Ischemia
Keywords: Myocardial Perfusion Imaging
Repeat studies
Tetrofosmin
Sestamibi
Lead sponsor: Cardiac Imaging of Augusta
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2010-01-12
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for MPI

Brief summary: Research Questions:

1. Is there a significant difference between the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi?
2. Is there a significant difference in the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi if an independent technologist reviewer blinded to the radiopharmaceutical makes the decision to repeat the study?
3. Is there a significant difference in the quantitative diagnostic measures reported between the original and the acceptable repeated studies?

Detailed description: There are two commonly used Tc-99m based radiopharmaceuticals useful in the diagnosis and localization of regions of reversible myocardial ischemia in the presence or absence of infarction under exercise and rest conditions. One is Tc-99m tetrofosmin (Tc-99m-1,2-bis\[bis(2-ethoxyethyl) phosphino\] ethane), the other is Tc-99m sestamibi (Tc-99m- methoxyisobutylisonitrile). When performing a myocardial perfusion SPECT (MPS) study, extracardiac subdiaphragmatic activity adjacent to the myocardium can cause artifacts in the inferior wall and can be detrimental to the accuracy of the study1,2. Following acquisition, MPS studies are routinely checked for potential imaging artifacts. When a separation between the extracardiac activity cannot clearly be distinguished from the myocardium, the study should be repeated. Repeating the SPECT study can affect the efficiency of a lab as well as having a negative influence on patient comfort and overall satisfaction. The goal of this study is to determine if there is a significant difference in the number of studies that should be repeated between the two commonly used radiopharmaceuticals.

Eligibility criteria: Inclusion Criteria:

* Patients receiving sestamibi MPI study or tetrofosmin MPI study

Exclusion Criteria:

* Thallium or dual isotope MPI study

Primary outcomes:
measure: Number of studies repeated.
timeFrame: four weeks
Secondary outcomes:
measure: Number of studies that should have been repeated
timeFrame: two weeks after data collection
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Cardiac Imaging of Augusta
state: Georgia
Study officials:
affiliation: Cardiac Imaging of Augusta
name: Danny A Basso, CNMT
role: STUDY_DIRECTOR
References:
Clinical trial NCT04475250: Train-of-four Monitoring Using the Tetragraph
Official title: Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients requiring anesthetic care and use of neuromuscular blockade
* Weight range of 20 - 60 kg

Exclusion Criteria:

* Patients with history of a peripheral neurologic or neuropathic disorder
* Patients in whom the upper extremity cannot be used for TOF monitoring
* Patients undergoing a surgical procedure in which neuromuscular blockade is not required
* Edematous patients

Primary outcomes:
measure: Baseline TOFr (%)
timeFrame: Immediately prior to start of surgery
measure: Recovered TOFr (%)
timeFrame: At the end of surgery (maximum 7 hours from baseline)
Secondary outcomes:
measure: Baseline Amplitude (mV)
timeFrame: Immediately prior to start of surgery
measure: Recovered Amplitude (mV)
timeFrame: At the end of surgery (maximum 7 hours from baseline)
measure: Rate of Muscle Recovery (Minutes)
timeFrame: At the end of surgery (maximum 7 hours from baseline)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00913250: A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers
Official title: A Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of AVONEX® (Interferon Beta-1a) Solutions for Injection Produced by a Serum-Containing Manufacturing Process and by a Serum-Free Manufacturing Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Interferon beta-1a
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions
* History of hypersensitivity to acetaminophen (paracetamol), ibuprofen, or codeine.
* Known allergy to dry natural rubber
* History of seizure disorder or unexplained blackouts
* History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease

Other inclusion and exclusion criteria apply as per protocol

Primary outcomes:
measure: To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers.
timeFrame: Study duration is 72 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Biogen-Idec Investigator
role: PRINCIPAL_INVESTIGATOR
References: